Recent studies conducted at the Institut de recherches cliniques de Montreal (IRCM) on a group of PCSK enzymes could have a positive impact on health, from cholesterol to osteoporosis. A team led by Dr. Nabil G. Seidah, Director of the Biochemical Neuroendocrinology research unit, has published six articles in prestigious scientific journals over the past four months, all shedding light on novel functions of certain PCSK enzymes.
PCSK enzymes belong to the proprotein convertase family, responsible for the conversion of an inactive protein into its active state. The latest projects led by Dr. Seidah and his team focused on five of the nine PCSK enzymes, which are implicated in diseases such as cardiovascular and neuroendocrine disorders, cancer, and viral infections.
PCSK9 could help lower bad cholesterol levels
A member of the proprotein convertase family, PCSK9 plays a key role in the regulation of cholesterol. It is involved in causing familial hypercholesterolemia, a genetic disorder characterized by high total cholesterol levels in the blood, specifically very high levels of LDL (low-density lipoprotein) or bad cholesterol, which can lead to the early onset of cardiovascular diseases. PCSK9 is thus a target for the treatment of dyslipidemia, which results from an abnormal concentration of lipids (fat) in the blood. It is believed that inhibition of PCSK9 function could lower LDL-cholesterol levels, and such treatments are currently undergoing early phase clinical trials.
"Members of my team, led by Dr. Annik Prat and Dr. Anna Roubtsova, discovered that PCSK9 also regulates fatty acids," explains Dr. Seidah. "They investigated its role in the metabolism of body fat, and found that PCSK9 is pivotal in regulating cholesterol and fat metabolism: it maintains high circulating cholesterol levels, but it also limits fat generation."
In another study, the researchers uncovered further data on PCSK9's mechanism of action and functional structure. Their data showed that a part of PCSK9 inhibits its own function, and that acidic pH levels affect the degradation of bad cholesterol receptors.
In a third study, the team discovered that two other PCSK enzymes, Furin (PCSK3) and PC5/6 (PCSK5), reduce the level of active PCSK9. "They were able to demonstrate how enzymes of the PCSK family communicate with one another and found that liver-derived Furin cuts PCSK9 and inactivates it," adds Dr. Seidah. "This provided genetic evidence for the mechanism behind the functioning of a mutant gene found in some human hypercholesterolemic patients."
An important enzyme for osteoporosis, especially for women after menopause
The eighth member of the family (PCSK8), known as SKI-1/S1P, is critical in the intracellular pathway leading to the synthesis of cholesterol and fatty acids. Researchers discovered a new function of the enzyme in the regulation of bone formation. They demonstrated that mineralization - the process by which the body uses minerals to build bone structure - was blocked by inhibitors of SKI-1/S1P.
"The team found that SKI -1/S1P also regulates the activation of a membrane-bound transcription factor required for bone formation, which could have an impact on osteoporosis," says Dr. Seidah. "This could be especially important for women after menopause, as they are most likely to develop bone disease."
A better understanding of an enzyme implicated in various cancers
PC7 (or PCSK7) is the most ancient and highly-conserved basic amino acid-specific member of the proprotein convertase family. The team of researchers, led by Estelle Rousselet, shed light on how PC7 functions within cells, and was able to define its intracellular trafficking pathways. "We identified a mechanism for PC7's unique ability to activate the precursor of epidermal growth factor, which is involved in various cancers, tumour growth, and the maintenance of stem cells," concludes Dr. Seidah.
воскресенье, 29 мая 2011 г.
четверг, 26 мая 2011 г.
Mipomersen Phase 3 Study In Patients With Heterozygous Familial Hypercholesterolemia Meets Primary Endpoint
Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) announced that the phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH) met its primary endpoint with a highly statistically significant 28 percent reduction in LDL-cholesterol after 26 weeks of treatment, compared with an increase of 5 percent for placebo.
All of the 124 patients in the study had pre-existing coronary artery disease, were taking a maximally tolerated dose of a statin and in many cases additional lipid-lowering drugs. Patients' average LDL-C at baseline was 150 mg/dL. Patients treated with mipomersen had an average LDL-C level of 104 mg/dL at the end of the study. Forty-five percent of the mipomersen-treated patients achieved LDL-C levels of less than 100 mg/dL, a recognized treatment goal for high-risk patients. The reductions observed in the study were in addition to those achieved with the patients' existing therapeutic regimens.
"The average reduction in LDL-C of 28 percent in these high-risk, difficult-to-treat patients with severe inherited high cholesterol is very encouraging," said Evan A. Stein, M.D., Ph.D., Director of the Metabolic & Atherosclerosis Research Center, Cincinnati, Ohio, and an investigator on the study. "The nearly 50 mg/dL additional decrease in LDL-C when added to maximally tolerated statin therapy is above what we have seen with any other agent in this population, and the side effect profile of mipomersen continues to be acceptable."
The trial also met each of its three secondary endpoints with statistically significant reductions in apo-B, total cholesterol, and non-HDL-cholesterol. Study results are based on an intent-to-treat analysis (full analysis set). Data will be submitted for presentation at a future medical meeting.
"We are excited by these strong data in the second phase 3 trial of mipomersen," said Genzyme Chief Medical Officer Richard A. Moscicki, M.D. "This therapy has the potential to make a major difference in the lives of patients who are in great need of new treatment options. With these data, we remain on-track with our development plan for mipomersen."
There were no new areas of safety concerns identified in the trial. Of the 83 patients treated with mipomersen, 73 completed the study; nine of the discontinuations were related to adverse events. Consistent with previous studies evaluating mipomersen, the most commonly observed adverse events were injection site reactions and flu-like symptoms.
As in other mipomersen trials, elevations in liver transaminases were observed that were similar in magnitude and duration to those seen in other studies. None of these patients had changes in other laboratory tests to indicate hepatic dysfunction, and there were no Hy's Law cases.
"Mipomersen has again delivered positive results with this second phase 3 study, and continues to make progress toward the market," said Stanley Crooke, Chairman and Chief Executive Officer of Isis Pharmaceuticals. "Mipomersen represents the power of antisense technology and reflects our commitment to innovation and technological advancement to create potent and specific drugs to help people lead healthier and more hopeful lives."
The study was a randomized, double-blind, placebo-controlled trial that enrolled 124 heFH patients, aged 18 and older with LDL-C levels greater than 100 mg/dL. Patients were randomized 2:1 to receive a 200 mg dose of mipomersen or placebo weekly for 26 weeks. The trial was conducted at 26 sites in the United States and Canada.
Late-Stage Development Plan
Genzyme's initial U.S. and E.U. regulatory filings for mipomersen will seek marketing approval for the treatment of patients with homozygous FH (hoFH). The phase 3 study of mipomersen in hoFH met its primary endpoint with a 25 percent reduction in LDL-C, and results were presented at the annual American Heart Association meeting in November. In the first half of 2011, Genzyme expects to file for U.S. and E.U. approval of the treatment and to have made progress toward filing in other major international markets.
These two filings may also include patients with severe hypercholesterolemia. A phase 3 study of mipomersen in patients with severe hypercholesterolemia is fully enrolled with 58 patients and data are anticipated in mid-2010. The companies have also completed enrollment in a phase 3 trial involving 158 hypercholesterolemic patients at high risk for coronary heart disease, and data are anticipated in mid-2010.
About Mipomersen
Mipomersen is a first-in-class apo-B synthesis inhibitor currently in late-stage development. It is intended to reduce LDL-C by preventing the formation of atherogenic lipids. It acts by decreasing the production of apo-B, which provides the structural core for all atherogenic lipids, including LDL-C, which carry cholesterol through the bloodstream.
About Familial Hypercholesterolemia
FH is a genetic disorder that results in elevated LDL cholesterol levels. FH patients are unable to properly metabolize LDL-C due to dysfunctional LDL receptors, which are responsible for clearing LDL from plasma. These patients experience a markedly increased risk of premature cardiovascular disease (CVD) and CVD-related death.
There are two forms of FH: homozygous (hoFH), where a defective gene is inherited from both parents, or heterozygous (heFH), where a defective gene is inherited from only one parent so that some LDL receptor function is preserved. HoFH is a very rare condition estimated to affect approximately one in a million people worldwide. HeFH is a more common form of the disorder, with a prevalence of approximately one in 500.
Source
Genzyme
Isis
All of the 124 patients in the study had pre-existing coronary artery disease, were taking a maximally tolerated dose of a statin and in many cases additional lipid-lowering drugs. Patients' average LDL-C at baseline was 150 mg/dL. Patients treated with mipomersen had an average LDL-C level of 104 mg/dL at the end of the study. Forty-five percent of the mipomersen-treated patients achieved LDL-C levels of less than 100 mg/dL, a recognized treatment goal for high-risk patients. The reductions observed in the study were in addition to those achieved with the patients' existing therapeutic regimens.
"The average reduction in LDL-C of 28 percent in these high-risk, difficult-to-treat patients with severe inherited high cholesterol is very encouraging," said Evan A. Stein, M.D., Ph.D., Director of the Metabolic & Atherosclerosis Research Center, Cincinnati, Ohio, and an investigator on the study. "The nearly 50 mg/dL additional decrease in LDL-C when added to maximally tolerated statin therapy is above what we have seen with any other agent in this population, and the side effect profile of mipomersen continues to be acceptable."
The trial also met each of its three secondary endpoints with statistically significant reductions in apo-B, total cholesterol, and non-HDL-cholesterol. Study results are based on an intent-to-treat analysis (full analysis set). Data will be submitted for presentation at a future medical meeting.
"We are excited by these strong data in the second phase 3 trial of mipomersen," said Genzyme Chief Medical Officer Richard A. Moscicki, M.D. "This therapy has the potential to make a major difference in the lives of patients who are in great need of new treatment options. With these data, we remain on-track with our development plan for mipomersen."
There were no new areas of safety concerns identified in the trial. Of the 83 patients treated with mipomersen, 73 completed the study; nine of the discontinuations were related to adverse events. Consistent with previous studies evaluating mipomersen, the most commonly observed adverse events were injection site reactions and flu-like symptoms.
As in other mipomersen trials, elevations in liver transaminases were observed that were similar in magnitude and duration to those seen in other studies. None of these patients had changes in other laboratory tests to indicate hepatic dysfunction, and there were no Hy's Law cases.
"Mipomersen has again delivered positive results with this second phase 3 study, and continues to make progress toward the market," said Stanley Crooke, Chairman and Chief Executive Officer of Isis Pharmaceuticals. "Mipomersen represents the power of antisense technology and reflects our commitment to innovation and technological advancement to create potent and specific drugs to help people lead healthier and more hopeful lives."
The study was a randomized, double-blind, placebo-controlled trial that enrolled 124 heFH patients, aged 18 and older with LDL-C levels greater than 100 mg/dL. Patients were randomized 2:1 to receive a 200 mg dose of mipomersen or placebo weekly for 26 weeks. The trial was conducted at 26 sites in the United States and Canada.
Late-Stage Development Plan
Genzyme's initial U.S. and E.U. regulatory filings for mipomersen will seek marketing approval for the treatment of patients with homozygous FH (hoFH). The phase 3 study of mipomersen in hoFH met its primary endpoint with a 25 percent reduction in LDL-C, and results were presented at the annual American Heart Association meeting in November. In the first half of 2011, Genzyme expects to file for U.S. and E.U. approval of the treatment and to have made progress toward filing in other major international markets.
These two filings may also include patients with severe hypercholesterolemia. A phase 3 study of mipomersen in patients with severe hypercholesterolemia is fully enrolled with 58 patients and data are anticipated in mid-2010. The companies have also completed enrollment in a phase 3 trial involving 158 hypercholesterolemic patients at high risk for coronary heart disease, and data are anticipated in mid-2010.
About Mipomersen
Mipomersen is a first-in-class apo-B synthesis inhibitor currently in late-stage development. It is intended to reduce LDL-C by preventing the formation of atherogenic lipids. It acts by decreasing the production of apo-B, which provides the structural core for all atherogenic lipids, including LDL-C, which carry cholesterol through the bloodstream.
About Familial Hypercholesterolemia
FH is a genetic disorder that results in elevated LDL cholesterol levels. FH patients are unable to properly metabolize LDL-C due to dysfunctional LDL receptors, which are responsible for clearing LDL from plasma. These patients experience a markedly increased risk of premature cardiovascular disease (CVD) and CVD-related death.
There are two forms of FH: homozygous (hoFH), where a defective gene is inherited from both parents, or heterozygous (heFH), where a defective gene is inherited from only one parent so that some LDL receptor function is preserved. HoFH is a very rare condition estimated to affect approximately one in a million people worldwide. HeFH is a more common form of the disorder, with a prevalence of approximately one in 500.
Source
Genzyme
Isis
суббота, 14 мая 2011 г.
CDC Report Provides First State-Specific Data On Persons Living With Heart Disease
The Centers for Disease
Control and Prevention (CDC) today released a report that finds a wide
range of variation in the prevalence of coronary heart disease (a narrowing
of the arteries that feed the heart), heart attack and angina (chest pain
that occurs when the heart does not get enough blood). The report provides
the first ever information on the percentage of people living with heart
disease in all 50 states and U.S. territories. The report found that some
states and territories had double the prevalence of heart disease as
others. For heart attacks, rates ranged from 2.1 percent in the U.S. Virgin
Islands to 6.1 percent in West Virginia, while the prevalence of any
condition -- heart attack, angina or coronary heart disease -- ranged from
3.5 percent in the U.S. Virgin Islands to 10.4 percent in West Virginia.
The study, Prevalence of Heart Disease - United States, 2005, was
published in today's Morbidity and Mortality Weekly Report. The study is
based on an analysis of state-specific data collected from the Behavioral
Risk Factor Surveillance System -- a random phone survey of U.S. adults age
18 and older conducted by state/territorial health departments.
Overall, about 6.5 percent of those surveyed reported that a doctor or
health care professional had told them they had one or more of the
following - - heart attack, angina or coronary heart disease -- with 4
percent indicating they had a heart attack and 4.4 percent reporting angina
or coronary heart disease. Heart disease is the leading cause of death in
the United States.
"These findings show the importance of preventing and controlling known
risk factors for heart disease, such as high blood cholesterol, tobacco
use, physical inactivity, high blood pressure, type 2 diabetes, and
obesity," said Jonathan Neyer, the study's lead author and an
epidemiologist in CDC's Division for Heart Disease and Stroke Prevention
(DHDSP). "We hope this report will help states and U.S. territories better
tailor their heart disease prevention efforts."
Residents of Alabama, Arizona, Florida, Kentucky, Louisiana, Missouri,
Oklahoma, Tennessee, Texas, and West Virginia had the highest prevalence of
these heart diseases. Many of these states are known to have a high
proportion of residents with multiple heart disease risk factors and a
disproportionately high number of heart disease deaths. The same was found
among residents living in Puerto Rico.
The places reporting the lowest level of heart disease prevalence were:
Nebraska, Wisconsin, Wyoming, New Mexico, Montana, Minnesota, Utah, Hawaii,
Colorado, District of Columbia and the U.S. Virgin Islands.
The report also identified gender and racial/ethnic differences in
heart disease prevalence. Men had a significantly higher prevalence than
women (8.2 percent vs. 5 percent) for coronary heart disease or non-fatal
heart attack, and angina. American Indians/Alaska Natives had the highest
heart disease prevalence (11.2 percent) and Asians had the lowest
prevalence (4.7 percent). There was little difference in heart disease
prevalence among whites (6.9 percent), blacks (6.2 percent) or Hispanics
(6.2 percent).
The report also identified differences in prevalence based on
educational levels. Heart disease prevalence was nearly twice as high in
individuals with fewer than 12 years of education (9.8 percent) compared to
college graduates (5 percent).
CDC works with nearly 80 national organizations through the National
Forum for Heart Disease and Stroke Prevention to achieve national goals for
preventing heart disease and stroke. Funding is provided to state health
departments in 32 states and the District of Columbia to support
educational programs, policies, environmental strategies and systems
changes that address heart disease. CDC's WISEWOMAN program funds 15
projects across the country that provides low income, underinsured and
uninsured women (aged 40-64 years) with risk factor screening, lifestyle
intervention strategies and referral services.
For more information about heart disease, please visit the Division of
Heart Disease and Stroke Prevention's Web site at cdc/dhdsp.
Centers for Disease Control and Prevention
cdc/dhdsp
Control and Prevention (CDC) today released a report that finds a wide
range of variation in the prevalence of coronary heart disease (a narrowing
of the arteries that feed the heart), heart attack and angina (chest pain
that occurs when the heart does not get enough blood). The report provides
the first ever information on the percentage of people living with heart
disease in all 50 states and U.S. territories. The report found that some
states and territories had double the prevalence of heart disease as
others. For heart attacks, rates ranged from 2.1 percent in the U.S. Virgin
Islands to 6.1 percent in West Virginia, while the prevalence of any
condition -- heart attack, angina or coronary heart disease -- ranged from
3.5 percent in the U.S. Virgin Islands to 10.4 percent in West Virginia.
The study, Prevalence of Heart Disease - United States, 2005, was
published in today's Morbidity and Mortality Weekly Report. The study is
based on an analysis of state-specific data collected from the Behavioral
Risk Factor Surveillance System -- a random phone survey of U.S. adults age
18 and older conducted by state/territorial health departments.
