Isis
Pharmaceuticals, Inc. (Nasdaq: ISIS) today announced results of a study
showing that ISIS 301012 reduced atherosclerotic plaques, apoB-100, and
circulating inflammatory cytokines in an animal model of atherosclerosis.
These data support a growing body of evidence demonstrating that ISIS
301012 has the potential to treat patients with coronary artery disease.
Isis recently reported in a Phase 2 trial that ISIS 301012 produced rapid,
dose-dependent and prolonged reductions of its target, apoB-100, with
concomitant reductions in low density lipoprotein (LDL or "bad"
cholesterol), very low density lipoprotein (VLDL), total cholesterol and
triglyceride levels in patients with high cholesterol. ISIS 301012 is a
second-generation antisense drug that inhibits the expression of apoB-100,
a protein critical to the formation and transport of the "bad" cholesterol
particles involved in heart disease -- LDL and VLDL. Rosanne Crooke, Ph.D.,
Director of Cardiovascular Research of Isis Pharmaceuticals, presented
these data at the Arteriosclerosis, Thrombosis and Vascular Biology (ATVB)
meeting in Denver, Colorado.
ISIS 301012 was administered to mice that were bred to contain no LDL
receptor. These transgenic mice also expressed human apoB-100. In this
transgenic model, mice develop extensive atherosclerotic plaques. A 14-week
treatment with ISIS 301012 produced a dose-dependent reduction in apoB-100
levels, with concomitant decreases in aortic plaque volume. At 50 mg/kg/wk,
ISIS 301012 treatment reduced the levels of apoB-100 by 69% (p
ABOUT ISIS 301012
ISIS 301012 is a second-generation antisense drug that inhibits
apoB-100, a protein critical to the synthesis and transport of the "bad"
cholesterol involved in heart disease -- low density lipoprotein
cholesterol (LDL) and very low density lipoprotein (VLDL). Lowering
cholesterol and triglyceride levels is a key component in the prevention
and management of cardiovascular disease.
Development plans for ISIS 301012 include the rapid development of the
drug for patients with familial hypercholesterolemia (FH), a genetic
disorder that causes extremely high cholesterol levels and results in the
early onset of heart disease. ISIS 301012 has the potential for an
accelerated pathway to commercialization because of the unmet medical need
in this desperate patient population. Additional trials have been designed
to address the larger commercial market represented by the traditional
population of patients with high cholesterol who are still not reaching
their targeted cholesterol levels.
In September 2005, Isis initiated the Phase 2 development program of
ISIS 301012. Phase 2 trials of ISIS 301012 are being conducted in patients
with high cholesterol. Isis is continuing its Phase 2 single-agent trial
using higher dosing (300 and 400 mg/wk) of ISIS 301012 in patients with
high cholesterol. Isis is also conducting a Phase 2 trial of ISIS 301012 in
combination with statin therapy in patients with high cholesterol. Isis is
also conducting Phase 2 studies of ISIS 301012 in FH.
Isis recently reported initial data from the low-dose cohorts of a
Phase 2 clinical trial of ISIS 301012 as a single-agent in patients with
high cholesterol. ISIS 301012 produced rapid, dose-dependent and prolonged
reductions of its target, apoB-100, with concomitant reductions in LDL,
VLDL, total cholesterol and triglyceride levels in patients with high
cholesterol. In Phase 1 trials, ISIS 301012 produced rapid, dose-dependent
and prolonged reductions of its target, apoB-100, with concomitant
reductions in LDL, VLDL, total cholesterol and triglycerides in normal
subjects with elevated cholesterol. In a drug-drug interaction study, ISIS
301012 did not interact with simvastatin or ezetimibe, currently available
lipid lowering drugs with which ISIS 301012 may be dosed in combination.
Additionally, the drug has been well tolerated.
ABOUT CHOLESTEROL AND CARDIOVASCULAR DISEASE
According to the American Heart Association, an estimated 107 million
American adults have total blood cholesterol values of 200 mg/dL and
higher, and of these about 38 million American adults have levels of 240 or
above. In adults, total cholesterol levels of 240 mg/dL or higher are
considered "high risk". Levels from 200 to 239 mg/dL are considered
"borderline-high risk". Low-density lipoprotein, or LDL, known as the "bad"
cholesterol, can clog arteries, increasing the risk of heart attack and
stroke.
According to the World Health Organization (WHO), heart disease and
stroke kill 17 million people a year, which is almost one-third of all
deaths globally. By 2020, the WHO projects that heart disease and stroke
will become the leading cause of both death and disability worldwide, with
the number of fatalities projected to increase to over 20 million a year
and by 2030 to over 24 million a year.
Familial hypercholesterolemia is a dominantly inherited genetic
condition that results in markedly elevated LDL (low-density lipoprotein)
cholesterol levels beginning at birth, and resulting in heart attacks at an
early age. Affected people have consistently high levels of low-density
lipoprotein, which leads to premature atherosclerosis of the coronary
arteries.
ABOUT ISIS' SYMPHONY GENISIS COLLABORATION
In April 2006, Isis entered into a collaboration with Symphony Capital
Partners, L.P. and a group of co-investors to form Symphony GenIsis, Inc.,
capitalized with $75 million, to fund the development of Isis'
cholesterol-lowering drug, ISIS 301012, and two novel drugs from Isis'
metabolic disease program. Isis licensed to Symphony GenIsis the
intellectual property for its apoB-100, glucagon receptor and
glucocorticoid receptor programs. The financing will support Isis'
development of ISIS 301012 through the completion of
registration-supporting clinical studies in patients with familial
hypercholesterolemia and the completion of Phase 2b clinical trials in
patients with high cholesterol. The financing will also support Isis'
development of two novel diabetes drugs through initial proof of concept in
human clinical trials. In addition to providing the financial support to
move these drugs forward aggressively, the transaction allows Isis to
continue to control and manage the development of ISIS 301012 and two other
potentially valuable drugs through key development milestones.
ABOUT ISIS PHARMACEUTICALS, INC.
Isis is exploiting its expertise in RNA to discover and develop novel
drugs for its product pipeline and for its partners. The Company has
successfully commercialized the world's first antisense drug and has 15
drugs in development. Isis' drug development programs are aimed at treating
cardiovascular, metabolic and inflammatory diseases. Isis' partners are
focused in disease areas such as inflammatory, ocular, viral and
neurodegenerative diseases, and cancer. In its Ibis division, Isis is
developing and commercializing the IBIS biosensor system, a revolutionary
system to identify infectious organisms. As an innovator in RNA-based drug
discovery and development, Isis is the owner or exclusive licensee of
approximately 1,500 issued patents worldwide. Additional information about
Isis is available at isispharm
.
This press release includes forward-looking statements regarding the
development, therapeutic potential and safety profile of ISIS 301012 for
the treatment of high cholesterol and cardiovascular disease. Any statement
describing Isis' goals, expectations, intentions or beliefs is a
forward-looking statement and should be considered an at-risk statement,
including those statements that are described as Isis' goals. Such
statements are subject to certain risks and uncertainties, particularly
those inherent in the process of discovering, developing and
commercializing drugs that are safe and effective for use as human
therapeutics, and in the endeavor of building a business around such
products. Isis' forward-looking statements also involve assumptions that,
if they never materialize or prove correct, could cause its results to
differ materially from those expressed or implied by such forward-looking
statements. Although Isis' forward-looking statements reflect the good
faith judgment of its management, these statements are based only on facts
and factors currently known by Isis. As a result, you are cautioned not to
rely on these forward-looking statements. These and other risks concerning
Isis' programs are described in additional detail in Isis' annual report on
Form 10-K for the year ended December 31, 2005, which is on file with the
U.S. Securities and Exchange Commission (SEC) and available from the
Company.