Overall, about 6.5 percent of those surveyed reported that a doctor or
health care professional had told them they had one or more of the
following - - heart attack, angina or coronary heart disease -- with 4
percent indicating they had a heart attack and 4.4 percent reporting angina
or coronary heart disease. Heart disease is the leading cause of death in
the United States.
"These findings show the importance of preventing and controlling known
risk factors for heart disease, such as high blood cholesterol, tobacco
use, physical inactivity, high blood pressure, type 2 diabetes, and
obesity," said Jonathan Neyer, the study's lead author and an
epidemiologist in CDC's Division for Heart Disease and Stroke Prevention
(DHDSP). "We hope this report will help states and U.S. territories better
tailor their heart disease prevention efforts."
Residents of Alabama, Arizona, Florida, Kentucky, Louisiana, Missouri,
Oklahoma, Tennessee, Texas, and West Virginia had the highest prevalence of
these heart diseases. Many of these states are known to have a high
proportion of residents with multiple heart disease risk factors and a
disproportionately high number of heart disease deaths. The same was found
among residents living in Puerto Rico.
The places reporting the lowest level of heart disease prevalence were:
Nebraska, Wisconsin, Wyoming, New Mexico, Montana, Minnesota, Utah, Hawaii,
Colorado, District of Columbia and the U.S. Virgin Islands.
The report also identified gender and racial/ethnic differences in
heart disease prevalence. Men had a significantly higher prevalence than
women (8.2 percent vs. 5 percent) for coronary heart disease or non-fatal
heart attack, and angina. American Indians/Alaska Natives had the highest
heart disease prevalence (11.2 percent) and Asians had the lowest
prevalence (4.7 percent). There was little difference in heart disease
prevalence among whites (6.9 percent), blacks (6.2 percent) or Hispanics
(6.2 percent).
The report also identified differences in prevalence based on
educational levels. Heart disease prevalence was nearly twice as high in
individuals with fewer than 12 years of education (9.8 percent) compared to
college graduates (5 percent).
CDC works with nearly 80 national organizations through the National
Forum for Heart Disease and Stroke Prevention to achieve national goals for
preventing heart disease and stroke. Funding is provided to state health
departments in 32 states and the District of Columbia to support
educational programs, policies, environmental strategies and systems
changes that address heart disease. CDC's WISEWOMAN program funds 15
projects across the country that provides low income, underinsured and
uninsured women (aged 40-64 years) with risk factor screening, lifestyle
intervention strategies and referral services.
For more information about heart disease, please visit the Division of
Heart Disease and Stroke Prevention's Web site at cdc/dhdsp.
Centers for Disease Control and Prevention
cdc/dhdsp
Merck Receives Not Approvable Letter From FDA For MK-0524A (ER Niacin/laropiprant)
Merck & Co., Inc. received a Not Approvable action letter from the U.S. Food and Drug Administration (FDA) for the Company's New Drug Application (NDA) for MK-0524A (ER niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.
"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A," said Peter S. Kim, Ph. D. executive vice president and president, Merck Research Laboratories.
"We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol. We are encouraged that on April 24, the Committee for Medicinal Products for Human Use (CHMP) recommended marketing approval for MK-0524A in Europe, and we will continue to pursue approval within individual markets in the EU and around the world," added Dr. Kim.
Merck today also reaffirmed the Company's 2008 financial guidance as issued last week (see here) and reiterated Merck's confidence in meeting its goal of double-digit annual EPS growth through 2010 excluding certain items.
"Merck's broad portfolio of medicines and vaccines, including eight products in launch phase, enables us to weather challenges that come our way," said Richard T. Clark, chairman, president and chief executive officer, Merck. "The Company remains confident that we will grow our business this year and achieve the goals outlined in our plan to win."
In the FDA's letter, the agency rejected the proposed trade name CORDAPTIVE for MK-0524A. The Company said at the appropriate time it expects to pursue the alternative trade name TREDAPTIVE for use in the United States.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit merck.
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
merck
"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A," said Peter S. Kim, Ph. D. executive vice president and president, Merck Research Laboratories.
"We firmly believe that MK-0524A provides physicians with an important option to manage their patients' cholesterol. We are encouraged that on April 24, the Committee for Medicinal Products for Human Use (CHMP) recommended marketing approval for MK-0524A in Europe, and we will continue to pursue approval within individual markets in the EU and around the world," added Dr. Kim.
Merck today also reaffirmed the Company's 2008 financial guidance as issued last week (see here) and reiterated Merck's confidence in meeting its goal of double-digit annual EPS growth through 2010 excluding certain items.
"Merck's broad portfolio of medicines and vaccines, including eight products in launch phase, enables us to weather challenges that come our way," said Richard T. Clark, chairman, president and chief executive officer, Merck. "The Company remains confident that we will grow our business this year and achieve the goals outlined in our plan to win."
In the FDA's letter, the agency rejected the proposed trade name CORDAPTIVE for MK-0524A. The Company said at the appropriate time it expects to pursue the alternative trade name TREDAPTIVE for use in the United States.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit merck.
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
merck
ACC Innovation In Intervention: I2 Summit 2006
For the first time, clinical cardiologists will have the opportunity to experience Innovation in Intervention: i2 Summit 2006, the first ACC meeting specifically geared toward interventional cardiologists. Hosting more than 3,000 attendees in its inaugural year from around the world, Innovation in Intervention: i2 Summit will provide in-depth analysis on topics such as percutaneous coronary interventions, best practices for stenting and pioneering methods to improve patient care.
Innovation in Intervention: i2 Summit 2006, which is co-sponsored with the Society for Cardiovascular Angiography and Interventions (SCAI), will be taking place concurrently with ACC.06 at the Georgia World Congress Center on March 11-14. It will provide a forum for interventional cardiology experts to discuss new developments within the field as well as a focused venue to train, educate and guide their international colleagues in intervention and cardiac care. Innovation in Intervention: i2 Summit 2006 is designed specifically for those interested in coronary and peripheral interventions.
Innovation in Intervention: i2 Summit 2006 topics will include:
-- Drug eluting stents and other coronary interventions
-- Peripheral, vascular and non-vascular interventions
-- PCI during AMI and ACS
-- Patient outcomes and quality improvement
-- Pharmacologic therapy for interventional procedures
"Innovation in Intervention: i2 Summit 2006 offers unsurpassed evidence-based content, presented by leaders in interventional cardiology. Live satellite transmissions, computer-based learning and simulation training make the content innovative and interactive," said William O'Neill, M.D., F.A.C.C., i2 Summit Co-Chair.
Attendees of Innovation in Intervention: i2 Summit 2006 will have the opportunity to watch live cases from Europe, Asia and the United States via satellite. Expert simulation demonstrations along with late breaking clinical trials will also be presented.
Press briefings on the late-breaking and regular clinical trials research from both ACC.06 and Innovation in Intervention: i2 Summit 2006 will take place regularly Sunday, March 12 through Tuesday, March 14. For more information, please visit acc or contact Amy Murphy at 301-581-3476 or amurphyacc.
About the American College of Cardiology
The American College of Cardiology (acc) represents the majority of board certified cardiovascular physicians in the United States. Its mission is to advocate for quality cardiovascular care through education, research, promotion, development and application of standards and guidelines- and to influence health care policy. ACC.06 and i2 Summit will bring together more than 30,000 cardiologists and cardiovascular specialists to share the newest discoveries in the treatment and prevention, while helping the ACC achieve its mission to address and improve issues in cardiovascular medicine.
About the Society for Cardiovascular Angiography and Interventions
Headquartered in Bethesda, Md., the Society for Cardiovascular Angiography and Interventions is a 3,400-member professional organization representing invasive and interventional cardiologists. SCAI's mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI was organized in 1976 under the guidance of Drs. F. Mason Sones and Melvin P. Judkins. The first SCAI Annual Scientific Sessions were held in Chicago in 1978. The 29th SCAI Annual Scientific Sessions will be held on May 10-13, 2006 in Chicago.
Amy Murphy
amurphyacc
American College of Cardiology
acc
Innovation in Intervention: i2 Summit 2006, which is co-sponsored with the Society for Cardiovascular Angiography and Interventions (SCAI), will be taking place concurrently with ACC.06 at the Georgia World Congress Center on March 11-14. It will provide a forum for interventional cardiology experts to discuss new developments within the field as well as a focused venue to train, educate and guide their international colleagues in intervention and cardiac care. Innovation in Intervention: i2 Summit 2006 is designed specifically for those interested in coronary and peripheral interventions.
Innovation in Intervention: i2 Summit 2006 topics will include:
-- Drug eluting stents and other coronary interventions
-- Peripheral, vascular and non-vascular interventions
-- PCI during AMI and ACS
-- Patient outcomes and quality improvement
-- Pharmacologic therapy for interventional procedures
"Innovation in Intervention: i2 Summit 2006 offers unsurpassed evidence-based content, presented by leaders in interventional cardiology. Live satellite transmissions, computer-based learning and simulation training make the content innovative and interactive," said William O'Neill, M.D., F.A.C.C., i2 Summit Co-Chair.
Attendees of Innovation in Intervention: i2 Summit 2006 will have the opportunity to watch live cases from Europe, Asia and the United States via satellite. Expert simulation demonstrations along with late breaking clinical trials will also be presented.
Press briefings on the late-breaking and regular clinical trials research from both ACC.06 and Innovation in Intervention: i2 Summit 2006 will take place regularly Sunday, March 12 through Tuesday, March 14. For more information, please visit acc or contact Amy Murphy at 301-581-3476 or amurphyacc.
About the American College of Cardiology
The American College of Cardiology (acc) represents the majority of board certified cardiovascular physicians in the United States. Its mission is to advocate for quality cardiovascular care through education, research, promotion, development and application of standards and guidelines- and to influence health care policy. ACC.06 and i2 Summit will bring together more than 30,000 cardiologists and cardiovascular specialists to share the newest discoveries in the treatment and prevention, while helping the ACC achieve its mission to address and improve issues in cardiovascular medicine.
About the Society for Cardiovascular Angiography and Interventions
Headquartered in Bethesda, Md., the Society for Cardiovascular Angiography and Interventions is a 3,400-member professional organization representing invasive and interventional cardiologists. SCAI's mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI was organized in 1976 under the guidance of Drs. F. Mason Sones and Melvin P. Judkins. The first SCAI Annual Scientific Sessions were held in Chicago in 1978. The 29th SCAI Annual Scientific Sessions will be held on May 10-13, 2006 in Chicago.
Amy Murphy
amurphyacc
American College of Cardiology
acc
How A Statin Drug Reduces Cholesterol And Fat In Blood Vessels
Scientists have provided new details about how a drug used against heart disease helps to unclog blood vessels from an excess of cholesterol and fats. The results help explain how the drug works and may provide ways to improve similar drugs in the future.
A type of white blood cell called macrophage is responsible for the accumulation of fat in blood vessels, leading to inflammation and plaque formation on the inner linings of the vessel. Macrophages produce enzymes called lipases that have been shown to promote fat accumulation in blood vessels. Drugs called statins reduce the accumulation of fat in macrophages but their effects on lipases have not been explored yet.
John S. Hill and colleagues studied the effect of a statin drug called atorvastatin on two lipases, called lipoprotein lipase and endothelial lipase, which break down different types of fats. The researchers showed that the statin significantly reduced the levels of both lipases in macrophages and described in detail the proteins that are affected within the macrophages. These results may help to understand how other statin drugs work and could help design better drugs against heart disease in the future, the scientists conclude.
Article: "Atorvastatin Decreases Lipoprotein Lipase and Endothelial Lipase Expression in Human THP-1 Macrophages," by Guosong Qiu and John S. Hill
The American Society for Biochemistry and Molecular Biology is a nonprofit scientific and educational organization with over 11,900 members in the United States and internationally. Most members teach and conduct research at colleges and universities. Others conduct research in various government laboratories, nonprofit research institutions and industry. The Society's student members attend undergraduate or graduate institutions.
Founded in 1906, the Society is based in Bethesda, Maryland, on the campus of the Federation of American Societies for Experimental Biology. The Society's purpose is to advance the science of biochemistry and molecular biology through publication of the Journal of Biological Chemistry, the Journal of Lipid Research, and Molecular and Cellular Proteomics, organization of scientific meetings, advocacy for funding of basic research and education, support of science education at all levels, and promoting the diversity of individuals entering the scientific work force.
American Society for Biochemistry and Molecular Biology
A type of white blood cell called macrophage is responsible for the accumulation of fat in blood vessels, leading to inflammation and plaque formation on the inner linings of the vessel. Macrophages produce enzymes called lipases that have been shown to promote fat accumulation in blood vessels. Drugs called statins reduce the accumulation of fat in macrophages but their effects on lipases have not been explored yet.
John S. Hill and colleagues studied the effect of a statin drug called atorvastatin on two lipases, called lipoprotein lipase and endothelial lipase, which break down different types of fats. The researchers showed that the statin significantly reduced the levels of both lipases in macrophages and described in detail the proteins that are affected within the macrophages. These results may help to understand how other statin drugs work and could help design better drugs against heart disease in the future, the scientists conclude.
Article: "Atorvastatin Decreases Lipoprotein Lipase and Endothelial Lipase Expression in Human THP-1 Macrophages," by Guosong Qiu and John S. Hill
The American Society for Biochemistry and Molecular Biology is a nonprofit scientific and educational organization with over 11,900 members in the United States and internationally. Most members teach and conduct research at colleges and universities. Others conduct research in various government laboratories, nonprofit research institutions and industry. The Society's student members attend undergraduate or graduate institutions.
Founded in 1906, the Society is based in Bethesda, Maryland, on the campus of the Federation of American Societies for Experimental Biology. The Society's purpose is to advance the science of biochemistry and molecular biology through publication of the Journal of Biological Chemistry, the Journal of Lipid Research, and Molecular and Cellular Proteomics, organization of scientific meetings, advocacy for funding of basic research and education, support of science education at all levels, and promoting the diversity of individuals entering the scientific work force.
American Society for Biochemistry and Molecular Biology
Crestor™ Helps More African Americans with Hypercholesterolaemia Achieve Cholesterol Goals
Results from the ARIES study presented today at the American Heart Association's Annual Scientific Sessions demonstrate
that CRESTOR 10 and 20mg reduce LDL-cholesterol (LDL-C or "bad" cholesterol) significantly more and raise HDL-cholesterol
(HDL-C or "good" cholesterol) more than atorvastatin 10 and 20mg in African Americans with hypercholesterolaemia, and enable
more patients to achieve their US NCEP ATP III guideline LDL-C goals.
Cardiovascular disease (CVD) is estimated to account for approximately a third of all deaths globally and is the leading
cause of mortality in the US. African Americans have higher CVD and stroke death rates than Caucasians, and approximately 40
percent of African American men and women age 20 and older have CVD.
"As an African American physician who treats a large number of African-American patients, the ARIES trial represents an
opportunity to demonstrate the efficacy and safety of statins in this high-risk, undertreated and underserved population,"
said Dr. Keith C. Ferdinand, clinical cardiologist and medical director of Heartbeats Life Center and the lead investigator
for ARIES. "ARIES is the first trial to demonstrate superiority in lowering LDL-cholesterol (bad cholesterol) in this
population using rosuvastatin (CRESTOR) compared to atorvastatin, comparing equal doses of each."
Results from ARIES, involving 774 African American adults with hypercholesterolaemia, show that at six weeks:
-- CRESTOR 10mg reduces LDL-C significantly more than atorvastatin 10mg (-37 percent versus -32 percent, respectively;
p
that CRESTOR 10 and 20mg reduce LDL-cholesterol (LDL-C or "bad" cholesterol) significantly more and raise HDL-cholesterol
(HDL-C or "good" cholesterol) more than atorvastatin 10 and 20mg in African Americans with hypercholesterolaemia, and enable
more patients to achieve their US NCEP ATP III guideline LDL-C goals.
Cardiovascular disease (CVD) is estimated to account for approximately a third of all deaths globally and is the leading
cause of mortality in the US. African Americans have higher CVD and stroke death rates than Caucasians, and approximately 40
percent of African American men and women age 20 and older have CVD.
"As an African American physician who treats a large number of African-American patients, the ARIES trial represents an
opportunity to demonstrate the efficacy and safety of statins in this high-risk, undertreated and underserved population,"
said Dr. Keith C. Ferdinand, clinical cardiologist and medical director of Heartbeats Life Center and the lead investigator
for ARIES. "ARIES is the first trial to demonstrate superiority in lowering LDL-cholesterol (bad cholesterol) in this
population using rosuvastatin (CRESTOR) compared to atorvastatin, comparing equal doses of each."
Results from ARIES, involving 774 African American adults with hypercholesterolaemia, show that at six weeks:
-- CRESTOR 10mg reduces LDL-C significantly more than atorvastatin 10mg (-37 percent versus -32 percent, respectively;
p
Apples Significantly Lower LDL Cholesterol Levels In Older Women
Older women who consume apples everyday were found to have an average of 23% reduced LDL cholesterol levels within six months and a 4% increase in HDL cholesterol, researchers from The Florida State University explained in the Experimental Biology 2011 meeting in Washington, D.C. The authors explain that apples really are a "miracle fruit".
Dr. Bahram H. Arjmandi, PhD, RD, and Professor Margaret A. Sitton write that there is much more to apples than just good fiber. Animal studies have demonstrated that pectin and polyphenols, two substances found in apples, enhance lipid metabolism and reduce the production of molecules that cause inflammation.
They say that theirs is the first study to assess what long-term cardioprotective effects eating apples everyday might have on older (postmenopausal) females.
160 females aged 45-65 years were randomly selected to receive either 75 grams of dried apples daily or dried prunes daily for a whole year. Their blood was examined in a laboratory at months 3, 6 and 12.
Within six months of the study Dr. Arjmandi was surprised. He said:
"Incredible changes in the apple-eating women happened by 6 months- they experienced a 23% decrease in LDL cholesterol (which is known as the "bad cholesterol)."
The apple-consuming women also had reduced levels of lipid hydroperoxide and C-reactive protein.
Dr. Arjmandi added:
"I never expected apple consumption to reduce bad cholesterol to this extent while increasing HDL cholesterol or good cholesterol by about 4%."
Cholesterol travels in the blood and is carried by lipoproteins - lipoproteins are any compound which contain fat (lipid) and proteins. The three main types are:
Low Density Lipoprotein (LDL) - often referred to as bad cholesterol, which carries cholesterol from the liver to cells. If there are excessive amounts of LDL for the cells to use there can be a harmful accumulation of LDL, resulting in a significantly higher risk of developing arterial disease.
High Density Lipoprotein (HDL) - often referred to as good cholesterol. According to experts, HDL prevents arterial disease - it does the opposite of LDL. HDL removes cholesterol from cells and takes it back to the liver, where it is either broken down or expelled from the body.
Triglycerides - chemicals forms in which the majority of fat exists in the body (e.g. blood plasma) and in foods. Triglycerides, in association with cholesterol, form the blood fat (plasma lipids). Calories we eat but do not use up straight away by our tissues turn into triglycerides and are stored in fat cells. When we need energy and have not eaten, our fat cells release triglycerides which are used as energy.
Although the apples added another 240 calories to the women's daily food intake, they did not put any weight on, in fact they lost on average 3.3 pounds.
The authors wrote:
"Reducing body weight is an added benefit to daily apple intake."
Pectin, which is known to help make you feel full, may be a factor in the weight loss, the scientists believe.
The investigators say a multi-investigator nationwide study is needed to confirm their results.
This is one of several studies which back up the expression "an apple a day keeps the doctor away". Dr. Arjmandi is convinced that we all can benefit from consuming apples. He says that two-a-day might be even better.
Dr. Bahram H. Arjmandi, PhD, RD, and Professor Margaret A. Sitton write that there is much more to apples than just good fiber. Animal studies have demonstrated that pectin and polyphenols, two substances found in apples, enhance lipid metabolism and reduce the production of molecules that cause inflammation.
They say that theirs is the first study to assess what long-term cardioprotective effects eating apples everyday might have on older (postmenopausal) females.
160 females aged 45-65 years were randomly selected to receive either 75 grams of dried apples daily or dried prunes daily for a whole year. Their blood was examined in a laboratory at months 3, 6 and 12.
Within six months of the study Dr. Arjmandi was surprised. He said:
"Incredible changes in the apple-eating women happened by 6 months- they experienced a 23% decrease in LDL cholesterol (which is known as the "bad cholesterol)."
The apple-consuming women also had reduced levels of lipid hydroperoxide and C-reactive protein.
Dr. Arjmandi added:
"I never expected apple consumption to reduce bad cholesterol to this extent while increasing HDL cholesterol or good cholesterol by about 4%."
Cholesterol travels in the blood and is carried by lipoproteins - lipoproteins are any compound which contain fat (lipid) and proteins. The three main types are:
Low Density Lipoprotein (LDL) - often referred to as bad cholesterol, which carries cholesterol from the liver to cells. If there are excessive amounts of LDL for the cells to use there can be a harmful accumulation of LDL, resulting in a significantly higher risk of developing arterial disease.
High Density Lipoprotein (HDL) - often referred to as good cholesterol. According to experts, HDL prevents arterial disease - it does the opposite of LDL. HDL removes cholesterol from cells and takes it back to the liver, where it is either broken down or expelled from the body.
Triglycerides - chemicals forms in which the majority of fat exists in the body (e.g. blood plasma) and in foods. Triglycerides, in association with cholesterol, form the blood fat (plasma lipids). Calories we eat but do not use up straight away by our tissues turn into triglycerides and are stored in fat cells. When we need energy and have not eaten, our fat cells release triglycerides which are used as energy.
Although the apples added another 240 calories to the women's daily food intake, they did not put any weight on, in fact they lost on average 3.3 pounds.
The authors wrote:
"Reducing body weight is an added benefit to daily apple intake."
Pectin, which is known to help make you feel full, may be a factor in the weight loss, the scientists believe.
The investigators say a multi-investigator nationwide study is needed to confirm their results.
This is one of several studies which back up the expression "an apple a day keeps the doctor away". Dr. Arjmandi is convinced that we all can benefit from consuming apples. He says that two-a-day might be even better.
Whole-Grain Breakfast Cereal Associated With Reduced Heart Failure Risk
Eating whole-grain breakfast cereals seven or more times per week was associated with a lower risk of heart failure, according to an analysis of the observational Physicians' Health Study. Researchers presented findings of the study at the American Heart Association's 47th Annual Conference on Cardiovascular Disease Epidemiology and Prevention. For the present study, breakfast cereals that contain at least 25 percent oat or bran content were classified as whole grain cereals.
The analysis shows that those who ate a whole-grain breakfast cereal seven or more times per week were less likely (by 28 percent) to develop heart failure over the course of the study than those who never ate such cereal. The risk of heart failure decreased by 22 percent in those who ate a whole-grain breakfast cereal from two to six times per week and by 14 percent in those who ate a whole-grain breakfast cereal up to once per week.
According to researchers, if this data is confirmed by other studies, a healthy diet including whole-grain breakfast cereals along with other measures may help reduce the risk of heart failure.
"There are good and powerful arguments for eating a whole-grain cereal for breakfast," said Luc Djouss?©, M.D., M.P.H., D.Sc., lead author of the study and assistant professor of medicine in the Division of Aging at Brigham & Women's Hospital and Harvard Medical School in Boston, Mass. "The significant health benefits of whole-grain cereal are not just for kids, but also for adults. A whole-grain, high-fiber breakfast may lower blood pressure and bad cholesterol and prevent heart attacks."
Djouss?© urges the general public to consider eating a regular whole-grain, high fiber breakfast for its overall health benefits.
In the Physicians' Health Study, the majority of the physicians in the study ate whole-grain cereals rather than refined cereals. Whole grains are rich in vitamins, minerals, and anti-oxidants and have a high fiber content. Of 10,469 physicians reporting cereal consumption at baseline, 8,266 (79 percent) ate whole-grain cereals compared to 2,203 (21 percent) who ate refined cereals.
Among the physicians who ate whole-grain breakfast cereals, 2,873 (35 percent) said they ate them seven or more times per week; 3,240 (39 percent) said two to six times per week; and 2,153 (26 percent) said they ate up to one cereal serving per week.
The findings reported here were based on annual detailed questionnaires about major heart events and reported breakfast cereal consumption at baseline. However, the results did not change when possible changes in cereal consumption over time (assessed at 18 weeks; two years; four years; six years; eight years; and ten years) were taken into account. Researchers conducted the study from 1982 to 2006. The average age of physicians in the study at baseline was 53.7 years. Djouss?© hopes the findings of the Physicians' Health Study will encourage the general population to eat heart-healthy diets.
"The Physicians' Health Study shows that even in a population with overall healthy behavior, it is possible to see less heart failure in those who eat a whole-grain cereal breakfast," Djouss?© said.
In the United States, foods considered "whole grain" contain 51 percent or more whole grain ingredients by weight per reference amount customarily consumed.
The Physicians' Health Study is supported by grants from the National Cancer Institute and the National Heart, Lung, and Blood Institute, Bethesda, MD. Dr. Djouss?© is principal investigator on a grant from the National Heart, Lung, and Blood Institute, Bethesda, MD.
The study's co-author is J. Michael Gaziano, M.D.
Statements and conclusions of abstract authors that are presented at American Heart Association/American Stroke Association scientific meetings are solely those of the abstract authors and do not necessarily reflect association policy or position. The associations make no representation or warranty as to their accuracy or reliability.
Contact: Karen Astle
American Heart Association
The analysis shows that those who ate a whole-grain breakfast cereal seven or more times per week were less likely (by 28 percent) to develop heart failure over the course of the study than those who never ate such cereal. The risk of heart failure decreased by 22 percent in those who ate a whole-grain breakfast cereal from two to six times per week and by 14 percent in those who ate a whole-grain breakfast cereal up to once per week.
According to researchers, if this data is confirmed by other studies, a healthy diet including whole-grain breakfast cereals along with other measures may help reduce the risk of heart failure.
"There are good and powerful arguments for eating a whole-grain cereal for breakfast," said Luc Djouss?©, M.D., M.P.H., D.Sc., lead author of the study and assistant professor of medicine in the Division of Aging at Brigham & Women's Hospital and Harvard Medical School in Boston, Mass. "The significant health benefits of whole-grain cereal are not just for kids, but also for adults. A whole-grain, high-fiber breakfast may lower blood pressure and bad cholesterol and prevent heart attacks."
Djouss?© urges the general public to consider eating a regular whole-grain, high fiber breakfast for its overall health benefits.
In the Physicians' Health Study, the majority of the physicians in the study ate whole-grain cereals rather than refined cereals. Whole grains are rich in vitamins, minerals, and anti-oxidants and have a high fiber content. Of 10,469 physicians reporting cereal consumption at baseline, 8,266 (79 percent) ate whole-grain cereals compared to 2,203 (21 percent) who ate refined cereals.
Among the physicians who ate whole-grain breakfast cereals, 2,873 (35 percent) said they ate them seven or more times per week; 3,240 (39 percent) said two to six times per week; and 2,153 (26 percent) said they ate up to one cereal serving per week.
The findings reported here were based on annual detailed questionnaires about major heart events and reported breakfast cereal consumption at baseline. However, the results did not change when possible changes in cereal consumption over time (assessed at 18 weeks; two years; four years; six years; eight years; and ten years) were taken into account. Researchers conducted the study from 1982 to 2006. The average age of physicians in the study at baseline was 53.7 years. Djouss?© hopes the findings of the Physicians' Health Study will encourage the general population to eat heart-healthy diets.
"The Physicians' Health Study shows that even in a population with overall healthy behavior, it is possible to see less heart failure in those who eat a whole-grain cereal breakfast," Djouss?© said.
In the United States, foods considered "whole grain" contain 51 percent or more whole grain ingredients by weight per reference amount customarily consumed.
The Physicians' Health Study is supported by grants from the National Cancer Institute and the National Heart, Lung, and Blood Institute, Bethesda, MD. Dr. Djouss?© is principal investigator on a grant from the National Heart, Lung, and Blood Institute, Bethesda, MD.
The study's co-author is J. Michael Gaziano, M.D.
Statements and conclusions of abstract authors that are presented at American Heart Association/American Stroke Association scientific meetings are solely those of the abstract authors and do not necessarily reflect association policy or position. The associations make no representation or warranty as to their accuracy or reliability.
Contact: Karen Astle
American Heart Association
Improving Assessment Of Coronary Heart Disease Risk In Chinese
Scientists report in the November 2007 issue of the Journal of Lipid Research that the concentration of a compound called apolipoprotein B in the blood is better at predicting whether Chinese have coronary heart disease in which fatty deposits clog arteries that supply blood and oxygen to the heart than other substances such as blood cholesterol levels. This finding could help improve the diagnostic and treatment of coronary heart disease in Chinese and maybe in other populations as well.
To diagnose the early stages of coronary heart disease, physicians usually measure levels of substances present in the blood, such as high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol, and apolipoprotein B, which act as "markers" of the disease. But these markers are not very accurate and whether some of them are better at predicting the onset of the disease is not clear yet.
Kuo-Liong Chien, Yuan-Teh Lee and colleagues compared the levels of the markers in over 3,500 participants who did not have the disease at the time of recruitment but some of whom (122 individuals) developed the disease 13 years later. The scientists then compared which of the three substances would have best predicted the onset of the disease and found that the risk of developing coronary heart disease was more than three times as high in participants with the highest values of both apolipoprotein B and the ratio of the total cholesterol over HDL-C than patients who did not have the disease.
The scientists conclude that apolipoprotein B is more strongly associated than LDL-C with the risk of developing coronary heart disease. They add that non-HDL cholesterol is an important predictive factor for CHD among Chinese, more so than LDL cholesterol and that the ratio of total cholesterol over HDL cholesterol can strongly predict coronary heart disease.
Based on these results, the researchers recommend that apolipoprotein B should be included in the comprehensive evaluation of risk for this disease in Asian populations.
Article: "Apoliporotein B and non-high-density lipoprotein cholesterol and risk of coronary heart disease in Chinese," by Kuo-Liong Chien, Hsiu-Ching Hsu, Ta-Chen Su, Ming-Fong Chen, Yuan-Teh Lee, and Frank B. Hu
The American Society for Biochemistry and Molecular Biology is a nonprofit scientific and educational organization with over 11,900 members in the United States and internationally. Most members teach and conduct research at colleges and universities. Others conduct research in various government laboratories, nonprofit research institutions and industry. The Society's student members attend undergraduate or graduate institutions.
Founded in 1906, the Society is based in Bethesda, Maryland, on the campus of the Federation of American Societies for Experimental Biology. The Society's purpose is to advance the science of biochemistry and molecular biology through publication of the Journal of Biological Chemistry, the Journal of Lipid Research, and Molecular and Cellular Proteomics, organization of scientific meetings, advocacy for funding of basic research and education, support of science education at all levels, and promoting the diversity of individuals entering the scientific work force
For more information about ASBMB, see the Society's Web site at asbmb.
American Society for Biochemistry and Molecular Biology (ASBMB)
9650 Rockville Pike
Bethesda, MD 20814-3996
United States
asbmb
To diagnose the early stages of coronary heart disease, physicians usually measure levels of substances present in the blood, such as high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol, and apolipoprotein B, which act as "markers" of the disease. But these markers are not very accurate and whether some of them are better at predicting the onset of the disease is not clear yet.
Kuo-Liong Chien, Yuan-Teh Lee and colleagues compared the levels of the markers in over 3,500 participants who did not have the disease at the time of recruitment but some of whom (122 individuals) developed the disease 13 years later. The scientists then compared which of the three substances would have best predicted the onset of the disease and found that the risk of developing coronary heart disease was more than three times as high in participants with the highest values of both apolipoprotein B and the ratio of the total cholesterol over HDL-C than patients who did not have the disease.
The scientists conclude that apolipoprotein B is more strongly associated than LDL-C with the risk of developing coronary heart disease. They add that non-HDL cholesterol is an important predictive factor for CHD among Chinese, more so than LDL cholesterol and that the ratio of total cholesterol over HDL cholesterol can strongly predict coronary heart disease.
Based on these results, the researchers recommend that apolipoprotein B should be included in the comprehensive evaluation of risk for this disease in Asian populations.
Article: "Apoliporotein B and non-high-density lipoprotein cholesterol and risk of coronary heart disease in Chinese," by Kuo-Liong Chien, Hsiu-Ching Hsu, Ta-Chen Su, Ming-Fong Chen, Yuan-Teh Lee, and Frank B. Hu
The American Society for Biochemistry and Molecular Biology is a nonprofit scientific and educational organization with over 11,900 members in the United States and internationally. Most members teach and conduct research at colleges and universities. Others conduct research in various government laboratories, nonprofit research institutions and industry. The Society's student members attend undergraduate or graduate institutions.
Founded in 1906, the Society is based in Bethesda, Maryland, on the campus of the Federation of American Societies for Experimental Biology. The Society's purpose is to advance the science of biochemistry and molecular biology through publication of the Journal of Biological Chemistry, the Journal of Lipid Research, and Molecular and Cellular Proteomics, organization of scientific meetings, advocacy for funding of basic research and education, support of science education at all levels, and promoting the diversity of individuals entering the scientific work force
For more information about ASBMB, see the Society's Web site at asbmb.
American Society for Biochemistry and Molecular Biology (ASBMB)
9650 Rockville Pike
Bethesda, MD 20814-3996
United States
asbmb
Americans Put Their Health At Risk By Overlooking Underlying Vital Health Measures
The American Society of Anesthesiologists (ASA) released results from the inaugural Vital Health Report, which demonstrate that Americans associate good health with lifestyle behaviors and habits, but overlook their key Vital Health measures (e.g. cholesterol, body mass index, blood pressure, disease screenings), some of the true indicators of overall health. The report further reveals that Americans believe they know more about their Vital Health than they actually do.
"Every day in hospitals and health centers across the country, anesthesiologists see how the Vital Health of patients directly and profoundly affects surgical outcomes and long-term well-being," said John Dombrowski, M.D., American Society of Anesthesiologists. "As the physicians responsible for safeguarding the health of patients when it matters most, we are urging all Americans to improve their Vital Health by monitoring Vital Health measures, which play a key role in their overall wellness and positive medical outcomes."
The Vital Health Report is based on a survey of over 1,000 Americans that examined their knowledge, attitudes, awareness and behaviors associated with health and wellness. Vital Health is defined as how effectively a person maintains a healthy lifestyle, including the monitoring of his or her vital measures, and how that impacts wellness and positive medical outcomes. Key findings from the survey include:
Vital Health Measures Are Overlooked
While respondents overwhelmingly associate good health with daily habits, they overlook underlying Vital Health measures (such as cholesterol, body mass index, blood pressure and disease screenings) that are some of the key indicators of Vital Health.