Isis Pharmaceuticals, Inc.
isispharm
View drug information on Glucagon.
вторник, 30 августа 2011 г.
суббота, 27 августа 2011 г.
The Facts About Soy Protein And Heart Health
Recent controversy has surfaced regarding the efficacy of soy protein consumption in reducing serum cholesterol. Of primary concern is whether a 1995 meta-analysis (which generated considerable excitement in the medical community) accurately estimated the impact of soy consumption on cholesterol lowering. Following are the facts you should know about soy and heart health.
FACT: Experts agree soy protein lowers cholesterol
A 2006 American Heart Association (AHA) research review found that soy protein lowers blood cholesterol above and beyond that realized from a low fat, low cholesterol diet. This finding is consistent with the U.S. Food and Drug Administration (FDA) recognizing that soy protein lowers cholesterol by between 3 and 8 percent.
FACT: Experts agree soy has additional heart health benefits
The AHA report noted that soy foods are heart healthy because of their high content of polyunsaturated fats, fiber, vitamins, minerals and low content of saturated fat, making them an ideal substitute for less healthy foods that are high in saturated fat and cholesterol. The FDA and, similarly, the AHA have agreed that soy foods appear to modestly lower triglycerides and raise HDL ("Good") blood cholesterol levels.
FACT: Eight governments recognize the heart health benefits of soy
Authorities around the world have approved health claims supporting the consumption of soy protein and a lowering of blood cholesterol, including the USA, Korea, Japan, Brazil, Philippines, Indonesia, Malaysia and the United Kingdom. These claims were approved based on an extensive review of scientific literature to determine that the relationship between soy protein and lowered cholesterol was well established. It's the weight of this scientific evidence that led so many government health authorities to approve soy/heart health claims.
FACT: Soy protein is a food, not a prescription drug
Soy foods have the unique ability to both lower LDL ("Bad") cholesterol and lower triglycerides, but not to the degree expected from cholesterol-lowering medications. That soy products have been found to lower blood cholesterol even a small amount, however, has the potential to dramatically impact public health. One may argue whether a 3 8 percent reduction in cholesterol is "clinically significant," but the bottom line is that heart disease prevention depends on small life changes. Neither pharmaceuticals nor soy foods are by themselves panaceas for a healthy heart.
Solae Company
PO Box 88940
St. Louis, MO 63188
United States
solae
FACT: Experts agree soy protein lowers cholesterol
A 2006 American Heart Association (AHA) research review found that soy protein lowers blood cholesterol above and beyond that realized from a low fat, low cholesterol diet. This finding is consistent with the U.S. Food and Drug Administration (FDA) recognizing that soy protein lowers cholesterol by between 3 and 8 percent.
FACT: Experts agree soy has additional heart health benefits
The AHA report noted that soy foods are heart healthy because of their high content of polyunsaturated fats, fiber, vitamins, minerals and low content of saturated fat, making them an ideal substitute for less healthy foods that are high in saturated fat and cholesterol. The FDA and, similarly, the AHA have agreed that soy foods appear to modestly lower triglycerides and raise HDL ("Good") blood cholesterol levels.
FACT: Eight governments recognize the heart health benefits of soy
Authorities around the world have approved health claims supporting the consumption of soy protein and a lowering of blood cholesterol, including the USA, Korea, Japan, Brazil, Philippines, Indonesia, Malaysia and the United Kingdom. These claims were approved based on an extensive review of scientific literature to determine that the relationship between soy protein and lowered cholesterol was well established. It's the weight of this scientific evidence that led so many government health authorities to approve soy/heart health claims.
FACT: Soy protein is a food, not a prescription drug
Soy foods have the unique ability to both lower LDL ("Bad") cholesterol and lower triglycerides, but not to the degree expected from cholesterol-lowering medications. That soy products have been found to lower blood cholesterol even a small amount, however, has the potential to dramatically impact public health. One may argue whether a 3 8 percent reduction in cholesterol is "clinically significant," but the bottom line is that heart disease prevention depends on small life changes. Neither pharmaceuticals nor soy foods are by themselves panaceas for a healthy heart.
Solae Company
PO Box 88940
St. Louis, MO 63188
United States
solae
среда, 24 августа 2011 г.
Trans Fat Ban: Watch Saturated Fats And Calories Too
In December, New York City passed a law to phase out the use of trans fat in restaurants. Other cities, including Boston and Chicago, might follow suit. According to Alice H. Lichtenstein, DSc, Gershoff professor of nutrition science and policy at the Friedman School of Nutrition Science and Policy at Tufts University, the ban is a step in the right direction, but restaurateurs need to replace partially hydrogenated fat with unsaturated fat. If they choose saturated fat it would diminish the health benefits of this new initiative. Another new regulation that requires some restaurants to provide calorie information as prominently as price might be even more important, notes Lichtenstein.
"There is no biological need for trans fat and intake is associated with adverse health outcomes. However, the media attention on the trans fat announcement to the exclusion of the calorie labeling is unfortunate. Two-thirds of Americans are overweight or obese. The New York City Department of Health and Mental Hygiene has proposed that the calorie content of food items be displayed as prominently as the price, at the point of purchase," says Lichtenstein, also director of the Cardiovascular Nutrition Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts.
"That means," Lichtenstein continues, "that if you are wavering between placing an order for a small versus a medium order of French fries, both the price and the number of calories per serving will be displayed. People will become more aware of the caloric cost of the foods they order, and the next step on a public health level would be to educate the consumer on the amount of calories their body needs per day. This way, they will be able to put the numbers they see on the board or menu into perspective. Because the amount of food and beverages we eat that is prepared outside the home is so large, even if this regulation just covers a fraction of food service establishments, it can have a tremendous impact on caloric intake."
"Trans fat," says Lichtenstein, "is a double whammy, because like saturated fat, it raises levels of LDL or ???bad cholesterol,??™ but it also lowers levels of HDL or ???good??™ cholesterol." Most of the trans fats we eat are formed during the partial hydrogenation of oils used in fried foods and commercial baked goods. Partially hydrogenated oils provide processed foods with longer shelf lives and therefore greater economic profitability.
"But, trans fat is just one part of the diet. In general, people are still eating far more saturated fat than trans fat, and both need to be reduced in order to maintain optimal cholesterol levels and promote heart health," says Lichtenstein. "And the big giant ???" total calories ???" is always looming in the background."
In one study to assess the effects of consuming different types of oils on cholesterol levels, led by Lichtenstein and published earlier this year, fifteen adult volunteers with moderately high LDL cholesterol were fed each of four diets with a different source of primary fat, including partially hydrogenated soybean oil (trans fat), palm oil (50 percent saturated fat), non-hydrogenated soybean oil (only 16 percent saturated fat), and canola oil (only 7 percent saturated fat).
The results, published in the American Journal of Clinical Nutrition (AJCN), reported that after a trial of 35 days on each diet, participants consuming the partially hydrogenated soybean oil and palm oil diets had levels of LDL cholesterol that were 12 and 14 percent higher, respectively, than when consuming the non-hydrogenated soybean oil diet. An even greater difference was observed when the partially hydrogenated soybean oil and palm oil diets were compared to the canola oil diet. While participants were on the partially hydrogenated soybean oil and palm oil diets their LDL levels were 16 and 18 percent higher, respectively, than when on the canola oil diet.