- Nearly half of respondents most associate Vital Health with healthy behaviors while only 27 percent associate it with blood pressure. Less than 15 percent associate Vital Health with such key measures as heart rate, cholesterol level and respiration. More than one-third of respondents only "sometimes" ask their physicians for specific medical results, while 7 percent never ask.
- Nearly 70 percent of respondents say they had their cholesterol checked this past year, but one-third of them don't know their actual cholesterol level. Almost 40 percent of those 18-35 years old say they have never had their cholesterol checked.
- Half of respondents don't know their body mass index.
Vital Health Is Not Protected
There is a gap between what people know they should do and what they actually do to protect their Vital Health.
- Respondents believe that exercising at least three times each week has the most positive effect on Vital Health, but only slightly more than half say they consistently work out.
- Furthermore, they rank maintaining a healthy diet as the second most important factor, yet less than half say that they actually do this.
Personal Health Perceptions Vary Widely by Demographic Group
Respondents over the age of 65, as well as those within high-income households, more frequently evaluate themselves as healthy.
- One out of 10 respondents over the age of 65 say they believe they are "extremely healthy," while only 4 percent of 35-49 year-olds say they believe they are.
- On average, 82 percent of respondents within high-income households ($125,000+) say they believe they are healthy compared to 71 percent of respondents who earn less.
"When patients have surgery, it is a vulnerable time for them, physically, emotionally and sometimes financially," said Peter Pronovost, M.D., Ph.D., ASA member and author of Safe Patients, Smart Hospitals. "Yet, some simple personal health measures, such as whether you smoke or have high blood pressure, strongly predict the level of risk for complications that you will have going through surgery. The American Society of Anesthesiologists' new program, Vital Health, helps patients assess and hopefully minimize these risks, ensuring that patients thrive when they have surgery."
An Opportunity to Improve Your Vital Health
The ASA encourages Americans to take the first step toward improving their Vital Health by going to KnowYourVitalHealth and using the Know Your Vital Health Tool. After answering a series of health-related questions, patients will receive a customized, anonymous report of health and wellness information and suggestions.
Please visit LifelinetoModernMedicine for more information about the Vital Health Report and to use the Know Your Vital Health Tool.
The inaugural Vital Health Report is the first in a series of surveys that will be conducted throughout 2010.
Methodology
The Vital Health survey was administered online February 8-11, 2010 to 1,032 Americans split evenly between men and women and ranging in age from 18 to 75+ years. The survey consisted of 33 questions.
Source
American Society of Anesthesiologists
"Every day in hospitals and health centers across the country, anesthesiologists see how the Vital Health of patients directly and profoundly affects surgical outcomes and long-term well-being," said John Dombrowski, M.D., American Society of Anesthesiologists. "As the physicians responsible for safeguarding the health of patients when it matters most, we are urging all Americans to improve their Vital Health by monitoring Vital Health measures, which play a key role in their overall wellness and positive medical outcomes."
The Vital Health Report is based on a survey of over 1,000 Americans that examined their knowledge, attitudes, awareness and behaviors associated with health and wellness. Vital Health is defined as how effectively a person maintains a healthy lifestyle, including the monitoring of his or her vital measures, and how that impacts wellness and positive medical outcomes. Key findings from the survey include:
Vital Health Measures Are Overlooked
While respondents overwhelmingly associate good health with daily habits, they overlook underlying Vital Health measures (such as cholesterol, body mass index, blood pressure and disease screenings) that are some of the key indicators of Vital Health.
- Nearly half of respondents most associate Vital Health with healthy behaviors while only 27 percent associate it with blood pressure. Less than 15 percent associate Vital Health with such key measures as heart rate, cholesterol level and respiration. More than one-third of respondents only "sometimes" ask their physicians for specific medical results, while 7 percent never ask.
- Nearly 70 percent of respondents say they had their cholesterol checked this past year, but one-third of them don't know their actual cholesterol level. Almost 40 percent of those 18-35 years old say they have never had their cholesterol checked.
- Half of respondents don't know their body mass index.
Vital Health Is Not Protected
There is a gap between what people know they should do and what they actually do to protect their Vital Health.
- Respondents believe that exercising at least three times each week has the most positive effect on Vital Health, but only slightly more than half say they consistently work out.
- Furthermore, they rank maintaining a healthy diet as the second most important factor, yet less than half say that they actually do this.
Personal Health Perceptions Vary Widely by Demographic Group
Respondents over the age of 65, as well as those within high-income households, more frequently evaluate themselves as healthy.
- One out of 10 respondents over the age of 65 say they believe they are "extremely healthy," while only 4 percent of 35-49 year-olds say they believe they are.
- On average, 82 percent of respondents within high-income households ($125,000+) say they believe they are healthy compared to 71 percent of respondents who earn less.
"When patients have surgery, it is a vulnerable time for them, physically, emotionally and sometimes financially," said Peter Pronovost, M.D., Ph.D., ASA member and author of Safe Patients, Smart Hospitals. "Yet, some simple personal health measures, such as whether you smoke or have high blood pressure, strongly predict the level of risk for complications that you will have going through surgery. The American Society of Anesthesiologists' new program, Vital Health, helps patients assess and hopefully minimize these risks, ensuring that patients thrive when they have surgery."
An Opportunity to Improve Your Vital Health
The ASA encourages Americans to take the first step toward improving their Vital Health by going to KnowYourVitalHealth and using the Know Your Vital Health Tool. After answering a series of health-related questions, patients will receive a customized, anonymous report of health and wellness information and suggestions.
Please visit LifelinetoModernMedicine for more information about the Vital Health Report and to use the Know Your Vital Health Tool.
The inaugural Vital Health Report is the first in a series of surveys that will be conducted throughout 2010.
Methodology
The Vital Health survey was administered online February 8-11, 2010 to 1,032 Americans split evenly between men and women and ranging in age from 18 to 75+ years. The survey consisted of 33 questions.
Source
American Society of Anesthesiologists
McGill researchers identify new way to reduce cholesterol levels
Just in time for the holidays, McGill researchers have identified a new way to reduce fat and cholesterol levels in the
body. Their program, which combines consuming plant-derived sterols (or oils) with exercise, may benefit those who are at
risk of coronary heart disease. These findings were recently published in the American Journal of Clinical Nutrition.
"Both consuming plant sterols and exercising have been shown to affect blood cholesterol levels on their own," said senior
author McGill Professor of dietetics and nutrition, Peter Jones. "Our research is the first to look at the complementary
combined effects of these therapies."
Seventy-four non-active individuals between the ages of 40 and 70 were recruited for the study. They were placed into the
following four different intervention groups: combination (consumed margarine containing plant sterols and exercised),
exercise (consumed plant-sterol -free margarine and exercised), sterol only (consumed margarine containing plant sterols and
did not exercise) and control (consumed plant-sterol free margarine and did not exercise). Exercise involved using
stair-stepping machines and stationary bicycles three times a week. Margarine was consumed four times a day. This regimen was
continued for eight weeks, blood samples were taken and lipid analysis was performed.
"In comparison with plant sterols or exercise alone, the combination of plant sterols and exercise yielded the most
beneficial change in the volunteer's cholesterol and lipid levels," said lead author and McGill doctoral student, Krista
Varady. "This combination therapy favourably altered their lipid profiles by decreasing total cholesterol, low-density
lipoprotein (LDL) cholesterol, and triacylglycerol levels and by increasing high-density lipoprotein (HDL) cholesterol
levels."
"These findings suggest that combination therapy may improve the cholesterol and lipid levels in previously sedentary adults
who have high cholesterol. Furthermore this therapy may reduce the risk of coronary artery disease for these individuals."
Jones added that there were other benefits associated with the exercise program. "Our volunteers were typically inactive. In
addition to the altered cholesterol levels, the increased physical activity contributed to loss of weight and improved
motivation. Long term exercise can also reduce blood pressure and reduce the risk of other health complications."
"These findings on the combination of plant sterols - which are also naturally present in nuts, seeds, legumes, vegetable
oils, and other plant sources - and exercise are very interesting," says Dr. Jacques Genest, spokesperson for the Heart and
Stroke Foundation. "The Heart and Stroke Foundation supports this research to find ways to reduce high blood cholesterol, a
significant risk factor for heart disease and stroke."
This research was supported by funding from the Heart and Stroke Foundation.
About McGill University
McGill University is Canada's leading research-intensive university and has earned an international reputation for scholarly
achievement and scientific discovery. Founded in 1821, McGill has 21 faculties and professional schools which offer more than
300 programs from the undergraduate to the doctoral level. McGill attracts renowned professors and researchers from around
the world and top students from more than 150 countries, creating one of the most dynamic and diverse education environments
in North America. There are approximately 23,000 undergraduate students and 7,000 graduate students. It is one of two
Canadian members of the American Association of Universities. McGill's two campuses are located in Montreal, Canada.
About the Heart and Stroke Foundation
The Heart and Stroke Foundation (heartandstroke.ca) is
a leading funder of heart and stroke research in Canada. The Foundation's mission is to improve the health of Canadians by
preventing and reducing disability and death from heart disease and stroke through research, health promotion and advocacy.
Contact: Christine Zeindler
christine.zeindlermcgill.ca
514-398-6754
McGill University
body. Their program, which combines consuming plant-derived sterols (or oils) with exercise, may benefit those who are at
risk of coronary heart disease. These findings were recently published in the American Journal of Clinical Nutrition.
"Both consuming plant sterols and exercising have been shown to affect blood cholesterol levels on their own," said senior
author McGill Professor of dietetics and nutrition, Peter Jones. "Our research is the first to look at the complementary
combined effects of these therapies."
Seventy-four non-active individuals between the ages of 40 and 70 were recruited for the study. They were placed into the
following four different intervention groups: combination (consumed margarine containing plant sterols and exercised),
exercise (consumed plant-sterol -free margarine and exercised), sterol only (consumed margarine containing plant sterols and
did not exercise) and control (consumed plant-sterol free margarine and did not exercise). Exercise involved using
stair-stepping machines and stationary bicycles three times a week. Margarine was consumed four times a day. This regimen was
continued for eight weeks, blood samples were taken and lipid analysis was performed.
"In comparison with plant sterols or exercise alone, the combination of plant sterols and exercise yielded the most
beneficial change in the volunteer's cholesterol and lipid levels," said lead author and McGill doctoral student, Krista
Varady. "This combination therapy favourably altered their lipid profiles by decreasing total cholesterol, low-density
lipoprotein (LDL) cholesterol, and triacylglycerol levels and by increasing high-density lipoprotein (HDL) cholesterol
levels."
"These findings suggest that combination therapy may improve the cholesterol and lipid levels in previously sedentary adults
who have high cholesterol. Furthermore this therapy may reduce the risk of coronary artery disease for these individuals."
Jones added that there were other benefits associated with the exercise program. "Our volunteers were typically inactive. In
addition to the altered cholesterol levels, the increased physical activity contributed to loss of weight and improved
motivation. Long term exercise can also reduce blood pressure and reduce the risk of other health complications."
"These findings on the combination of plant sterols - which are also naturally present in nuts, seeds, legumes, vegetable
oils, and other plant sources - and exercise are very interesting," says Dr. Jacques Genest, spokesperson for the Heart and
Stroke Foundation. "The Heart and Stroke Foundation supports this research to find ways to reduce high blood cholesterol, a
significant risk factor for heart disease and stroke."
This research was supported by funding from the Heart and Stroke Foundation.
About McGill University
McGill University is Canada's leading research-intensive university and has earned an international reputation for scholarly
achievement and scientific discovery. Founded in 1821, McGill has 21 faculties and professional schools which offer more than
300 programs from the undergraduate to the doctoral level. McGill attracts renowned professors and researchers from around
the world and top students from more than 150 countries, creating one of the most dynamic and diverse education environments
in North America. There are approximately 23,000 undergraduate students and 7,000 graduate students. It is one of two
Canadian members of the American Association of Universities. McGill's two campuses are located in Montreal, Canada.
About the Heart and Stroke Foundation
The Heart and Stroke Foundation (heartandstroke.ca) is
a leading funder of heart and stroke research in Canada. The Foundation's mission is to improve the health of Canadians by
preventing and reducing disability and death from heart disease and stroke through research, health promotion and advocacy.
Contact: Christine Zeindler
christine.zeindlermcgill.ca
514-398-6754
McGill University
Crestor Safe and Effective When Used According to Prescribing Information
Conclusions from a review published in Circulation today regarding CRESTOR are misleading, and unfortunately create
unnecessary alarm for patients who need this medication to lower their cholesterol.
Conclusions from the Circulation review, based on adverse event reporting system (AERS) data gathered through September 2004,
stand in direct contrast to an FDA document issued on March 14, 2005, in response to a citizen's petition.
A copy of the FDA's document can be found at: fda/cder/drug/infopage/rosuvastatin/crestor_CP.pdf
The FDA has access to the most complete data set and according to their conclusion, "[o]ur review of all of the available
evidence (including preclinical data, pre-marketing clinical studies, Phase 4 clinical studies, and post-marketing adverse
event reports) indicates that CRESTOR does not pose a risk of muscle toxicity greater than the other approved statins, and
that with respect to renal toxicity, there is no convincing evidence that CRESTOR poses a risk of serious renal injury."
The Circulation report attempts to draw conclusions that simply can not be drawn from adverse event reporting data. The
FDA's own disclaimer on the front page of the AERS states, "the information contained in these [adverse event] reports has
not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the
incidence of adverse drug reactions."
It is important to note that the results of this study represent the conclusions of the authors only and do not represent the
official position of the AHA.
CRESTOR has been prescribed almost 22 million times for more than 4.7 million patients. AstraZeneca stands fully behind the
safety and effectiveness of CRESTOR when the product is used according to the prescribing information.
About CRESTOR
CRESTOR (rosuvastatin
calcium) is a once-daily prescription medication for use as an adjunct to diet in the treatment of various lipid
disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. It is a member of
the statin (HMG-CoA reductase inhibitors) class of drug therapy. CRESTOR has not been determined to prevent heart disease,
heart attacks, or strokes. For patients with hypercholesterolemia and mixed dyslipidemia, the usual recommended starting dose
of CRESTOR is 10 mg. Initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive
LDL-C reductions or who have predisposing factors for myopathy. For patients with marked hypercholesterolemia (LDL-C >190
mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered. AstraZeneca licensed worldwide rights to
CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.
Important Safety Information
CRESTOR is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases,
in women who are pregnant or may become pregnant, and in nursing mothers. It is recommended that liver function tests be
performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g.,
semiannually) thereafter. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported
with CRESTOR and with other drugs in this class. The 40-mg dose of CRESTOR is reserved for those patients who have not
achieved LDL-C goal at 20 mg. CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy,
such as renal impairment. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness,
particularly if accompanied by malaise or fever.
CRESTOR is generally well-tolerated. Adverse reactions have usually been mild and transient. The most frequent adverse
events thought to be related to CRESTOR were myalgia (3.3%), constipation (1.4%), asthenia (1.3%), abdominal pain (1.3%) and
nausea (1.3%).
A full copy of the prescribing information for CRESTOR is available at astrazeneca-us/pi/crestor.pdf or by calling 1-877-420-7249.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of
prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies
with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory,
oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than
12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For
more information about AstraZeneca, please visit: astrazeneca-us
View drug information on Crestor.
unnecessary alarm for patients who need this medication to lower their cholesterol.
Conclusions from the Circulation review, based on adverse event reporting system (AERS) data gathered through September 2004,
stand in direct contrast to an FDA document issued on March 14, 2005, in response to a citizen's petition.
A copy of the FDA's document can be found at: fda/cder/drug/infopage/rosuvastatin/crestor_CP.pdf
The FDA has access to the most complete data set and according to their conclusion, "[o]ur review of all of the available
evidence (including preclinical data, pre-marketing clinical studies, Phase 4 clinical studies, and post-marketing adverse
event reports) indicates that CRESTOR does not pose a risk of muscle toxicity greater than the other approved statins, and
that with respect to renal toxicity, there is no convincing evidence that CRESTOR poses a risk of serious renal injury."
The Circulation report attempts to draw conclusions that simply can not be drawn from adverse event reporting data. The
FDA's own disclaimer on the front page of the AERS states, "the information contained in these [adverse event] reports has
not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the
incidence of adverse drug reactions."
It is important to note that the results of this study represent the conclusions of the authors only and do not represent the
official position of the AHA.
CRESTOR has been prescribed almost 22 million times for more than 4.7 million patients. AstraZeneca stands fully behind the
safety and effectiveness of CRESTOR when the product is used according to the prescribing information.
About CRESTOR
CRESTOR (rosuvastatin
calcium) is a once-daily prescription medication for use as an adjunct to diet in the treatment of various lipid
disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. It is a member of
the statin (HMG-CoA reductase inhibitors) class of drug therapy. CRESTOR has not been determined to prevent heart disease,
heart attacks, or strokes. For patients with hypercholesterolemia and mixed dyslipidemia, the usual recommended starting dose
of CRESTOR is 10 mg. Initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive
LDL-C reductions or who have predisposing factors for myopathy. For patients with marked hypercholesterolemia (LDL-C >190
mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered. AstraZeneca licensed worldwide rights to
CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.
Important Safety Information
CRESTOR is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases,
in women who are pregnant or may become pregnant, and in nursing mothers. It is recommended that liver function tests be
performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g.,
semiannually) thereafter. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported
with CRESTOR and with other drugs in this class. The 40-mg dose of CRESTOR is reserved for those patients who have not
achieved LDL-C goal at 20 mg. CRESTOR should be prescribed with caution in patients with predisposing factors for myopathy,
such as renal impairment. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness,
particularly if accompanied by malaise or fever.
CRESTOR is generally well-tolerated. Adverse reactions have usually been mild and transient. The most frequent adverse
events thought to be related to CRESTOR were myalgia (3.3%), constipation (1.4%), asthenia (1.3%), abdominal pain (1.3%) and
nausea (1.3%).
A full copy of the prescribing information for CRESTOR is available at astrazeneca-us/pi/crestor.pdf or by calling 1-877-420-7249.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of
prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies
with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory,
oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than
12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For
more information about AstraZeneca, please visit: astrazeneca-us
View drug information on Crestor.
Prescriptions Highlight Healthcare Inequalities
Statin prescription varies across geographic locations in Australia, according to a study in The Australian Journal of Rural Health by published Wiley-Blackwell.
This difference in statin prescribing not only demonstrates inequalities in healthcare due to geography, it also suggests that the accessibility of health services may a key factor determining its usage.
Statin is used globally to lower cholesterol levels, thereby reducing the risk of coronary heart disease (CHD). In 2005, Australia spent 945 million, or approximately 16 per cent of the Pharmaceutical Benefits Scheme (PBS) budget on statins alone.
The study entitled "Gender, socioeconomic status, need or access? Differences in statin prescribing across urban, rural and remote Australia" used PBS data on statin prescribing to demonstrate that statin prescribing varies by geographic location, with rates decreasing as the population moves from the urban to rural and remote areas. This trend remains constant even with adjustments for age, gender and socioeconomic status.
Co-author Professor Nigel Stocks from the University of Adelaide said, "There has been well recognized shortage of general practitioners in rural and remote areas. If people are unable to get an appointment with their GP, they may not receive the optimal preventive care needed - the prescription of statins for the primary and secondary prevention of CHD might very well be reflective of this issue."
He adds, "More research should be done to confirm that access to health services affects statin use, both in Australia and overseas. We must determine how individuals and groups at high risk of CHD disease in the community can be provided with the appropriate medical services."
Wiley - Blackwell
interscience.wiley
This difference in statin prescribing not only demonstrates inequalities in healthcare due to geography, it also suggests that the accessibility of health services may a key factor determining its usage.
Statin is used globally to lower cholesterol levels, thereby reducing the risk of coronary heart disease (CHD). In 2005, Australia spent 945 million, or approximately 16 per cent of the Pharmaceutical Benefits Scheme (PBS) budget on statins alone.
The study entitled "Gender, socioeconomic status, need or access? Differences in statin prescribing across urban, rural and remote Australia" used PBS data on statin prescribing to demonstrate that statin prescribing varies by geographic location, with rates decreasing as the population moves from the urban to rural and remote areas. This trend remains constant even with adjustments for age, gender and socioeconomic status.
Co-author Professor Nigel Stocks from the University of Adelaide said, "There has been well recognized shortage of general practitioners in rural and remote areas. If people are unable to get an appointment with their GP, they may not receive the optimal preventive care needed - the prescription of statins for the primary and secondary prevention of CHD might very well be reflective of this issue."
He adds, "More research should be done to confirm that access to health services affects statin use, both in Australia and overseas. We must determine how individuals and groups at high risk of CHD disease in the community can be provided with the appropriate medical services."
Wiley - Blackwell
interscience.wiley
Statins Reduce Risk Of Alzheimer's Disease According To New Long-Term Prospective Study
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) holds U.S. and global patent rights for the use of statin drugs for the prevention and treatment of Alzheimer's disease (AD), including for patients at risk for AD because of vascular-related risk factors or disease. An important new study has found that ongoing statin drug use was associated with a 67% reduction in the risk of AD (Current Alzheimer Research 2008; 5: 416-421). The authors concluded that the "data suggest that statins produce a significant reduction in the risk of AD."
In the study, 2,233 people aged 70 years or older from six U.S. centers were followed for 4 years with annual assessments of cognitive changes. Subjects with suspected cognitive decline were referred for an in-depth evaluation for dementia and AD diagnosis. The study also tracked the use of statin and other cholesterol-lowering agents. Subjects who were taking statin drugs were found to have a statistically significant 67% reduction in the risk of AD.
The study authors also reviewed the other published studies assessing the effect of statin use on later risk of AD in the elderly and noted that 13 out of 15 of these studies had reported reduced risk for AD associated with cholesterol-lowering therapy. They concluded: "Overall, the evidence, with limited exceptions, suggests that statin therapy provides some level of benefit in treating individuals with AD, and prior statin use may reduce the risk of AD later in life."
Statins are widely used cholesterol-lowering drugs with a well-established track record of safety. They have an estimated global market over $25 billion and represent a potential new way of treating or preventing AD. Statin drug use has been shown to be associated with a lower risk of neuropathological changes in the brain of AD (Neurology 2007;69;878-885). AD is the leading cause of dementia in the elderly, afflicting an estimated 4.5 million people in the U.S.
This press release contains certain "forward-looking statements" as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management's current expectations. The conduct of clinical trials and the development of drug products involve substantial risks and uncertainties and actual results may differ materially from expectations. Promising early results do not ensure that later stage or larger scale clinical trials will be successful or will proceed as expected. Such factors are detailed from time to time in Nymox's filings with the United States Securities and Exchange Commission and other regulatory authorities.
Source
Roy Wolvin
Nymox Pharmaceutical Corporation
In the study, 2,233 people aged 70 years or older from six U.S. centers were followed for 4 years with annual assessments of cognitive changes. Subjects with suspected cognitive decline were referred for an in-depth evaluation for dementia and AD diagnosis. The study also tracked the use of statin and other cholesterol-lowering agents. Subjects who were taking statin drugs were found to have a statistically significant 67% reduction in the risk of AD.
The study authors also reviewed the other published studies assessing the effect of statin use on later risk of AD in the elderly and noted that 13 out of 15 of these studies had reported reduced risk for AD associated with cholesterol-lowering therapy. They concluded: "Overall, the evidence, with limited exceptions, suggests that statin therapy provides some level of benefit in treating individuals with AD, and prior statin use may reduce the risk of AD later in life."
Statins are widely used cholesterol-lowering drugs with a well-established track record of safety. They have an estimated global market over $25 billion and represent a potential new way of treating or preventing AD. Statin drug use has been shown to be associated with a lower risk of neuropathological changes in the brain of AD (Neurology 2007;69;878-885). AD is the leading cause of dementia in the elderly, afflicting an estimated 4.5 million people in the U.S.
This press release contains certain "forward-looking statements" as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management's current expectations. The conduct of clinical trials and the development of drug products involve substantial risks and uncertainties and actual results may differ materially from expectations. Promising early results do not ensure that later stage or larger scale clinical trials will be successful or will proceed as expected. Such factors are detailed from time to time in Nymox's filings with the United States Securities and Exchange Commission and other regulatory authorities.
Source
Roy Wolvin
Nymox Pharmaceutical Corporation
Biospherics Acquires Global Patent Rights From University Of Kentucky Research Foundation To Develop Tagatose As A Trigylcerides Therapy
Spherix Incorporated (Nasdaq: SPEX), an innovator in biotechnology for therapy in diabetes, metabolic syndrome, and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, announced that its wholly-owned subsidiary, Biospherics Incorporated, has signed a license agreement with the University of Kentucky Research Foundation (UKRF). The agreement gives Biospherics the worldwide rights to international patents filed on behalf of UKRF for Dtagatose as a lipid-lowering agent for prevention and treatment of atherosclerosis, hypertriglyceridemia, and related dyslipidemias.
Also included in the license are five unique drug formulations that include Dtagatose as one of the active pharmaceutical ingredients for treatment of atherosclerosis and the metabolic syndrome. The international patent applications are filed under the PCT (Patent Cooperation Treaty). A majority of the world's countries are signatories to the PCT, including all of the major industrialized countries (with a few exceptions such as Argentina and Taiwan). As of September 28, 2009, there were 142 contracting states to the PCT.
"Spherix believes that D-tagatose has good potential as a treatment for the underserved triglyceride market," said Dr. Claire Kruger, CEO of Spherix. "Preliminary results from our single-blinded Phase 2 clinical trial in diabetes show that low doses of D-tagatose significantly lowered triglyceride levels in people with only mildly elevated triglyceride levels. We are confident that clinical trials dedicated to evaluating D-tagatose in patients with moderately or highly elevated triglycerides will replicate or even improve on those results."
"Assuming a similar reduction in triglycerides is seen in our Phase 3 clinical study in diabetes, from which data will be revealed later this summer, we look forward to developing a second, uniquely-different product for the marketplace," said Dr. Kruger.
About Triglycerides
Triglycerides are one of the fats found in blood. The body converts any calories that are not immediately used into triglycerides and stores them in fat cells. The calories are either released by the liver and circulate in VLDL or are metabolized by fat and released as fatty acids. Between meals, when the body needs energy, hormones release the stored triglycerides from fat cells as free fatty acids for energy. In contrast, cholesterol, another type of fat found in the bloodstream, is used by the body to build cells and some types of hormones.
Scientists aren't exactly sure of the role that triglyceride plays in heart disease. However, they think it contributes to hardening of the arteries, which contributes to stroke, heart disease and heart attacks. High triglyceride levels are sometimes a symptom of conditions associated with heart disease such as obesity and metabolic syndrome, which is a condition associated with elevated glucose levels as well as too much fat around the waist, high blood pressure, high triglycerides and low HDL cholesterol.
About International Patents and the Patent Cooperation Treaty
Under the PCT, a single filing of an international application is made with a Receiving Office (RO) in one language. That filing results in a search performed by an International Searching Authority (ISA), accompanied by a written opinion regarding the patentability of the invention, which is the subject of the application. The search is optionally followed by a preliminary examination, performed by an International Preliminary Examining Authority (IPEA). Finally, the relevant individual national or regional authorities administer matters related to the examination of application (if provided by national law) and issuance of the patent.
About D-tagatose
D-tagatose is a novel and natural oral agent that does not stimulate insulin secretion, and naturally lowers blood glucose levels. D-tagatose has an established safety profile as an artificial sweetener and has been recognized by the FDA as a GRAS (Generally Recognized As Safe) substance for use in food and beverages since 2001. Spherix has intellectual property protecting D-tagatose, with two U.S. patents and one patent pending.
About Spherix
Spherix Incorporated was launched in 1967 as a scientific research company, under the name Biospherics Research. The company now leverages its scientific and technical expertise and experience through its two subsidiaries -- Biospherics Incorporated and Spherix Consulting, Inc. The Spherix Consulting provides scientific and strategic support for suppliers, manufacturers, distributors and retailers of conventional foods, biotechnology-derived foods, medical foods, infant formulas, food ingredients, dietary supplements, food contact substances, pharmaceuticals, medical devices, consumer products, and industrial chemicals and pesticides.
Forward-Looking Statements
This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or my be successfully marketed or manufactured, we may lack financial resources to complete development of D-tagatose, the FDA may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our continuing efforts to develop D-tagatose may be unsuccessful, our common stock could be delisted from the Nasdaq Capital Market, and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission, including our current report on Form 8-K filed on October 10, 2007. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.
Also included in the license are five unique drug formulations that include Dtagatose as one of the active pharmaceutical ingredients for treatment of atherosclerosis and the metabolic syndrome. The international patent applications are filed under the PCT (Patent Cooperation Treaty). A majority of the world's countries are signatories to the PCT, including all of the major industrialized countries (with a few exceptions such as Argentina and Taiwan). As of September 28, 2009, there were 142 contracting states to the PCT.
"Spherix believes that D-tagatose has good potential as a treatment for the underserved triglyceride market," said Dr. Claire Kruger, CEO of Spherix. "Preliminary results from our single-blinded Phase 2 clinical trial in diabetes show that low doses of D-tagatose significantly lowered triglyceride levels in people with only mildly elevated triglyceride levels. We are confident that clinical trials dedicated to evaluating D-tagatose in patients with moderately or highly elevated triglycerides will replicate or even improve on those results."
"Assuming a similar reduction in triglycerides is seen in our Phase 3 clinical study in diabetes, from which data will be revealed later this summer, we look forward to developing a second, uniquely-different product for the marketplace," said Dr. Kruger.
About Triglycerides
Triglycerides are one of the fats found in blood. The body converts any calories that are not immediately used into triglycerides and stores them in fat cells. The calories are either released by the liver and circulate in VLDL or are metabolized by fat and released as fatty acids. Between meals, when the body needs energy, hormones release the stored triglycerides from fat cells as free fatty acids for energy. In contrast, cholesterol, another type of fat found in the bloodstream, is used by the body to build cells and some types of hormones.
Scientists aren't exactly sure of the role that triglyceride plays in heart disease. However, they think it contributes to hardening of the arteries, which contributes to stroke, heart disease and heart attacks. High triglyceride levels are sometimes a symptom of conditions associated with heart disease such as obesity and metabolic syndrome, which is a condition associated with elevated glucose levels as well as too much fat around the waist, high blood pressure, high triglycerides and low HDL cholesterol.
About International Patents and the Patent Cooperation Treaty
Under the PCT, a single filing of an international application is made with a Receiving Office (RO) in one language. That filing results in a search performed by an International Searching Authority (ISA), accompanied by a written opinion regarding the patentability of the invention, which is the subject of the application. The search is optionally followed by a preliminary examination, performed by an International Preliminary Examining Authority (IPEA). Finally, the relevant individual national or regional authorities administer matters related to the examination of application (if provided by national law) and issuance of the patent.
About D-tagatose
D-tagatose is a novel and natural oral agent that does not stimulate insulin secretion, and naturally lowers blood glucose levels. D-tagatose has an established safety profile as an artificial sweetener and has been recognized by the FDA as a GRAS (Generally Recognized As Safe) substance for use in food and beverages since 2001. Spherix has intellectual property protecting D-tagatose, with two U.S. patents and one patent pending.
About Spherix
Spherix Incorporated was launched in 1967 as a scientific research company, under the name Biospherics Research. The company now leverages its scientific and technical expertise and experience through its two subsidiaries -- Biospherics Incorporated and Spherix Consulting, Inc. The Spherix Consulting provides scientific and strategic support for suppliers, manufacturers, distributors and retailers of conventional foods, biotechnology-derived foods, medical foods, infant formulas, food ingredients, dietary supplements, food contact substances, pharmaceuticals, medical devices, consumer products, and industrial chemicals and pesticides.
Forward-Looking Statements
This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or my be successfully marketed or manufactured, we may lack financial resources to complete development of D-tagatose, the FDA may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our continuing efforts to develop D-tagatose may be unsuccessful, our common stock could be delisted from the Nasdaq Capital Market, and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission, including our current report on Form 8-K filed on October 10, 2007. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.
Patients Who Discontinue Statin Therapy May Be More Likely To Die, New Observational Study Shows
The results of a new observational study presented recently at the showed that patients who stop taking their prescribed statins have a four-fold increased risk of death during the first year following an acute coronary syndrome.
The study included 2,234 patients who were prescribed statin therapy after an acute coronary syndrome. Patients were followed for one year after discharge from the hospital. For those who discontinued their therapy, median time to discontinuation was 35 days.
"Patients who have survived one acute coronary event are at an increased risk for additional cardiovascular events such as a heart attack or stroke" said Professor Furio Colivicchi, study author and Director, Clinical Quality Management Unit at the Cardiovascular Department, San Filippo Neri Hospital, Rome, Italy. "The vast majority of this high-risk patient population is expected to benefit significantly from long-term statin therapy. Yet many of these patients quickly stop taking their prescribed statins. This study shows how dangerous that decision can be, since it increases their chance of death."
"Discontinuation of medication is common in clinical practice," Dr. Colivicchi continued. "This study tells us that patient care needs to be improved as patients are transitioned from a hospital setting to outpatient care, where medication persistence is often overlooked. Physicians need to keep their patients informed of critical information such as the potentially deadly consequences of foregoing their medication."
About Acute Coronary Syndrome
Acute coronary syndrome is an umbrella term used to cover any group of clinical symptoms associated with acute myocardial ischemia, which is chest pain due to insufficient blood supply to the heart muscle that results from coronary artery disease.
2008 European Society of Cardiology Congress
The study included 2,234 patients who were prescribed statin therapy after an acute coronary syndrome. Patients were followed for one year after discharge from the hospital. For those who discontinued their therapy, median time to discontinuation was 35 days.
"Patients who have survived one acute coronary event are at an increased risk for additional cardiovascular events such as a heart attack or stroke" said Professor Furio Colivicchi, study author and Director, Clinical Quality Management Unit at the Cardiovascular Department, San Filippo Neri Hospital, Rome, Italy. "The vast majority of this high-risk patient population is expected to benefit significantly from long-term statin therapy. Yet many of these patients quickly stop taking their prescribed statins. This study shows how dangerous that decision can be, since it increases their chance of death."
"Discontinuation of medication is common in clinical practice," Dr. Colivicchi continued. "This study tells us that patient care needs to be improved as patients are transitioned from a hospital setting to outpatient care, where medication persistence is often overlooked. Physicians need to keep their patients informed of critical information such as the potentially deadly consequences of foregoing their medication."
About Acute Coronary Syndrome
Acute coronary syndrome is an umbrella term used to cover any group of clinical symptoms associated with acute myocardial ischemia, which is chest pain due to insufficient blood supply to the heart muscle that results from coronary artery disease.