"On the basis of this and other work, it??™s clear that phasing out partially hydrogenated oils (trans fats) will improve diet in some ways", says Lichtenstein, corresponding author on the AJCN study. "However, just decreasing trans fat intake without changing other dietary habits, such as minimizing saturated fat intake and controlling total calorie intake, will result in some real disappointments with respect to both heart health and obesity."
Lichtenstein recommends that other cities monitor the successes and challenges of the trans fat ban in New York City before implementing their own regulations, and also advises that the focus on the new regulations shift to the mandate to display calorie labeling in food service establishments, and educating people about their total daily caloric requirements.
Vega-Lopez S, Ausman LM, Jalbert SM, Erkkila AT, Lichtenstein AH. ???Palm and partially hydrogenated soybean oils adversely alter lipoprotein profiles compared with soybean and canola oils in moderately hyperlipidemic subjects.??? American Journal of Clinical Nutrition. 2006 (July);84(1):54-62.
The Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy at Tufts University is the only independent school of nutrition in the United States. The school??™s eight centers, which focus on questions relating to famine, hunger, poverty, and communications, are renowned for the application of scientific research to national and international policy. For two decades, the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University has studied the relationship between good nutrition and good health in aging populations. Tufts research scientists work with federal agencies to establish the USDA Dietary Guidelines, the Dietary Reference Intakes, and other significant public policies.
Tufts University
Medford Somerville, MA
United States
Tufts University
"There is no biological need for trans fat and intake is associated with adverse health outcomes. However, the media attention on the trans fat announcement to the exclusion of the calorie labeling is unfortunate. Two-thirds of Americans are overweight or obese. The New York City Department of Health and Mental Hygiene has proposed that the calorie content of food items be displayed as prominently as the price, at the point of purchase," says Lichtenstein, also director of the Cardiovascular Nutrition Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts.
"That means," Lichtenstein continues, "that if you are wavering between placing an order for a small versus a medium order of French fries, both the price and the number of calories per serving will be displayed. People will become more aware of the caloric cost of the foods they order, and the next step on a public health level would be to educate the consumer on the amount of calories their body needs per day. This way, they will be able to put the numbers they see on the board or menu into perspective. Because the amount of food and beverages we eat that is prepared outside the home is so large, even if this regulation just covers a fraction of food service establishments, it can have a tremendous impact on caloric intake."
"Trans fat," says Lichtenstein, "is a double whammy, because like saturated fat, it raises levels of LDL or ???bad cholesterol,??™ but it also lowers levels of HDL or ???good??™ cholesterol." Most of the trans fats we eat are formed during the partial hydrogenation of oils used in fried foods and commercial baked goods. Partially hydrogenated oils provide processed foods with longer shelf lives and therefore greater economic profitability.
"But, trans fat is just one part of the diet. In general, people are still eating far more saturated fat than trans fat, and both need to be reduced in order to maintain optimal cholesterol levels and promote heart health," says Lichtenstein. "And the big giant ???" total calories ???" is always looming in the background."
In one study to assess the effects of consuming different types of oils on cholesterol levels, led by Lichtenstein and published earlier this year, fifteen adult volunteers with moderately high LDL cholesterol were fed each of four diets with a different source of primary fat, including partially hydrogenated soybean oil (trans fat), palm oil (50 percent saturated fat), non-hydrogenated soybean oil (only 16 percent saturated fat), and canola oil (only 7 percent saturated fat).
The results, published in the American Journal of Clinical Nutrition (AJCN), reported that after a trial of 35 days on each diet, participants consuming the partially hydrogenated soybean oil and palm oil diets had levels of LDL cholesterol that were 12 and 14 percent higher, respectively, than when consuming the non-hydrogenated soybean oil diet. An even greater difference was observed when the partially hydrogenated soybean oil and palm oil diets were compared to the canola oil diet. While participants were on the partially hydrogenated soybean oil and palm oil diets their LDL levels were 16 and 18 percent higher, respectively, than when on the canola oil diet.
"On the basis of this and other work, it??™s clear that phasing out partially hydrogenated oils (trans fats) will improve diet in some ways", says Lichtenstein, corresponding author on the AJCN study. "However, just decreasing trans fat intake without changing other dietary habits, such as minimizing saturated fat intake and controlling total calorie intake, will result in some real disappointments with respect to both heart health and obesity."
Lichtenstein recommends that other cities monitor the successes and challenges of the trans fat ban in New York City before implementing their own regulations, and also advises that the focus on the new regulations shift to the mandate to display calorie labeling in food service establishments, and educating people about their total daily caloric requirements.
Vega-Lopez S, Ausman LM, Jalbert SM, Erkkila AT, Lichtenstein AH. ???Palm and partially hydrogenated soybean oils adversely alter lipoprotein profiles compared with soybean and canola oils in moderately hyperlipidemic subjects.??? American Journal of Clinical Nutrition. 2006 (July);84(1):54-62.
The Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy at Tufts University is the only independent school of nutrition in the United States. The school??™s eight centers, which focus on questions relating to famine, hunger, poverty, and communications, are renowned for the application of scientific research to national and international policy. For two decades, the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University has studied the relationship between good nutrition and good health in aging populations. Tufts research scientists work with federal agencies to establish the USDA Dietary Guidelines, the Dietary Reference Intakes, and other significant public policies.
Tufts University
Medford Somerville, MA
United States
Tufts University
воскресенье, 21 августа 2011 г.
Risk For High-Grade Prostate Cancer May Be Reduced By Low Cholesterol
Men with lower cholesterol are less likely than those with higher levels to develop high-grade prostate cancer - an aggressive form of the disease with a poorer prognosis, according to results of a Johns Hopkins collaborative study.
In a prospective study of more than 5,000 U.S. men, epidemiologists say they now have evidence that having lower levels of heart-clogging fat may cut a man's risk of this form of cancer by nearly 60 percent.
"For many reasons, we know that it's good to have a cholesterol level within the normal range," says Elizabeth Platz, Sc.D., M.P.H., associate professor at the Johns Hopkins Bloomberg School of Public Health and co-director of the cancer prevention and control program at the Johns Hopkins Kimmel Cancer Center. "Now, we have more evidence that among the benefits of low cholesterol may be a lower risk for potentially deadly prostate cancers."
Normal range is defined as less than 200 mg/dL (milligrams per deciliter of blood) of total cholesterol.
Platz and her colleagues found similar results in a study first published in 2008, and in 2006, she linked use of cholesterol-lowering statin drugs to lower risk of advanced prostate cancer.
For the current study, Platz, members of the Southwest Oncology Group, and other collaborators analyzed data from 5,586 men aged 55 and older enrolled in the Prostate Cancer Prevention Trial from 1993 to 1996. Some 1,251 men were diagnosed with prostate cancer during the study period.
Men with cholesterol levels lower than 200 mg/dL had a 59 percent lower risk of developing high-grade prostate cancers, which tend to grow and spread rapidly. High-grade cancers are identified by a pathological ranking called the Gleason score. Scores at the highest end of the scale, between eight and 10, indicate cancers considered the most worrisome to pathologists who examine samples of the diseased prostate under the microscope.