2008 European Society of Cardiology Congress
Researchers compare drugs used to prevent osteoporosis
Raloxifene, a drug used to prevent osteoporosis in postmenopausal women, and conjugated equine estrogen (CEE, a hormone therapy) help increase bone density, although CEE seems to be more effective, according to an article in the April 26 issue of The Archives of Internal Medicine, one of the JAMA/Archives journals.
According to information in the article, raloxifene helps prevent bone loss and increases bone mineral density, and CEE has also been used to help prevent osteoporosis. However, there is little information comparing the two drugs.
Ian R. Reid, M.D., of The University of Auckland, New Zealand, and colleagues compared the effects of CEE and different dosages of raloxifene on bone mineral density in 619 postmenopausal women (average age, 53 years) with prior hysterectomy at 38 medical centers in Europe, North America, Australasia and South Africa.
In this randomized, placebo-controlled trial, women were randomly assigned to take either 60 milligrams per day of raloxifene, 150 milligrams per day of raloxifene, 0.625 milligrams per day of CEE, or placebo. Bone mineral density was measured in the spine and in the femur (a large bone in the leg). The study lasted three years.
The researchers found that bone density declined by two percent in the placebo group, was stable in the two raloxifene groups, and increased by 4.6 percent in the CEE group. At three years, total cholesterol levels were not different compared to the beginning of the study for the placebo group and the CEE group, however, triglyceride concentrations (certain types of fats in the blood) increased by 24.6 percent in the CEE group at three years, a significantly greater change than in the raloxifene groups, which were 4.9 percent and 8.0 percent above levels at the beginning of the study.
The researchers also found that raloxifene did not affect high-density lipoprotein (HDL) cholesterol (the "good" cholesterol), but CEE increased it by 13.4 percent compared with placebo.
"Raloxifene and CEE have beneficial effects on bone density and bone turnover, although effects of CEE are more marked," write the researchers.
"This is one of few studies to directly compare the effects of treatments widely used in the management of osteoporosis. Its findings are broadly consistent with previous data relating to raloxifene, other selective estrogen receptor modulators, and estrogen. Modest changes in bone turnover markers have been reported with raloxifene, whereas those associated with the use of estrogen have tended to be larger, as found in the present study."
(Arch Intern Med. 2004;164:871-879. Available post-embargo at archinternmed)
Editor's Note: This study was supported by a grant from Lilly Research Laboratories.
For more information, contact JAMA/Archives Media Relations at 312/464-JAMA (5262) or e-mail mediarelationsjama-archives.
To contact Ian R. Reid. M.D., e-mail i.reidauckland.ac.nz.
Contact: Ian R. Reid, M.D.
i.reidauckland.ac.nz
JAMA and Archives Journals Website
According to information in the article, raloxifene helps prevent bone loss and increases bone mineral density, and CEE has also been used to help prevent osteoporosis. However, there is little information comparing the two drugs.
Ian R. Reid, M.D., of The University of Auckland, New Zealand, and colleagues compared the effects of CEE and different dosages of raloxifene on bone mineral density in 619 postmenopausal women (average age, 53 years) with prior hysterectomy at 38 medical centers in Europe, North America, Australasia and South Africa.
In this randomized, placebo-controlled trial, women were randomly assigned to take either 60 milligrams per day of raloxifene, 150 milligrams per day of raloxifene, 0.625 milligrams per day of CEE, or placebo. Bone mineral density was measured in the spine and in the femur (a large bone in the leg). The study lasted three years.
The researchers found that bone density declined by two percent in the placebo group, was stable in the two raloxifene groups, and increased by 4.6 percent in the CEE group. At three years, total cholesterol levels were not different compared to the beginning of the study for the placebo group and the CEE group, however, triglyceride concentrations (certain types of fats in the blood) increased by 24.6 percent in the CEE group at three years, a significantly greater change than in the raloxifene groups, which were 4.9 percent and 8.0 percent above levels at the beginning of the study.
The researchers also found that raloxifene did not affect high-density lipoprotein (HDL) cholesterol (the "good" cholesterol), but CEE increased it by 13.4 percent compared with placebo.
"Raloxifene and CEE have beneficial effects on bone density and bone turnover, although effects of CEE are more marked," write the researchers.
"This is one of few studies to directly compare the effects of treatments widely used in the management of osteoporosis. Its findings are broadly consistent with previous data relating to raloxifene, other selective estrogen receptor modulators, and estrogen. Modest changes in bone turnover markers have been reported with raloxifene, whereas those associated with the use of estrogen have tended to be larger, as found in the present study."
(Arch Intern Med. 2004;164:871-879. Available post-embargo at archinternmed)
Editor's Note: This study was supported by a grant from Lilly Research Laboratories.
For more information, contact JAMA/Archives Media Relations at 312/464-JAMA (5262) or e-mail mediarelationsjama-archives.
To contact Ian R. Reid. M.D., e-mail i.reidauckland.ac.nz.
Contact: Ian R. Reid, M.D.
i.reidauckland.ac.nz
JAMA and Archives Journals Website
What Do Fats Do In The Body?
It's common knowledge that too much cholesterol and other fats can lead to disease, and that a healthy diet involves watching how much fatty food we eat. However, our bodies need a certain amount of fat to function-and we can't make it from scratch.
Triglycerides, cholesterol and other essential fatty acids-the scientific term for fats the body can't make on its own-store energy, insulate us and protect our vital organs. They act as messengers, helping proteins do their jobs. They also start chemical reactions that help control growth, immune function, reproduction and other aspects of basic metabolism.
The cycle of making, breaking, storing and mobilizing fats is at the core of how humans and all animals regulate their energy. An imbalance in any step can result in disease, including heart disease and diabetes. For instance, having too many triglycerides in our bloodstream raises our risk of clogged arteries, which can lead to heart attack and stroke.
Fats help the body stockpile certain nutrients as well. The so-called "fat-soluble" vitamins-A, D, E and K-are stored in the liver and in fatty tissues.
Knowing that fats play such an important role in many basic functions in the body, researchers funded by the National Institutes of Health study them in humans and other organisms to learn more about normal and abnormal biology.
Looking to Insects for Insight into Fat Regulation
Despite fat's importance, no one yet understands exactly how humans store it and call it into action. In search of insight, Oklahoma State University biochemist Estela Arrese studies triglyceride metabolism in unexpected places: silkworms, fruit flies and mosquitoes.
The main type of fat we consume, triglycerides are especially suited for energy storage because they pack more than twice as much energy as carbohydrates or proteins.
Once triglycerides have been broken down during digestion, they are shipped out to cells through the bloodstream. Some of the fat gets used for energy right away. The rest is stored inside cells in blobs called lipid droplets.
When we need extra energy-for instance, when we run a marathon-our bodies use enzymes called lipases to break down the stored triglycerides. The cell's power plants, mitochondria, can then create more of the body's main energy source: adenosine triphosphate, or ATP.
Arrese works to identify, purify and determine the roles of individual proteins involved in triglyceride metabolism. Her lab was the first to purify the main fat regulation protein in insects, TGL, and now she is trying to learn what it does. She also discovered the function of a key lipid droplet protein called Lsd1, and she is investigating its sister, Lsd2.
Arrese's work could teach us more about disorders like diabetes, obesity and heart disease. Plus, by understanding how insects use fat when they metamorphose and lay eggs and by hypothesizing how to disrupt those processes, her discoveries could lead to new ways for farmers to protect their crops from pests and for health officials to combat mosquito-borne diseases like malaria and West Nile virus.
But before any of that can happen, says Arrese, "We need to study a lot and have information at the molecular level."
Cholesterol and Cell Membranes
One of Arrese's challenges is trying to get oily substances like fat to work in lab tests, which tend to be water-based. However, our cells couldn't function without fat and water's mutual dislike.
Cell membranes encase our cells and the organelles inside them. Fat-specifically, cholesterol-makes these membranes possible. The fatty ends of membrane molecules veer away from the water inside and outside cells, while the non-fatty ends gravitate toward it. The molecules spontaneously line up to form a semi-permeable membrane. The result: flexible protective barriers that, like bouncers at a club, only allow the appropriate molecules to cross into and out of cells.
Chew on that the next time you ponder the fate of the fat in a French fry.
Triglycerides, cholesterol and other essential fatty acids-the scientific term for fats the body can't make on its own-store energy, insulate us and protect our vital organs. They act as messengers, helping proteins do their jobs. They also start chemical reactions that help control growth, immune function, reproduction and other aspects of basic metabolism.
The cycle of making, breaking, storing and mobilizing fats is at the core of how humans and all animals regulate their energy. An imbalance in any step can result in disease, including heart disease and diabetes. For instance, having too many triglycerides in our bloodstream raises our risk of clogged arteries, which can lead to heart attack and stroke.
Fats help the body stockpile certain nutrients as well. The so-called "fat-soluble" vitamins-A, D, E and K-are stored in the liver and in fatty tissues.
Knowing that fats play such an important role in many basic functions in the body, researchers funded by the National Institutes of Health study them in humans and other organisms to learn more about normal and abnormal biology.
Looking to Insects for Insight into Fat Regulation
Despite fat's importance, no one yet understands exactly how humans store it and call it into action. In search of insight, Oklahoma State University biochemist Estela Arrese studies triglyceride metabolism in unexpected places: silkworms, fruit flies and mosquitoes.
The main type of fat we consume, triglycerides are especially suited for energy storage because they pack more than twice as much energy as carbohydrates or proteins.
Once triglycerides have been broken down during digestion, they are shipped out to cells through the bloodstream. Some of the fat gets used for energy right away. The rest is stored inside cells in blobs called lipid droplets.
When we need extra energy-for instance, when we run a marathon-our bodies use enzymes called lipases to break down the stored triglycerides. The cell's power plants, mitochondria, can then create more of the body's main energy source: adenosine triphosphate, or ATP.
Arrese works to identify, purify and determine the roles of individual proteins involved in triglyceride metabolism. Her lab was the first to purify the main fat regulation protein in insects, TGL, and now she is trying to learn what it does. She also discovered the function of a key lipid droplet protein called Lsd1, and she is investigating its sister, Lsd2.
Arrese's work could teach us more about disorders like diabetes, obesity and heart disease. Plus, by understanding how insects use fat when they metamorphose and lay eggs and by hypothesizing how to disrupt those processes, her discoveries could lead to new ways for farmers to protect their crops from pests and for health officials to combat mosquito-borne diseases like malaria and West Nile virus.
But before any of that can happen, says Arrese, "We need to study a lot and have information at the molecular level."
Cholesterol and Cell Membranes
One of Arrese's challenges is trying to get oily substances like fat to work in lab tests, which tend to be water-based. However, our cells couldn't function without fat and water's mutual dislike.
Cell membranes encase our cells and the organelles inside them. Fat-specifically, cholesterol-makes these membranes possible. The fatty ends of membrane molecules veer away from the water inside and outside cells, while the non-fatty ends gravitate toward it. The molecules spontaneously line up to form a semi-permeable membrane. The result: flexible protective barriers that, like bouncers at a club, only allow the appropriate molecules to cross into and out of cells.
Chew on that the next time you ponder the fate of the fat in a French fry.
ZETIA(R) with fenofibrate provided complementary lipid lowering efficacy
Ezetimibe and fenofibrate treatment well-tolerated over 12 weeks -
Results from a new study showed that coadministration of ZETIA® (ezetimibe) and fenofibrate significantly reduced LDL ("bad")
cholesterol (LDL-C), non-high density lipoprotein cholesterol (non-HDL-C) and apo B in patients with mixed hyperlipidemia and
high LDL cholesterol when compared to fenofibrate alone. The study, presented today at the 2004 American Heart Association
Scientific Sessions, also showed that significant increases in HDL cholesterol and decreases in trigycerides (TG) similar to
those seen with fenofibrate alone were seen in patients on ZETIA co-administered with fenofibrate. The treatment with ZETIA
and fenofibrate for 12 weeks was also well-tolerated with a safety profile comparable to fenofibrate monotherapy. The label
for ZETIA indicates that the safety and effectiveness of ZETIA with fibrates have not been established, therefore
co-administration with fibrates is not recommended.
"This is the first large study to indicate that co-administration of ZETIA and fenofibrate significantly lowers LDL
cholesterol and non-HDL cholesterol more than fenofibrate alone in a mixed hyperlipidemia population. This study revealed
that when diet changes alone were not sufficient in mixed hyperlipidemia, the co-administration of ezetimibe and fenofibrate
significantly lowered LDL cholesterol, compared to fenofibrate alone. ZETIA co-administered with fenofibrate also improved
HDL cholesterol and triglyceride levels similar to fenofibrate alone," said Mason Wright Freeman, M.D., chief, Lipid
Metabolism Unit, Massachusetts General Hospital. "Mixed hyperlipidemia is a metabolic disorder characterized by elevated LDL
cholesterol, non HDL-C and TG and reduced levels of HDL cholesterol. Co-administration of ZETIA and fenofibrate is not
indicated for use in the label for ZETIA, however further studies in these populations are certainly warranted to confirm
these findings."
ZETIA co-administered with fenofibrate provided significant LDL cholesterol reduction compared to fenofibrate alone
In a multicenter, randomized, double-blind, placebo-controlled, parallel arm trial, 619 patients were randomized in a 3:3:3:1
ratio to one of four daily treatments for 12 weeks: ZETIA 10 mg (n=185), fenofibrate 160 mg (n=188), ZETIA 10 mg plus
fenofibrate 160 mg (n=183) and placebo (n=63). The study population was comprised of 619 patients, ages 18 to 75 with mixed
hyperlipidemia after a six to eight week washout and dietary run-in period. Baseline LDL cholesterol levels ranged from 130
to 220 mg/dL (100 to 180 mg/dL for patients with type 2 diabetes) and triglycerides (TG) from 200 to 500 mg/dL; patients with
a history of coronary heart disease (CHD), CHD-equivalent disease (except for type 2 diabetes) or CHD risk greater than 20
percent (except for type 2 diabetes) as defined by NCEP ATP III criteria were excluded.
The primary endpoint of this study compared the LDL cholesterol lowering efficacy of ZETIA plus fenofibrate versus
fenofibrate alone. After 12 weeks, the co-administration of ZETIA and fenofibrate significantly reduced LDL cholesterol,
non-HDL cholesterol, and apo B to a greater extent than ZETIA alone or fenofibrate alone (p
Results from a new study showed that coadministration of ZETIA® (ezetimibe) and fenofibrate significantly reduced LDL ("bad")
cholesterol (LDL-C), non-high density lipoprotein cholesterol (non-HDL-C) and apo B in patients with mixed hyperlipidemia and
high LDL cholesterol when compared to fenofibrate alone. The study, presented today at the 2004 American Heart Association
Scientific Sessions, also showed that significant increases in HDL cholesterol and decreases in trigycerides (TG) similar to
those seen with fenofibrate alone were seen in patients on ZETIA co-administered with fenofibrate. The treatment with ZETIA
and fenofibrate for 12 weeks was also well-tolerated with a safety profile comparable to fenofibrate monotherapy. The label
for ZETIA indicates that the safety and effectiveness of ZETIA with fibrates have not been established, therefore
co-administration with fibrates is not recommended.
"This is the first large study to indicate that co-administration of ZETIA and fenofibrate significantly lowers LDL
cholesterol and non-HDL cholesterol more than fenofibrate alone in a mixed hyperlipidemia population. This study revealed
that when diet changes alone were not sufficient in mixed hyperlipidemia, the co-administration of ezetimibe and fenofibrate
significantly lowered LDL cholesterol, compared to fenofibrate alone. ZETIA co-administered with fenofibrate also improved
HDL cholesterol and triglyceride levels similar to fenofibrate alone," said Mason Wright Freeman, M.D., chief, Lipid
Metabolism Unit, Massachusetts General Hospital. "Mixed hyperlipidemia is a metabolic disorder characterized by elevated LDL
cholesterol, non HDL-C and TG and reduced levels of HDL cholesterol. Co-administration of ZETIA and fenofibrate is not
indicated for use in the label for ZETIA, however further studies in these populations are certainly warranted to confirm
these findings."
ZETIA co-administered with fenofibrate provided significant LDL cholesterol reduction compared to fenofibrate alone
In a multicenter, randomized, double-blind, placebo-controlled, parallel arm trial, 619 patients were randomized in a 3:3:3:1
ratio to one of four daily treatments for 12 weeks: ZETIA 10 mg (n=185), fenofibrate 160 mg (n=188), ZETIA 10 mg plus
fenofibrate 160 mg (n=183) and placebo (n=63). The study population was comprised of 619 patients, ages 18 to 75 with mixed
hyperlipidemia after a six to eight week washout and dietary run-in period. Baseline LDL cholesterol levels ranged from 130
to 220 mg/dL (100 to 180 mg/dL for patients with type 2 diabetes) and triglycerides (TG) from 200 to 500 mg/dL; patients with
a history of coronary heart disease (CHD), CHD-equivalent disease (except for type 2 diabetes) or CHD risk greater than 20
percent (except for type 2 diabetes) as defined by NCEP ATP III criteria were excluded.
The primary endpoint of this study compared the LDL cholesterol lowering efficacy of ZETIA plus fenofibrate versus
fenofibrate alone. After 12 weeks, the co-administration of ZETIA and fenofibrate significantly reduced LDL cholesterol,
non-HDL cholesterol, and apo B to a greater extent than ZETIA alone or fenofibrate alone (p
Pharmacists vital in cholesterol control - new study
The idea of pharmacists as simple drug distributors is archaic, and a new study out of the University of Alberta proves it.