In Platz's study, cholesterol levels had no significant effect on the entire spectrum of prostate cancer incidence, only those that were high-grade, she says.
Platz cautions that, while the group took into account factors that could bias the results, such as smoking history, weight, family history of prostate cancer, and dietary cholesterol, other things could have affected their results. One example is whether men in the study were taking cholesterol-lowering drugs at the time of the blood collections, a data point the researchers expect to analyze soon.
Results of the current study are expected to be published online Nov. 3 in the journal Cancer Epidemiology, Biomarkers & Prevention. Also in the journal is an accompanying paper from the National Cancer Institute showing that lower cholesterol in men conferred a 15 percent decrease in overall cancer cases.
"Cholesterol may affect cancer cells at a level where it influences key signaling pathways controlling cell survival," says Platz. "Cancer cells use these survival pathways to evade the normal cycle of cell life and death."
She says that targeting cholesterol metabolism may be one route to treating and preventing the disease, but this remains to be tested.
Funding for the study was provided by the National Cancer Institute.
Authors of the study include Cathee Till, Phyllis J. Goodman, Marian L. Neuhouser and Alan R. Kristal from the Fred Hutchinson Cancer Research Center; Howard L. Parnes, William D. Figg, and Demetrius Albanes from the National Cancer Institute; Eric A. Klein from the Cleveland Clinic; and Ian M. Thompson Jr., from the University of Texas Health Sciences Center.
In a prospective study of more than 5,000 U.S. men, epidemiologists say they now have evidence that having lower levels of heart-clogging fat may cut a man's risk of this form of cancer by nearly 60 percent.
"For many reasons, we know that it's good to have a cholesterol level within the normal range," says Elizabeth Platz, Sc.D., M.P.H., associate professor at the Johns Hopkins Bloomberg School of Public Health and co-director of the cancer prevention and control program at the Johns Hopkins Kimmel Cancer Center. "Now, we have more evidence that among the benefits of low cholesterol may be a lower risk for potentially deadly prostate cancers."
Normal range is defined as less than 200 mg/dL (milligrams per deciliter of blood) of total cholesterol.
Platz and her colleagues found similar results in a study first published in 2008, and in 2006, she linked use of cholesterol-lowering statin drugs to lower risk of advanced prostate cancer.
For the current study, Platz, members of the Southwest Oncology Group, and other collaborators analyzed data from 5,586 men aged 55 and older enrolled in the Prostate Cancer Prevention Trial from 1993 to 1996. Some 1,251 men were diagnosed with prostate cancer during the study period.
Men with cholesterol levels lower than 200 mg/dL had a 59 percent lower risk of developing high-grade prostate cancers, which tend to grow and spread rapidly. High-grade cancers are identified by a pathological ranking called the Gleason score. Scores at the highest end of the scale, between eight and 10, indicate cancers considered the most worrisome to pathologists who examine samples of the diseased prostate under the microscope.
In Platz's study, cholesterol levels had no significant effect on the entire spectrum of prostate cancer incidence, only those that were high-grade, she says.
Platz cautions that, while the group took into account factors that could bias the results, such as smoking history, weight, family history of prostate cancer, and dietary cholesterol, other things could have affected their results. One example is whether men in the study were taking cholesterol-lowering drugs at the time of the blood collections, a data point the researchers expect to analyze soon.
Results of the current study are expected to be published online Nov. 3 in the journal Cancer Epidemiology, Biomarkers & Prevention. Also in the journal is an accompanying paper from the National Cancer Institute showing that lower cholesterol in men conferred a 15 percent decrease in overall cancer cases.
"Cholesterol may affect cancer cells at a level where it influences key signaling pathways controlling cell survival," says Platz. "Cancer cells use these survival pathways to evade the normal cycle of cell life and death."
She says that targeting cholesterol metabolism may be one route to treating and preventing the disease, but this remains to be tested.
Funding for the study was provided by the National Cancer Institute.
Authors of the study include Cathee Till, Phyllis J. Goodman, Marian L. Neuhouser and Alan R. Kristal from the Fred Hutchinson Cancer Research Center; Howard L. Parnes, William D. Figg, and Demetrius Albanes from the National Cancer Institute; Eric A. Klein from the Cleveland Clinic; and Ian M. Thompson Jr., from the University of Texas Health Sciences Center.
четверг, 18 августа 2011 г.
About 63% Of U.S. Women Concerned About High Cholesterol; Only 32% Know Their Number, Survey Finds
About 63% of U.S. women are concerned about high cholesterol, but only 32% know their cholesterol number, according to a nationwide survey released Tuesday by the Society for Women's Health Research, United Press International reports (United Press International, 8/21).
According to a SWHR release, the firm GfK Custom Research North America conducted the telephone survey of 524 women from June 29 to July 1. The survey found that nearly 88% of the women know that high cholesterol is linked to hardening of the arteries and heart disease, and almost 85% know high cholesterol can lead to stroke. However, only 50% of the women reported receiving a cholesterol test in the past year (SWHR release, 8/21). About 60% of women surveyed said they actively were trying to manage their cholesterol (Soltis, New York Post, 8/22).
According to the survey, only 35% of the women knew any of the four numbers for monitoring cholesterol: total cholesterol level, low density lipoprotein, high density lipoprotein and triglyceride level. Nearly all women know that exercise can help fight high cholesterol, and about 95% know that eating more fruits and vegetables and less high-fat foods can help heart health, the survey found (United Press International, 8/21).
"Clearly, strides have been made in educating women on the risks of high cholesterol, but the disconnect between awareness and action needs to be addressed," Phyllis Greenberger, president and CEO of SWHR, said, adding, "Knowing your cholesterol number is the first step in controlling cholesterol" (SWHR release, 8/21).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
According to a SWHR release, the firm GfK Custom Research North America conducted the telephone survey of 524 women from June 29 to July 1. The survey found that nearly 88% of the women know that high cholesterol is linked to hardening of the arteries and heart disease, and almost 85% know high cholesterol can lead to stroke. However, only 50% of the women reported receiving a cholesterol test in the past year (SWHR release, 8/21). About 60% of women surveyed said they actively were trying to manage their cholesterol (Soltis, New York Post, 8/22).
According to the survey, only 35% of the women knew any of the four numbers for monitoring cholesterol: total cholesterol level, low density lipoprotein, high density lipoprotein and triglyceride level. Nearly all women know that exercise can help fight high cholesterol, and about 95% know that eating more fruits and vegetables and less high-fat foods can help heart health, the survey found (United Press International, 8/21).
"Clearly, strides have been made in educating women on the risks of high cholesterol, but the disconnect between awareness and action needs to be addressed," Phyllis Greenberger, president and CEO of SWHR, said, adding, "Knowing your cholesterol number is the first step in controlling cholesterol" (SWHR release, 8/21).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
понедельник, 15 августа 2011 г.
Protein controls metabolism and circadian rhythms - U of T research
University of Toronto researchers have gained new insight into how a specific protein may control circadian rhythms and metabolic processes, which has implications for treating cholesterol-related diseases.
U of T professor Henry Krause and his colleagues have identified heme, an iron compound, best known for its oxygen carrying capabilities in hemoglobin, as the molecule that allows the protein E75 to regulate a number of key developmental processes. In a paper published in the July 29 issue of Cell, the researchers use fruit flies to show that heme attaches itself to E75, allowing the protein to respond to a variety of cellular signals necessary for controlling systemic processes such as metabolism and circadian rhythms, the human body's clock.