Pharmacists who provided consultation services for a six month period to patients at high risk for cardiovascular diseases were able to reduce their patients' cholesterol levels by an average of 13 per cent, said Dr. Ross Tsuyuki, a professor in the U of A Department of Medicine (USA) and the lead author of the study, which has been published in the American Journal of Medicine this month.
'As a rule of thumb, each one per cent reduction in cholesterol reduces the risk of heart disease between two to three times,' Tsuyuki said.
In the study, which was completed at 42 pharmacies across Canada, patients at high risk for cardiovascular disease and not at their target cholesterol level received consultations with their pharmacist about their condition.
The patients' cholesterol levels were measured and they were advised about proper use and side effects of cholesterol medication, lifestyle choices, and the management of other risk factors, such as smoking, hypertension, and diabetes.
In addition, this information was shared with each patient's family physician, and each patient was
referred to their family physician as necessary.
'We think the 13 per cent reduction of cholesterol would have been even greater if we continued the study for a longer period,' Tsuyuki said.
An average person sees their pharmacist between five and eight times more often than they see their doctor, Tsuyuki said, adding the major difficulty in treating high cholesterol is that it does not show any symptoms and most people are unaware of their own level of risk from it and often do not seek medical care.
'Our study showed that an enhanced pharmacist care program was associated with a reduction in cholesterol levels,' Tsuyuki said. 'In the context of primary health care reform, programs such as this, where patients have regular consultations with their community pharmacists--working with the patient and the patient's family physician--should be strongly considered, as they are community based, accessible, multidisciplinary, and effective.'
Tsuyuki acknowledged the programs would cost money to run, but said he believes they would save money in the long run.
'If you look at the costs of bypass surgery or a balloon angioplasty, for example, you'll see that if we can prevent just a few of those procedures we'll be saving money,' he said.
'Pharmacists are well-trained and under used, and with the well-documented shortage of physicians in the country, turning to pharmacists is one way to help alleviate this problem.'
Contact: Ryan Smith
ryan.smithualberta.ca
780-492-0436
University of Alberta
Dr. Tsuyuki can be reached at 780-492-8526 or ross.tsuyukiualberta.ca
Pharmacists who provided consultation services for a six month period to patients at high risk for cardiovascular diseases were able to reduce their patients' cholesterol levels by an average of 13 per cent, said Dr. Ross Tsuyuki, a professor in the U of A Department of Medicine (USA) and the lead author of the study, which has been published in the American Journal of Medicine this month.
'As a rule of thumb, each one per cent reduction in cholesterol reduces the risk of heart disease between two to three times,' Tsuyuki said.
In the study, which was completed at 42 pharmacies across Canada, patients at high risk for cardiovascular disease and not at their target cholesterol level received consultations with their pharmacist about their condition.
The patients' cholesterol levels were measured and they were advised about proper use and side effects of cholesterol medication, lifestyle choices, and the management of other risk factors, such as smoking, hypertension, and diabetes.
In addition, this information was shared with each patient's family physician, and each patient was
referred to their family physician as necessary.
'We think the 13 per cent reduction of cholesterol would have been even greater if we continued the study for a longer period,' Tsuyuki said.
An average person sees their pharmacist between five and eight times more often than they see their doctor, Tsuyuki said, adding the major difficulty in treating high cholesterol is that it does not show any symptoms and most people are unaware of their own level of risk from it and often do not seek medical care.
'Our study showed that an enhanced pharmacist care program was associated with a reduction in cholesterol levels,' Tsuyuki said. 'In the context of primary health care reform, programs such as this, where patients have regular consultations with their community pharmacists--working with the patient and the patient's family physician--should be strongly considered, as they are community based, accessible, multidisciplinary, and effective.'
Tsuyuki acknowledged the programs would cost money to run, but said he believes they would save money in the long run.
'If you look at the costs of bypass surgery or a balloon angioplasty, for example, you'll see that if we can prevent just a few of those procedures we'll be saving money,' he said.
'Pharmacists are well-trained and under used, and with the well-documented shortage of physicians in the country, turning to pharmacists is one way to help alleviate this problem.'
Contact: Ryan Smith
ryan.smithualberta.ca
780-492-0436
University of Alberta
Dr. Tsuyuki can be reached at 780-492-8526 or ross.tsuyukiualberta.ca
Mate Tea Lowers Cholesterol
When a study in her lab showed that mate (mah' ta) tea drinkers had experienced a significant increase in the activity of an enzyme that promotes HDL (good) cholesterol while lowering LDL (bad) cholesterol, University of Illinois scientist Elvira de Mejia headed for Argentina where mate tea has been grown and taken medicinally for centuries.
She returned with a five-year agreement signed by administrators of La Universidad Nacional de Misiones (UNaM) to cooperate in the study of 84 genotypes of mate tea, both cultivated and wild, never-before-studied, varieties. The arrangement calls for the writing of joint grants and an exchange of students and professors between UNaM and the U of I.
The scientist is also negotiating a grant from the National Institute of Yerba Mate to fund further research, she said.
"Our studies show that some of the most important antioxidant enzymes in the body are induced by this herbal tea," said de Mejia of her study in September's Planta Medica.
"Because Argentina has the different mate varieties, we'll be able to do more comparisons and characterizations between the different genotypes and the benefits of different growing conditions -- whether in sun (on a plantation) or in shade (under the rainforest canopy)," she added.
Not only does de Mejia hope to identify the most nutritionally beneficial genotypes of the herbal tea, she hopes that Argentine experience with drying and processing mate will lead to improved extraction of the tea's bioactive compounds. "Food companies are very interested in adding tea extracts to juices, soda, and even beer to increase the nutritional value of their products," she said.
In the cholesterol study, blood levels of the cardio-protective enzyme paraoxonase-1 were measured before and after healthy volunteers consumed either 0.5 liters of mate tea, milk, or coffee. Activity of the enzyme increased an average of 10 percent for mate tea drinkers compared to the other drinks.
"The tea used in the study was prepared at the same concentration used in South America, although they usually drink 2 to 3 liters per day," said de Mejia.
In South America, mate is usually drunk from a dried gourd and consumed through a metal straw. About 50 grams of dry leaves are packed into the gourd and hot water is poured over them; this is repeated many times, with as much as ?? to 1 liter of water. This method of consumption allows tea drinkers to slowly extract the antioxidants and polyphenols before they can be oxidized.
"To duplicate these results with mate teabags, you would need to use four or five teabags instead of one. It's a strong taste, but many people say that coffee has a strong, bitter taste. This is more of a grassy herbal taste. It may be an acquired taste, but I seem to have acquired it," said graduate student Caleb Heck who accompanied de Mejia to Argentina.
Heck characterized the tea consumed in the cholesterol study in de Mejia's U of I labs and is now working with the tea brought back from Argentina. He said that mate is high in xanthines (mainly caffeine), and he has found 12 polyphenolic compounds at different concentrations, depending on where the tea was grown. Polyphenols are thought to have a protective effect against cancer and cardiovascular disease.
He is quickly becoming something of an authority on the subject, and he and de Mejia have written a comprehensive review of mate tea, including its chemistry, health implications, and the technological considerations involved in its processing, that has been published in November's Journal of Food Science. The study was funded by the University of Illinois Research Board.
Heck and de Mejia of the U of I and Teresita Menini and Alejandro Gugliucci of Touro University co-authored the study of the effect of mate tea on HDL cholesterol, which appears in the September issue of Planta Medica. The study was funded by the University of Illinois Research Board and Touro University.
She returned with a five-year agreement signed by administrators of La Universidad Nacional de Misiones (UNaM) to cooperate in the study of 84 genotypes of mate tea, both cultivated and wild, never-before-studied, varieties. The arrangement calls for the writing of joint grants and an exchange of students and professors between UNaM and the U of I.
The scientist is also negotiating a grant from the National Institute of Yerba Mate to fund further research, she said.
"Our studies show that some of the most important antioxidant enzymes in the body are induced by this herbal tea," said de Mejia of her study in September's Planta Medica.
"Because Argentina has the different mate varieties, we'll be able to do more comparisons and characterizations between the different genotypes and the benefits of different growing conditions -- whether in sun (on a plantation) or in shade (under the rainforest canopy)," she added.
Not only does de Mejia hope to identify the most nutritionally beneficial genotypes of the herbal tea, she hopes that Argentine experience with drying and processing mate will lead to improved extraction of the tea's bioactive compounds. "Food companies are very interested in adding tea extracts to juices, soda, and even beer to increase the nutritional value of their products," she said.
In the cholesterol study, blood levels of the cardio-protective enzyme paraoxonase-1 were measured before and after healthy volunteers consumed either 0.5 liters of mate tea, milk, or coffee. Activity of the enzyme increased an average of 10 percent for mate tea drinkers compared to the other drinks.
"The tea used in the study was prepared at the same concentration used in South America, although they usually drink 2 to 3 liters per day," said de Mejia.
In South America, mate is usually drunk from a dried gourd and consumed through a metal straw. About 50 grams of dry leaves are packed into the gourd and hot water is poured over them; this is repeated many times, with as much as ?? to 1 liter of water. This method of consumption allows tea drinkers to slowly extract the antioxidants and polyphenols before they can be oxidized.
"To duplicate these results with mate teabags, you would need to use four or five teabags instead of one. It's a strong taste, but many people say that coffee has a strong, bitter taste. This is more of a grassy herbal taste. It may be an acquired taste, but I seem to have acquired it," said graduate student Caleb Heck who accompanied de Mejia to Argentina.
Heck characterized the tea consumed in the cholesterol study in de Mejia's U of I labs and is now working with the tea brought back from Argentina. He said that mate is high in xanthines (mainly caffeine), and he has found 12 polyphenolic compounds at different concentrations, depending on where the tea was grown. Polyphenols are thought to have a protective effect against cancer and cardiovascular disease.
He is quickly becoming something of an authority on the subject, and he and de Mejia have written a comprehensive review of mate tea, including its chemistry, health implications, and the technological considerations involved in its processing, that has been published in November's Journal of Food Science. The study was funded by the University of Illinois Research Board.
Heck and de Mejia of the U of I and Teresita Menini and Alejandro Gugliucci of Touro University co-authored the study of the effect of mate tea on HDL cholesterol, which appears in the September issue of Planta Medica. The study was funded by the University of Illinois Research Board and Touro University.
PreMD Announces FDA Decision On POC Skin Cholesterol Test
Predictive medicine company
PreMD Inc. (TSX: PMD; Amex: PME) announced that it has received a
non-substantially equivalent (NSE) letter from the U.S. Food and Drug
Administration (FDA) regarding the 510(k) submission for an expanded
regulatory claim on its point-of-care (POC) skin cholesterol test. The
company expects to evaluate its options as part of the plans to address
this issue.
"We are very disappointed with this decision by the FDA regarding our
510(k) submission. We believe we have provided adequate information to
support clearance and continue to believe that our product merits clearance
by the FDA," said Brent Norton, president and chief executive officer of
PreMD. "The company is pursuing the next steps in addressing the decision
and we will work through the process as expeditiously as possible. We
continue to believe that this test fulfills a need for screening
asymptomatic patients for risk of cardiovascular disease. Furthermore, our
recent clinical achievements such as our presentation at the American Heart
Association and scheduled publication in the American Journal of Cardiology
for April show that we are supported in our belief of the strength of our
product. The company has adequate cash to support operations through the
near term. However, we will continue to evaluate and decrease spending
throughout the organization to ensure our ability to execute the necessary
tasks."
The FDA's primary grounds for rejecting the claim relate to the
clinical utility of evaluating skin cholesterol with carotid wall intima
thickness (CIMT) as the clinical endpoint. PreMD submitted the 510(k)
application to the FDA in June 2007 based on a study design that was
previously accepted as appropriate by the FDA. Subsequently, the FDA
requested additional information regarding statistical clarification on the
data submitted. The company promptly provided the information requested and
believes that it addressed those concerns to the best capabilities of the
company. PreMD was not aware of the FDA's issue or concerns from previous
discussions.
About PreMD Inc.
PreMD Inc. is a leader in predictive medicine, dedicated to developing
rapid, non-invasive tests for the early detection of life-threatening
diseases. PreMD's cardiovascular products include a line of non-invasive
skin cholesterol tests, planned to be marketed and distributed by
AstraZeneca Pharmaceuticals. PreMD's other skin cholesterol products
include PREVU(x) LT, a skin cholesterol test designed for use in the life
insurance industry. The company's cancer tests include ColorectAlert(TM),
LungAlert(TM) and a breast cancer test. PreMD's head office is located in
Toronto, Ontario and its research and product development facility is at
McMaster University in Hamilton, Ontario. For more information about PreMD,
please visit premdinc.
This press release contains forward-looking statements. These
statements involve known and unknown risks and uncertainties, which could
cause the Company's actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include, among
others, the success of a plan for regaining compliance with certain
continued listing standards of the American Stock Exchange, successful
development or marketing of the Company's products, the competitiveness of
the Company's products if successfully commercialized, the lack of
operating profit and availability of funds and resources to pursue R&D
projects, the successful and timely completion of clinical studies, product
liability, reliance on third-party manufacturers, the ability of the
Company to take advantage of business opportunities, uncertainties related
to the regulatory process, and general changes in economic conditions.
In addition, while the Company routinely obtains patents for its
products and technology, the protection offered by the Company's patents
and patent applications may be challenged, invalidated or circumvented by
our competitors and there can be no guarantee of our ability to obtain or
maintain patent protection for our products or product candidates.
Investors should consult the Company's quarterly and annual filings with
the Canadian and U.S. securities commissions for additional information on
risks and uncertainties relating to the forward-looking statements.
Investors are cautioned not to rely on these forward-looking statements.
PreMD is providing this information as of the date of this press release
and does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new information,
future events or otherwise.
PreMD Inc.
premdinc
PreMD Inc. (TSX: PMD; Amex: PME) announced that it has received a
non-substantially equivalent (NSE) letter from the U.S. Food and Drug
Administration (FDA) regarding the 510(k) submission for an expanded
regulatory claim on its point-of-care (POC) skin cholesterol test. The
company expects to evaluate its options as part of the plans to address
this issue.
"We are very disappointed with this decision by the FDA regarding our
510(k) submission. We believe we have provided adequate information to
support clearance and continue to believe that our product merits clearance
by the FDA," said Brent Norton, president and chief executive officer of
PreMD. "The company is pursuing the next steps in addressing the decision
and we will work through the process as expeditiously as possible. We
continue to believe that this test fulfills a need for screening
asymptomatic patients for risk of cardiovascular disease. Furthermore, our
recent clinical achievements such as our presentation at the American Heart
Association and scheduled publication in the American Journal of Cardiology
for April show that we are supported in our belief of the strength of our
product. The company has adequate cash to support operations through the
near term. However, we will continue to evaluate and decrease spending
throughout the organization to ensure our ability to execute the necessary
tasks."
The FDA's primary grounds for rejecting the claim relate to the
clinical utility of evaluating skin cholesterol with carotid wall intima
thickness (CIMT) as the clinical endpoint. PreMD submitted the 510(k)
application to the FDA in June 2007 based on a study design that was
previously accepted as appropriate by the FDA. Subsequently, the FDA
requested additional information regarding statistical clarification on the
data submitted. The company promptly provided the information requested and
believes that it addressed those concerns to the best capabilities of the
company. PreMD was not aware of the FDA's issue or concerns from previous
discussions.
About PreMD Inc.
PreMD Inc. is a leader in predictive medicine, dedicated to developing
rapid, non-invasive tests for the early detection of life-threatening
diseases. PreMD's cardiovascular products include a line of non-invasive
skin cholesterol tests, planned to be marketed and distributed by
AstraZeneca Pharmaceuticals. PreMD's other skin cholesterol products
include PREVU(x) LT, a skin cholesterol test designed for use in the life
insurance industry. The company's cancer tests include ColorectAlert(TM),
LungAlert(TM) and a breast cancer test. PreMD's head office is located in
Toronto, Ontario and its research and product development facility is at
McMaster University in Hamilton, Ontario. For more information about PreMD,
please visit premdinc.
This press release contains forward-looking statements. These
statements involve known and unknown risks and uncertainties, which could
cause the Company's actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include, among
others, the success of a plan for regaining compliance with certain
continued listing standards of the American Stock Exchange, successful
development or marketing of the Company's products, the competitiveness of
the Company's products if successfully commercialized, the lack of
operating profit and availability of funds and resources to pursue R&D
projects, the successful and timely completion of clinical studies, product
liability, reliance on third-party manufacturers, the ability of the
Company to take advantage of business opportunities, uncertainties related
to the regulatory process, and general changes in economic conditions.
In addition, while the Company routinely obtains patents for its
products and technology, the protection offered by the Company's patents
and patent applications may be challenged, invalidated or circumvented by
our competitors and there can be no guarantee of our ability to obtain or
maintain patent protection for our products or product candidates.
Investors should consult the Company's quarterly and annual filings with
the Canadian and U.S. securities commissions for additional information on
risks and uncertainties relating to the forward-looking statements.
Investors are cautioned not to rely on these forward-looking statements.
PreMD is providing this information as of the date of this press release
and does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new information,
future events or otherwise.
PreMD Inc.
premdinc
Cholesterol Screening A Cost-Effective Procedure To Extend Life In Hodgkin's Survivors
Hodgkin's lymphoma survivors who have lipid screening every five years to detect high cholesterol will live a half year longer than patients who don't have the screening and the intervention is cost-effective, according to a study presented November 8, 2006, at the American Society for Therapeutic Radiology and Oncology's 48th Annual Meeting in Philadelphia.
"Although physicians are aware that Hodgkin's lymphoma survivors are at increased risk of heart disease, it hasn't been well-established how to best monitor these patients," said Aileen Chen, M.D., M.P.P, lead author of the study and a radiation oncologist at the Dana-Farber Cancer Center in Boston. "Our study shows that lipid screening in Hodgkin's survivors is cost effective and provides physicians with a guideline on how frequently they should be screening for high cholesterol, an important risk factor for heart disease."
Hodgkin's lymphoma survivors who received radiation therapy to the chest to cure their cancer are at an increased risk of heart disease compared to the general population because the heart (located in the chest cavity) receives a small amount of radiation when the nearby lymph nodes are treated. Hodgkin's survivors who have high cholesterol are more likely to develop heart disease.
Lipid screening tests are simple blood tests that check the level of lipids or cholesterol in the blood. A high level of cholesterol increases the chance of having heart disease which can lead to heart attacks. If caught early, this condition can be treated with cholesterol-lowering medications.
Dr. Chen's study compared lipid screening every five years starting five years after treatment versus no lipid screening in a cohort of 25-year-old Hodgkin's survivors treated with chest radiation. Patients who screened positive for high cholesterol were treated with statins, a type of cholesterol-lowering medication which has been shown to reduce the risk of heart attacks and death from heart disease. The study found that patients who had lipid screening, with statin therapy, if needed, lived six months longer than those who had no screening test.
For more information on radiation therapy for Hodgkin's Lymphoma, visit rtanswers.
The abstract, "Cost-effectiveness of Lipid Screening in Hodgkin's Disease Survivors," will be presented in a scientific session on Wednesday, November 8, at 11:05 a.m.
American Society for Therapeutic Radiology and Oncology (ASTRO)
8280 Willow Oaks Corporate Dr., Ste 500
Fairfax, VA 22031
United States
astro
"Although physicians are aware that Hodgkin's lymphoma survivors are at increased risk of heart disease, it hasn't been well-established how to best monitor these patients," said Aileen Chen, M.D., M.P.P, lead author of the study and a radiation oncologist at the Dana-Farber Cancer Center in Boston. "Our study shows that lipid screening in Hodgkin's survivors is cost effective and provides physicians with a guideline on how frequently they should be screening for high cholesterol, an important risk factor for heart disease."
Hodgkin's lymphoma survivors who received radiation therapy to the chest to cure their cancer are at an increased risk of heart disease compared to the general population because the heart (located in the chest cavity) receives a small amount of radiation when the nearby lymph nodes are treated. Hodgkin's survivors who have high cholesterol are more likely to develop heart disease.
Lipid screening tests are simple blood tests that check the level of lipids or cholesterol in the blood. A high level of cholesterol increases the chance of having heart disease which can lead to heart attacks. If caught early, this condition can be treated with cholesterol-lowering medications.
Dr. Chen's study compared lipid screening every five years starting five years after treatment versus no lipid screening in a cohort of 25-year-old Hodgkin's survivors treated with chest radiation. Patients who screened positive for high cholesterol were treated with statins, a type of cholesterol-lowering medication which has been shown to reduce the risk of heart attacks and death from heart disease. The study found that patients who had lipid screening, with statin therapy, if needed, lived six months longer than those who had no screening test.
For more information on radiation therapy for Hodgkin's Lymphoma, visit rtanswers.
The abstract, "Cost-effectiveness of Lipid Screening in Hodgkin's Disease Survivors," will be presented in a scientific session on Wednesday, November 8, at 11:05 a.m.
American Society for Therapeutic Radiology and Oncology (ASTRO)
8280 Willow Oaks Corporate Dr., Ste 500
Fairfax, VA 22031
United States
astro
News From The Annals Of Internal Medicine, May 6, 2008
Study Finds Little Difference in Osteoporosis Drugs for Preventing Fractures
A study of pharmacy records of 43,135 people who began to take osteoporosis drugs between 2000 and 2005 found 1,051 nonvertebral fractures within 12 months and no large differences in fracture risk between those who took risedronate, raloxifene, and alendronate (Article, p. 637). Those who took nasal calcitonin had more nonvertebral fractures than those who took alendronate.
A study like this one, which uses existing administrative data to compare drugs directly, has important shortcomings: The researchers did not know if patients actually took the medications, could not measure side effects, and did not know why physicians prescribed one medication over another.
An editorial writer says that this study is an attempt to solve a problem in the U.S. drug approval process, which specifies that a new drug be tested against placebo but not against existing drugs (Editorial, p. 702). So we have several drugs for osteoporosis but no head-to-head trials to guide use. "I propose that we devise an ethical way to prospectively randomly assign patients to different (and apparently equivalent) drug regimens and measure the outcomes of treatment, potential adverse events, drug interactions and costs," the writer says.
How Often Should Cholesterol Levels Be Monitored After Therapy Begins?
Although cholesterol-lowering drugs have become some of the most widely used and expensive pharmaceuticals, guidelines on how often to monitor cholesterol levels while on treatment vary widely, from every four months, to annually, or as necessary (Article, p. 656).
Changes in a person's cholesterol level could be due to random fluctuations (noise) or a long-term effect of the drug (signal). A new study involved more than 9,000 people with past heart disease whose cholesterol levels were measured at regular intervals for five years. Researchers found that for the first four years of treatment, the noise was greater than the signal, making it difficult to accurately identify someone who needed a change in dose.
The results suggest that frequent testing of cholesterol levels while on treatment will often be misleading. "Current guidelines that recommend annual or more frequent monitoring (of cholesterol levels) should be reconsidered," the authors say.
Hydroxyurea Reduces Frequency of Pain and Hospitalizations for Sickle Cell Disease
A review for a consensus conference on hydroxyurea for treatment of adults with sickle cell disease found the drug increases fetal hemoglobin, reduces frequency of extreme pain crises, reduces frequency and/or length of hospital admissions, and reduces the need for transfusions. Hydroxyurea is a chemotherapy agent that affects the bone marrow. Approved by the FDA in 1998 for treatment of adults with sickle cell disease, hydroxyurea remains the only approved disease-modifying therapy.
Note: This article will be posted online at annals/ along with the May 6, 2008, issue of Annals of Internal Medicine. It will appear in the June 17, 2008, print edition of the journal.
High Insurance Deductibles Change Use of Some Cancer Screening Tests
A study of payment records of HMO patients who moved from a standard insurance plan into a high-deductible insurance plan found that patients did not change use of recommended breast or cervical cancer screening (which were fully covered by the new plan) but had fewer screenings for colorectal cancer with colonoscopies (which were not covered until the patient had met the high deductible) (Article, p. 647). The authors say that high-deductible health plans should fully cover mammography, Pap tests, and colonoscopy, because, in the case of colonoscopy, an adequate substitute does not exist.
Editorial writers say, "Cost-sharing is a blunt tool. ??¦ [E]ven small amounts of cost-sharing reduce the use of effective services. However, cost sharing also reduces costs and provides disincentives to choose services that do not improve health or are possibly harmful" (Editorial, p. 704).
Annals of Internal Medicine is published by the American College of Physicians.
A study of pharmacy records of 43,135 people who began to take osteoporosis drugs between 2000 and 2005 found 1,051 nonvertebral fractures within 12 months and no large differences in fracture risk between those who took risedronate, raloxifene, and alendronate (Article, p. 637). Those who took nasal calcitonin had more nonvertebral fractures than those who took alendronate.
A study like this one, which uses existing administrative data to compare drugs directly, has important shortcomings: The researchers did not know if patients actually took the medications, could not measure side effects, and did not know why physicians prescribed one medication over another.
An editorial writer says that this study is an attempt to solve a problem in the U.S. drug approval process, which specifies that a new drug be tested against placebo but not against existing drugs (Editorial, p. 702). So we have several drugs for osteoporosis but no head-to-head trials to guide use. "I propose that we devise an ethical way to prospectively randomly assign patients to different (and apparently equivalent) drug regimens and measure the outcomes of treatment, potential adverse events, drug interactions and costs," the writer says.
How Often Should Cholesterol Levels Be Monitored After Therapy Begins?
Although cholesterol-lowering drugs have become some of the most widely used and expensive pharmaceuticals, guidelines on how often to monitor cholesterol levels while on treatment vary widely, from every four months, to annually, or as necessary (Article, p. 656).
Changes in a person's cholesterol level could be due to random fluctuations (noise) or a long-term effect of the drug (signal). A new study involved more than 9,000 people with past heart disease whose cholesterol levels were measured at regular intervals for five years. Researchers found that for the first four years of treatment, the noise was greater than the signal, making it difficult to accurately identify someone who needed a change in dose.
The results suggest that frequent testing of cholesterol levels while on treatment will often be misleading. "Current guidelines that recommend annual or more frequent monitoring (of cholesterol levels) should be reconsidered," the authors say.
Hydroxyurea Reduces Frequency of Pain and Hospitalizations for Sickle Cell Disease
A review for a consensus conference on hydroxyurea for treatment of adults with sickle cell disease found the drug increases fetal hemoglobin, reduces frequency of extreme pain crises, reduces frequency and/or length of hospital admissions, and reduces the need for transfusions. Hydroxyurea is a chemotherapy agent that affects the bone marrow. Approved by the FDA in 1998 for treatment of adults with sickle cell disease, hydroxyurea remains the only approved disease-modifying therapy.
Note: This article will be posted online at annals/ along with the May 6, 2008, issue of Annals of Internal Medicine. It will appear in the June 17, 2008, print edition of the journal.
High Insurance Deductibles Change Use of Some Cancer Screening Tests
A study of payment records of HMO patients who moved from a standard insurance plan into a high-deductible insurance plan found that patients did not change use of recommended breast or cervical cancer screening (which were fully covered by the new plan) but had fewer screenings for colorectal cancer with colonoscopies (which were not covered until the patient had met the high deductible) (Article, p. 647). The authors say that high-deductible health plans should fully cover mammography, Pap tests, and colonoscopy, because, in the case of colonoscopy, an adequate substitute does not exist.
Editorial writers say, "Cost-sharing is a blunt tool. ??¦ [E]ven small amounts of cost-sharing reduce the use of effective services. However, cost sharing also reduces costs and provides disincentives to choose services that do not improve health or are possibly harmful" (Editorial, p. 704).
Annals of Internal Medicine is published by the American College of Physicians.
Health Tip: Please Pass The Soluble Fiber
Soluble fiber -- from beans, some fruits and even coffee -- may help lower low-density lipoprotein (LDL) or "bad" cholesterol and blood sugar and may help protect against heart attack and stroke.
The August issue of Mayo Clinic Health Letter explains how to boost soluble fiber in the diet.
Fiber comes in two forms -- soluble and insoluble. Soluble fiber dissolves in water to form a gel-like material. The recommended daily intake of total fiber for women over age 51 is 21 grams. For men over 51, it's 30 grams.
Fiber supplements, such as Metamucil, Konsyl and others, can boost soluble fiber intake. A typical dose has 2 to 3 grams. Other good sources include:
-- One-half cup of baked beans, cooked black beans, kidney, lima or navy beans provides about 1 gram of soluble fiber.
-- A pear, peach, plum or orange contains about 1 gram of soluble fiber.
-- An apple, mango, one-half of a grapefruit or one-half cup of blackberries each has about ?? gram of soluble fiber.
-- Certain vegetables, such as a medium carrot, one-half cup of cooked peas, broccoli or Brussels sprouts, or a medium cooked potato with its skin, contain about 1 gram of soluble fiber.
-- Oats, whether as one-half cup of oatmeal or oat bran or as an ounce of granola, are good for about 1 gram of soluble fiber.
-- Brewed coffee -- A recent analysis showed a cup of brewed coffee contains about 1 gram of soluble fiber.
Mayo Clinic
200 First St. SW
Rochester, MN 55902
United States
mayoclinic
The August issue of Mayo Clinic Health Letter explains how to boost soluble fiber in the diet.
Fiber comes in two forms -- soluble and insoluble. Soluble fiber dissolves in water to form a gel-like material. The recommended daily intake of total fiber for women over age 51 is 21 grams. For men over 51, it's 30 grams.
Fiber supplements, such as Metamucil, Konsyl and others, can boost soluble fiber intake. A typical dose has 2 to 3 grams. Other good sources include:
-- One-half cup of baked beans, cooked black beans, kidney, lima or navy beans provides about 1 gram of soluble fiber.
-- A pear, peach, plum or orange contains about 1 gram of soluble fiber.
-- An apple, mango, one-half of a grapefruit or one-half cup of blackberries each has about ?? gram of soluble fiber.
-- Certain vegetables, such as a medium carrot, one-half cup of cooked peas, broccoli or Brussels sprouts, or a medium cooked potato with its skin, contain about 1 gram of soluble fiber.
-- Oats, whether as one-half cup of oatmeal or oat bran or as an ounce of granola, are good for about 1 gram of soluble fiber.
-- Brewed coffee -- A recent analysis showed a cup of brewed coffee contains about 1 gram of soluble fiber.
Mayo Clinic
200 First St. SW
Rochester, MN 55902
United States
mayoclinic
Pomegranate Extract Stimulates Uterine Contractions
The team identified beta-sitosterol - a steroid that can inhibit the absorption of cholesterol in the intestine - as the main constituent of pomegranate seed extract. The research suggests that pomegranate extract could be used as a natural stimulant to encourage the uterus to contract during labour.
Pomegranate juice is thought to have a number of health benefits, from lowering cholesterol and blood pressure to protecting against some cancers, but until now there has been no evidence to demonstrate its effects on the uterus. Researchers investigated pomegranate seed extract - more highly concentrated than pomegranate juice - and its effect on uterine smooth muscle samples.
Professor Sue Wray, from the University's Department of Physiology, said: "Previous study has suggested that the pomegranate's antioxidant and anti-inflammatory properties have a positive impact on health. We wanted to understand its effect on uterine contractions to help us explore new ways of treating women who may experience difficult labours. Currently the only available drug to treat women with a poorly contracting uterus is oxytocin, a hormone which only works approximately 50% of the time.
"It is important for us to investigate how the uterus works and what happens when it does not contract normally so that women experiencing problems during labour do not have to undergo major surgery to deliver a healthy baby."
Dr Sajeera Kupittayanant, from Suranaree's Institute of Science, explains: "We found that beta-sitosterol was the main constituent of pomegranate extract, a steroid present in many plant species, but particularly rich in pomegranate seed. We added the extract to uterus tissue samples from animals and found that the muscle cells increased their activity. Our work suggests that the increase is due to a rise in calcium, which is necessary in order for any muscle to contract, but is usually affected by hormones, nerve impulses and some drug treatments.
"The next step is to investigate how beta-sitosterol in pomegranate extract could increase calcium, but it could prove to be a significant step forward in identifying new ways of treating dysfunctional labour."
The research, published in Reproductive Sciences, will support work being conducted at a new centre dedicated to improving experiences in pregnancy and childbirth for women across the world. The Centre for Better Births will bring together researchers and clinicians to improve understanding in areas such as premature labour, recurrent miscarriage and prolonged labour.
Advice to patients: Researchers used pomegranate seed extract, which is more highly concentrated than pomegranate juice. More research is needed to understand if eating the fruit or drinking its juice has any impact on uterine contractions.
Pomegranate juice is thought to have a number of health benefits, from lowering cholesterol and blood pressure to protecting against some cancers, but until now there has been no evidence to demonstrate its effects on the uterus. Researchers investigated pomegranate seed extract - more highly concentrated than pomegranate juice - and its effect on uterine smooth muscle samples.
Professor Sue Wray, from the University's Department of Physiology, said: "Previous study has suggested that the pomegranate's antioxidant and anti-inflammatory properties have a positive impact on health. We wanted to understand its effect on uterine contractions to help us explore new ways of treating women who may experience difficult labours. Currently the only available drug to treat women with a poorly contracting uterus is oxytocin, a hormone which only works approximately 50% of the time.
"It is important for us to investigate how the uterus works and what happens when it does not contract normally so that women experiencing problems during labour do not have to undergo major surgery to deliver a healthy baby."
Dr Sajeera Kupittayanant, from Suranaree's Institute of Science, explains: "We found that beta-sitosterol was the main constituent of pomegranate extract, a steroid present in many plant species, but particularly rich in pomegranate seed. We added the extract to uterus tissue samples from animals and found that the muscle cells increased their activity. Our work suggests that the increase is due to a rise in calcium, which is necessary in order for any muscle to contract, but is usually affected by hormones, nerve impulses and some drug treatments.
"The next step is to investigate how beta-sitosterol in pomegranate extract could increase calcium, but it could prove to be a significant step forward in identifying new ways of treating dysfunctional labour."
The research, published in Reproductive Sciences, will support work being conducted at a new centre dedicated to improving experiences in pregnancy and childbirth for women across the world. The Centre for Better Births will bring together researchers and clinicians to improve understanding in areas such as premature labour, recurrent miscarriage and prolonged labour.
Advice to patients: Researchers used pomegranate seed extract, which is more highly concentrated than pomegranate juice. More research is needed to understand if eating the fruit or drinking its juice has any impact on uterine contractions.
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