Since the human body contains a nuclear hormone receptor comparable to E75, the research is an important first step to understanding how people metabolize fat, how their circadian rhythms are regulated and how their bodies age. The researchers studied fruit flies, because they have many genes similar to those found in humans and they reproduce rapidly.
"The important role heme plays in the body's smooth operation has been previously identified, but it was quite unexpected to find it binding to a member of the nuclear hormone receptor family of proteins," says Krause, a professor in the Banting and Best Department of Medical Research and the Department of Medical Genetics and Microbiology."
There are practical reasons for exploring the relationship between heme and E75, says Krause, whose lab purified the protein, then used mass spectrometry to analyze it. About 15 per cent of successful drugs on the market target nuclear hormone receptors like E75.
"In addition to finding out how E75 and its human counterpart control metabolic processes, and learning how to control these functions, it should also help us to discover the other hormones that control the rest of this nuclear hormone receptor family," says Krause. As they are identified, new drugs can be designed to control the many metabolic diseases, such as high cholesterol, associated with the malfunction of these proteins.
Other researchers involved in this study include U of T professor Aled Edwards, head of the Structural Genomics Consortium; U of T post-doctoral student Jeff Reinking, master's degree holder Mandy Lam, doctoral students Keith Pardee and Heidi Sampson and post-doctoral fellow Ping Yang; researchers Shawn Williams and Wendy White from GlaxoSmithKline; and technician Suya Liu and Professor Gilles Lajoie from the University of Western Ontario.
The study was funded by the Canadian Institutes of Health Research and GlaxoSmithKline.
CONTACT:
Elaine Smith
U of T Public Affairs
416-978-5948
elaine.smithutoronto.ca
Henry Krause
h.krauseutoronto.ca
416-978-8602
University of Toronto
utoronto.ca
U of T professor Henry Krause and his colleagues have identified heme, an iron compound, best known for its oxygen carrying capabilities in hemoglobin, as the molecule that allows the protein E75 to regulate a number of key developmental processes. In a paper published in the July 29 issue of Cell, the researchers use fruit flies to show that heme attaches itself to E75, allowing the protein to respond to a variety of cellular signals necessary for controlling systemic processes such as metabolism and circadian rhythms, the human body's clock.
Since the human body contains a nuclear hormone receptor comparable to E75, the research is an important first step to understanding how people metabolize fat, how their circadian rhythms are regulated and how their bodies age. The researchers studied fruit flies, because they have many genes similar to those found in humans and they reproduce rapidly.
"The important role heme plays in the body's smooth operation has been previously identified, but it was quite unexpected to find it binding to a member of the nuclear hormone receptor family of proteins," says Krause, a professor in the Banting and Best Department of Medical Research and the Department of Medical Genetics and Microbiology."
There are practical reasons for exploring the relationship between heme and E75, says Krause, whose lab purified the protein, then used mass spectrometry to analyze it. About 15 per cent of successful drugs on the market target nuclear hormone receptors like E75.
"In addition to finding out how E75 and its human counterpart control metabolic processes, and learning how to control these functions, it should also help us to discover the other hormones that control the rest of this nuclear hormone receptor family," says Krause. As they are identified, new drugs can be designed to control the many metabolic diseases, such as high cholesterol, associated with the malfunction of these proteins.
Other researchers involved in this study include U of T professor Aled Edwards, head of the Structural Genomics Consortium; U of T post-doctoral student Jeff Reinking, master's degree holder Mandy Lam, doctoral students Keith Pardee and Heidi Sampson and post-doctoral fellow Ping Yang; researchers Shawn Williams and Wendy White from GlaxoSmithKline; and technician Suya Liu and Professor Gilles Lajoie from the University of Western Ontario.
The study was funded by the Canadian Institutes of Health Research and GlaxoSmithKline.
CONTACT:
Elaine Smith
U of T Public Affairs
416-978-5948
elaine.smithutoronto.ca
Henry Krause
h.krauseutoronto.ca
416-978-8602
University of Toronto
utoronto.ca
пятница, 12 августа 2011 г.
Nearly Half Of Statin-Treated Patients Not Currently Reaching LDL-C Target
Almost half (48%) of statin-treated patients are not meeting target levels of low-density lipoprotein cholesterol (LDL-C), according to the results of a new international study, conducted by Merck Sharp & Dohme Limited and presented today at the European Society of Cardiology (ESC) congress in Barcelona, Spain.1 Additionally, nearly three-quarters (73%) of the same patients had at least one lipid abnormality across LDL-C, HDL-C and triglyceride levels.1 In a separate UK survey, results have also shown a need for improving education of the public around how to proactively manage their lipid levels.2
The DYSlipidemia International Study (DYSIS) was a large study involving 22,000 statin-treated patients, extending across 12 countries in Europe and Canada. 28 centres were involved from the UK.1 Patients were aged 45 and older, had been on statin-treatment for three months or more, and had other cardiovascular conditions, including high blood pressure, diabetes, family history of premature CV disease or had coronary heart disease, among others.1 The study assessed the prevalence of LDL-C, HDL-C and triglyceride levels according to lipid goals in ESC guidelines.1
The DYSIS results showed that even in those patients reaching their LDL-C target, 25% still had abnormal levels of triglycerides and/or HDL-C.1 Additionally, 38% of the study population had elevated triglyceride levels, and 26% had HDL-C levels below target.1
"Although statins have represented a considerable advancement in cardiovascular disease prevention, the DYSIS results indicate that clinicians must continue to monitor their patients' lipid levels closely, including LDL-C, HDL-C and triglyceride levels," said Professor David Wood Lead UK investigator and Professor of Cardiovascular Medicine at Imperial College London, and Honorary Consultant Cardiologist at Imperial College Healthcare NHS Trust. He continued: "Many patients could benefit from additional management in order to further reduce their risk of cardiovascular disease, achieved through improved adherence, lifestyle changes, or further drug intervention."
In conjunction with the release of the DYSIS data, MSD UK announced findings from a UK-wide survey of over 2000 people. According to the survey:2
- the majority of people (85%) in the UK now know that cardiovascular disease is the leading cause of death in the UK and many are aware of LDL-C ('bad' cholesterol) and HDL-C ('good' cholesterol) (71% and 59% respectively).
- Despite this wide awareness, many did not know 'how to change' their LDL-C (57%) or HDL-C (74%).
- Furthermore, only around one third (36%) had heard of 'triglycerides', with most (77%) thinking triglycerides should be raised rather than reduced and 90% not knowing how to change them.
Dr Marc Evans, Consultant Diabetologist at Llandough Hospital in Wales commented: "DYSIS highlights that a significant CVD risk can remain for some patients." He continued: "A comprehensive approach that addresses HDL-C and triglycerides as well as LDL-C levels may be beneficial in these cases. This can be particularly important for patients who are at high risk of CVD such as secondary prevention patients, people with diabetes and South Asian populations. The UK survey of the general public also highlighted the need for educating people about the three lipids - this is essential if we want the public to become engaged in their own health."
About DYSIS1
DYSIS is an epidemiological study designed to examine the lipid profile of statin-treated patients (n=22,000) in an out-patient setting. Patients were enrolled from treatment centres across Austria, Canada, Denmark, France, Germany, Ireland, the Netherlands, Norway, Portugal, Spain, Sweden and the United Kingdom.
Patients were eligible for inclusion if they had been on statin therapy for at least three months prior to the time of assessment, aged ?‰?45 years, and had at least one lipid parameter available in their chart while receiving statin therapy. Patients were recruited by primary and secondary care physicians. All patients had a clinical examination and their latest lipid values were recorded.
About the UK-wide public survey2
This survey was conducted by Opinion Matters on behalf of Merck, Sharp & Dohme Ltd. The fieldwork was conducted via an online questionnaire between 27th July and 10th August 2009. The sample consisted of 2140 UK adults.
Source
Merck Sharp & Dohme Limited
The DYSlipidemia International Study (DYSIS) was a large study involving 22,000 statin-treated patients, extending across 12 countries in Europe and Canada. 28 centres were involved from the UK.1 Patients were aged 45 and older, had been on statin-treatment for three months or more, and had other cardiovascular conditions, including high blood pressure, diabetes, family history of premature CV disease or had coronary heart disease, among others.1 The study assessed the prevalence of LDL-C, HDL-C and triglyceride levels according to lipid goals in ESC guidelines.1
The DYSIS results showed that even in those patients reaching their LDL-C target, 25% still had abnormal levels of triglycerides and/or HDL-C.1 Additionally, 38% of the study population had elevated triglyceride levels, and 26% had HDL-C levels below target.1
"Although statins have represented a considerable advancement in cardiovascular disease prevention, the DYSIS results indicate that clinicians must continue to monitor their patients' lipid levels closely, including LDL-C, HDL-C and triglyceride levels," said Professor David Wood Lead UK investigator and Professor of Cardiovascular Medicine at Imperial College London, and Honorary Consultant Cardiologist at Imperial College Healthcare NHS Trust. He continued: "Many patients could benefit from additional management in order to further reduce their risk of cardiovascular disease, achieved through improved adherence, lifestyle changes, or further drug intervention."
In conjunction with the release of the DYSIS data, MSD UK announced findings from a UK-wide survey of over 2000 people. According to the survey:2
- the majority of people (85%) in the UK now know that cardiovascular disease is the leading cause of death in the UK and many are aware of LDL-C ('bad' cholesterol) and HDL-C ('good' cholesterol) (71% and 59% respectively).
- Despite this wide awareness, many did not know 'how to change' their LDL-C (57%) or HDL-C (74%).
- Furthermore, only around one third (36%) had heard of 'triglycerides', with most (77%) thinking triglycerides should be raised rather than reduced and 90% not knowing how to change them.
Dr Marc Evans, Consultant Diabetologist at Llandough Hospital in Wales commented: "DYSIS highlights that a significant CVD risk can remain for some patients." He continued: "A comprehensive approach that addresses HDL-C and triglycerides as well as LDL-C levels may be beneficial in these cases. This can be particularly important for patients who are at high risk of CVD such as secondary prevention patients, people with diabetes and South Asian populations. The UK survey of the general public also highlighted the need for educating people about the three lipids - this is essential if we want the public to become engaged in their own health."
About DYSIS1
DYSIS is an epidemiological study designed to examine the lipid profile of statin-treated patients (n=22,000) in an out-patient setting. Patients were enrolled from treatment centres across Austria, Canada, Denmark, France, Germany, Ireland, the Netherlands, Norway, Portugal, Spain, Sweden and the United Kingdom.
Patients were eligible for inclusion if they had been on statin therapy for at least three months prior to the time of assessment, aged ?‰?45 years, and had at least one lipid parameter available in their chart while receiving statin therapy. Patients were recruited by primary and secondary care physicians. All patients had a clinical examination and their latest lipid values were recorded.
About the UK-wide public survey2
This survey was conducted by Opinion Matters on behalf of Merck, Sharp & Dohme Ltd. The fieldwork was conducted via an online questionnaire between 27th July and 10th August 2009. The sample consisted of 2140 UK adults.
Source
Merck Sharp & Dohme Limited
вторник, 9 августа 2011 г.
Cholesterol Control Plus Blood Pressure Control Equals Stroke Prevention
Reaching optimal levels for cholesterol and high blood pressure in people who've had a stroke adds up to prevent a second stroke or heart attack, according to a study presented as part of the Late-breaking Science Program at the American Academy of Neurology's 61st Annual Meeting in Seattle, April 25 - May 2, 2009.
Researchers looked at four risk factors for stroke: high LDL cholesterol, low HDL cholesterol, high triglycerides, and high blood pressure. They found that for each risk factor that is controlled at the optimal level, the risk of stroke and other major cardiovascular problems goes down.
The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) study involved 4,731 people who had a recent stroke or transient ischemic attack, or mini stroke. Half received the cholesterol-lowering drug atorvastatin, and half received a placebo. The participants were followed for an average of 4.9 years.
People who reached optimal levels in all four risk factors were 65 percent less likely to have another stroke as people who did not reach optimal levels on any of the risk factors. Those who reached the optimal level on three risk factors were 38 percent less likely to have another stroke, and those who reached the optimal level on two risk factors were 22 percent less likely to have another stroke. Those who reached the optimal level on only one risk factor were only two percent less likely to have another stroke than people who did not meet any of the optimal levels.
"These results show that there is a cumulative effect to lowering cholesterol and blood pressure," said study author Pierre Amarenco, MD, of Denis Diderot University and Medical School in Paris, France, and a Fellow of the American Academy of Neurology. "People need to work with their doctors to reach the optimal level on all of these risk factors."
Amarenco said prior to this study researchers knew that lowering cholesterol and blood pressure was helpful overall in preventing stroke, but did not know whether one risk factor played a stronger role than another.
The optimal levels were defined as LDL "bad" cholesterol of lower than 70, HDL "good" cholesterol of higher than 50, triglycerides less than 150, and blood pressure less than 120/80.
The study was supported by Pfizer Inc.
Researchers looked at four risk factors for stroke: high LDL cholesterol, low HDL cholesterol, high triglycerides, and high blood pressure. They found that for each risk factor that is controlled at the optimal level, the risk of stroke and other major cardiovascular problems goes down.
The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) study involved 4,731 people who had a recent stroke or transient ischemic attack, or mini stroke. Half received the cholesterol-lowering drug atorvastatin, and half received a placebo. The participants were followed for an average of 4.9 years.
People who reached optimal levels in all four risk factors were 65 percent less likely to have another stroke as people who did not reach optimal levels on any of the risk factors. Those who reached the optimal level on three risk factors were 38 percent less likely to have another stroke, and those who reached the optimal level on two risk factors were 22 percent less likely to have another stroke. Those who reached the optimal level on only one risk factor were only two percent less likely to have another stroke than people who did not meet any of the optimal levels.
"These results show that there is a cumulative effect to lowering cholesterol and blood pressure," said study author Pierre Amarenco, MD, of Denis Diderot University and Medical School in Paris, France, and a Fellow of the American Academy of Neurology. "People need to work with their doctors to reach the optimal level on all of these risk factors."
Amarenco said prior to this study researchers knew that lowering cholesterol and blood pressure was helpful overall in preventing stroke, but did not know whether one risk factor played a stronger role than another.
The optimal levels were defined as LDL "bad" cholesterol of lower than 70, HDL "good" cholesterol of higher than 50, triglycerides less than 150, and blood pressure less than 120/80.
The study was supported by Pfizer Inc.
суббота, 6 августа 2011 г.
New Data Submitted To FDA Supporting Use Of Omacor With A Statin To Reduce High Triglycerides
Reliant Pharmaceuticals today announced a submission to the U.S. Food and Drug Administration (FDA) to seek approval for the expanded use of Omacor (omega-3-acid ethyl esters) as an adjunct to diet and statin therapy in adults whose triglyceride levels are high (200-499 mg/dL).? As part of this filing, Reliant submitted new data from the recently completed Combination of Omacor and Simvastatin (COMBOS) trial that evaluated the efficacy and safety of Omacor as an adjunct to diet and simvastatin therapy for the treatment of high triglycerides. ? COMBOS is a randomized, double-blind, placebo-controlled, parallel-group study including 254 patients.
"Currently, Omacor may help up to 5 million Americans whose triglyceride levels are very high," said Steven Ketchum, Ph.D., Senior Vice President, Research and Development, Reliant Pharmaceuticals.? "There are an estimated 27 million Americans who struggle to control high triglycerides.? By seeking this expanded indication, Omacor may serve as a safe, new treatment option for adults whose triglyceride levels remain high in spite of statin therapy."
Omacor is the first and only FDA-approved, prescription omega-3 fatty acid product, and has been proven safe and effective in clinical studies as an adjunct to diet to reduce very high triglycerides (?‰?500 mg/dL) in adult patients.? Very high triglycerides (?‰?500 mg/dL) impact 4-5 million people in the United States.? Omacor contains the key omega-3 components, eicosapentaenoic acid (465 mg) and docosahexaenoic acid (375 mg), to reduce very high triglycerides, and is naturally derived through a unique, patented process that consistently creates a highly concentrated and purified prescription medicine.
When Omacor was granted FDA approval in 2004, the FDA issued an approvable letter for the use of Omacor as an adjunct to diet and statin therapy to reduce high triglyceride levels (200-499 mg/dL) in adult patients.? Submission of this response is intended to demonstrate the safety and efficacy of the expanded use of Omacor before FDA approval is granted.
?
About High Triglycerides
Like the other types of cholesterol, triglycerides are fats (lipids) that, in balanced and moderate amounts, perform significant and important functions in the body. Triglycerides are derived from either fats ingested from food or other energy sources like carbohydrates in the body.? After a meal, the calories that are not used immediately by tissues are then converted into triglycerides and distributed among fat cells to be stored.? Hormones found in the body then regulate the release of triglycerides from fat tissue so they may be used for energy between meals. ? According to the American Heart Association (AHA), a normal level of triglycerides is below 150 mg/dL.? Like cholesterol, triglyceride levels can be detected by a blood test.? A high triglyceride level causes a condition known as hypertriglyceridemia, which is linked to the occurrence of heart disease in some people.
?
Important Omacor Safety Information
Omacor is used along with a low-fat and low-cholesterol diet to lower very high triglycerides (fats) in adults. Before taking Omacor, your healthcare provider should help you try to control your very high triglyceride levels by: losing weight if you are overweight, increasing physical exercise, lowering alcohol use, treating diseases such as diabetes and low thyroid hormone levels (hypothyroidism), and adjusting other medications that may raise triglyceride levels such as certain blood pressure medications and estrogens.
?
Omacor should be used with caution in people allergic to fish.? Treatment to reduce very high triglyceride levels may result in elevations in LDL-C and non-HDL-C in some individuals.? The effect of Omacor on cardiovascular morbidity and mortality in patients with very high triglyceride levels has not been determined.
?
Tell your healthcare provider about all your medical conditions, including if you have liver problems, are pregnant, are trying to become pregnant or are breast-feeding.? Tell your healthcare provider if you take blood thinners.? If you take both Omacor and a blood thinner, your healthcare provider should monitor your clinical response.
?
The most common side effects observed in Omacor clinical trials were belching, infection, flu symptoms, upset stomach, rash and change in your sense of taste.?
?
For more detailed information about Omacor, ask your healthcare provider or go to omacorrx.
?
About Reliant Pharmaceuticals
Reliant Pharmaceuticals is a pharmaceutical company with integrated sales, marketing and development expertise that markets a portfolio of branded cardiovascular pharmaceutical products.? Reliant focuses on marketing promotionally sensitive pharmaceutical products to the high prescribing primary care, cardiovascular and specialist physician markets in the United States.? Reliant also acquires rights to and develops product candidates in mid- to late-stage clinical development.? Reliant's sales force infrastructure is comprised of approximately 825 sales professionals nationwide.
?
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995.
? To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission.
"Currently, Omacor may help up to 5 million Americans whose triglyceride levels are very high," said Steven Ketchum, Ph.D., Senior Vice President, Research and Development, Reliant Pharmaceuticals.? "There are an estimated 27 million Americans who struggle to control high triglycerides.? By seeking this expanded indication, Omacor may serve as a safe, new treatment option for adults whose triglyceride levels remain high in spite of statin therapy."
Omacor is the first and only FDA-approved, prescription omega-3 fatty acid product, and has been proven safe and effective in clinical studies as an adjunct to diet to reduce very high triglycerides (?‰?500 mg/dL) in adult patients.? Very high triglycerides (?‰?500 mg/dL) impact 4-5 million people in the United States.? Omacor contains the key omega-3 components, eicosapentaenoic acid (465 mg) and docosahexaenoic acid (375 mg), to reduce very high triglycerides, and is naturally derived through a unique, patented process that consistently creates a highly concentrated and purified prescription medicine.
When Omacor was granted FDA approval in 2004, the FDA issued an approvable letter for the use of Omacor as an adjunct to diet and statin therapy to reduce high triglyceride levels (200-499 mg/dL) in adult patients.? Submission of this response is intended to demonstrate the safety and efficacy of the expanded use of Omacor before FDA approval is granted.
?
About High Triglycerides
Like the other types of cholesterol, triglycerides are fats (lipids) that, in balanced and moderate amounts, perform significant and important functions in the body. Triglycerides are derived from either fats ingested from food or other energy sources like carbohydrates in the body.? After a meal, the calories that are not used immediately by tissues are then converted into triglycerides and distributed among fat cells to be stored.? Hormones found in the body then regulate the release of triglycerides from fat tissue so they may be used for energy between meals. ? According to the American Heart Association (AHA), a normal level of triglycerides is below 150 mg/dL.? Like cholesterol, triglyceride levels can be detected by a blood test.? A high triglyceride level causes a condition known as hypertriglyceridemia, which is linked to the occurrence of heart disease in some people.
?
Important Omacor Safety Information
Omacor is used along with a low-fat and low-cholesterol diet to lower very high triglycerides (fats) in adults. Before taking Omacor, your healthcare provider should help you try to control your very high triglyceride levels by: losing weight if you are overweight, increasing physical exercise, lowering alcohol use, treating diseases such as diabetes and low thyroid hormone levels (hypothyroidism), and adjusting other medications that may raise triglyceride levels such as certain blood pressure medications and estrogens.
?
Omacor should be used with caution in people allergic to fish.? Treatment to reduce very high triglyceride levels may result in elevations in LDL-C and non-HDL-C in some individuals.? The effect of Omacor on cardiovascular morbidity and mortality in patients with very high triglyceride levels has not been determined.
?
Tell your healthcare provider about all your medical conditions, including if you have liver problems, are pregnant, are trying to become pregnant or are breast-feeding.? Tell your healthcare provider if you take blood thinners.? If you take both Omacor and a blood thinner, your healthcare provider should monitor your clinical response.
?
The most common side effects observed in Omacor clinical trials were belching, infection, flu symptoms, upset stomach, rash and change in your sense of taste.?
?
For more detailed information about Omacor, ask your healthcare provider or go to omacorrx.
?
About Reliant Pharmaceuticals
Reliant Pharmaceuticals is a pharmaceutical company with integrated sales, marketing and development expertise that markets a portfolio of branded cardiovascular pharmaceutical products.? Reliant focuses on marketing promotionally sensitive pharmaceutical products to the high prescribing primary care, cardiovascular and specialist physician markets in the United States.? Reliant also acquires rights to and develops product candidates in mid- to late-stage clinical development.? Reliant's sales force infrastructure is comprised of approximately 825 sales professionals nationwide.
?
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995.
? To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission.
среда, 3 августа 2011 г.
Livazo(R) (Pitavastatin), A Statin With Beneficial Effects On Lipid Fractions Associated With Heart Disease, Launches In Lebanon
Kowa Pharmaceutical Europe welcomes the first regional launch of its
statin, Livazo (pitavastatin) in Lebanon, where it will be marketed by
Beirut-based Algorithm, under an exclusive license.
Aimed at patients with primary hyperlipidemia and / or mixed
dyslipidemia,(1) Lebanon will be the first market for Livazo outside the Far
East and the USA. Algorithm will launch Livazo in the rest of the Middle East
and North Africa from 2012 onwards.
Livazo is a potent statin that combines effective control on
LDL-cholesterol (LDL-C) and triglycerides (TG), long-term incremental
HDL-cholesterol (HDL-C) increase and, due to its novel structure, is less
likely to have drug-drug interactions.(2) Its effectiveness has been
demonstrated in several Phase III clinical studies:
- Livazo safely and effectively reduced LDL-C and achieved European
Atherosclerosis Society (EAS) guideline targets in the majority of
patients with primary hyperlipidemia or mixed dyslipidemia, similar
to reductions seen with atorvastatin(3) and simvastatin(4)
- Livazo 2 mg and 4 mg demonstrated comparable efficacy to commonly
prescribed statins with 2 mg Livazo demonstrating statistically
significant superior efficacy compared with simvastatin 20 mg in
lowering LDL-C, non high-density lipoprotein cholesterol (non-HDL-C)
and total cholesterol (TC)(4)
- Livazo effectively reduced LDL-C in the elderly(5) and also improved
LDL-C and other parameters of lipid metabolism in patients at higher
cardiovascular risk(2)
- Livazo was superior to pravastatin in improving LDL-C in elderly
patients (65 years)(5)
- Livazo demonstrated a gradual and sustained increase in HDL-C over the
long-term, supported by data from a 52 week extension study(6)
"We welcome innovative treatments such as Livazo, which not only lowers
LDL-C effectively but also addresses HDL residual risk and so has the
potential to increase the proportion of patients achieving treatment
targets," said Professor Ibrahim Salti, Professor of Medicine and Head of the
Division of Endocrinology and Metabolism at the American University of Beirut
in Lebanon. "Pitavastatin has shown good efficacy in metabolic syndrome
patients without effect on HbA1C levels, as well as in elderly patients. The
low drug-drug interaction makes it an attractive option for clinically
complex patients on multiple medications."
High cholesterol levels are a major risk factor for heart disease, the
number one cause of death globally.(7) In Lebanon, about one sixth of all
adults has high blood cholesterol, but only two fifths of these receive
medical treatment for it.(8)
The overall safety and tolerability of pitavastatin are consistent with
other commonly prescribed statins. In Phase III studies comparing
pitavastatin with atorvastatin(3), simvastatin(4) and pravastatin(5), the
overall safety profile of pitavastatin was demonstrated, with low incidences
of adverse events. All three doses of pitavastatin (1, 2 and 4 mg)
demonstrated a comparable safety profile to 10, 20 and 40 mg of
pravastatin(5), which is considered to be the statin least likely to cause
adverse drug reactions or drug-drug interactions. Additionally, pitavastatin
has demonstrated a long-term safety profile (to 52 weeks),(6) comparable to
that of simvastatin or atorvastatin.(9,10)
Drummond Paris, President of Kowa Research Europe, said: "The launch of
Livazo in Lebanon represents a milestone for Kowa as our first product in
this region. It will be the first of many launches in Europe, the Middle East
and North Africa during 2011. We are keen to offer the benefits of Livazo to
patients across the globe."
References
1. Livazo Summary of Product Characteristics
2. Ose L. Pitavastatin: finding its place in therapy. Ther Adv Chronic
Dis. 2011. Published online before print. January 26, 2011, doi:
10.1177/2040622310389227
3. Budinski D, Arneson V, Hounslow N, Gratsiansky N. Pitavastatin
compared with atorvastatin in primary hypercholesterolemia or
combined dyslipidemia. Clin. Lipidol. 2009;4:291-302
4. Ose L, Budinski D, Hounslow N, Arneson V. Comparison of pitavastatin
with simvastatin in primary hypercholesterolaemia or combined
dyslipidaemia. Curr Med Res Opin 2009;25: 2755-64
5. Stender S, Hounslow N. Robust efficacy of pitavastatin and comparable
safety to pravastatin. Atherosclerosis Suppl. 2009; 10:e945
6. Ose L, Budinski D, Hounslow N, Arneson V: Long-term treatment with
pitavastatin is effective and well tolerated by patients with primary
hypercholesterolemia or combined dyslipidemia. Atherosclerosis 2010;
202-208
7. World Health Organization. Cardiovascular diseases fact sheet.
Accessed on 14 February, 2011.
See here.
8. Rady, A. Is lifestyle affecting the risk of non-communicable diseases
in Lebanon? Human & Health 2010;13:15-17
9. Data on file (study 309)
10. Data on file (study 310)
About Livazo
Pitavastatin (a statin) is a fully synthetic and highly potent inhibitor
of HMG-CoA reductase used for primary hypercholesterolemia and combined
dyslipidemia. Pitavastatin has a unique cyclopropyl group on the base
structure common to the statin class. Since its 2003 launch in Japan,
pitavastatin has accumulated millions of patient-years of exposure. Many of
these patients have co-morbidities and are taking multiple medications. Kowa
received FDA approval of pitavastatin (Livalo(R)) for the treatment of
primary hyperlipidemia or mixed dyslipidemia in August 2009 and it was
launched in the U.S. in June 2010. Additionally, Kowa filed in Europe in
August 2008 using the decentralised authorisation procedure and received
regulatory approval in mid 2010. In much of Europe, pitavastatin will be
marketed by Recordati. Pitavastatin will be available in three dosage
strengths (1 mg, 2 mg and 4 mg).
*1. Co-marketing by the two companies under one brand name, Livalo. The
annual sales of Livalo tablets in Japan reached $520 million in 2010.
*2 Kowa (Shanghai) Pharma Consulting Co. Ltd., a wholly-owned subsidiary
of Kowa, is obtaining and providing information to physicians and hospitals
in China to ensure proper use of pitavastatin.
*3 In the United States, Kowa Pharmaceuticals America, Inc. (Headquarters
in Alabama, US), a wholly-owned subsidiary of Kowa, sell and market
pitavastatin with a co-promotion partner, Eli Lilly (Headquarters in Indiana,
US).
*4 In Europe, pitavastatin will be distributed by Kowa Pharmaceutical
Europe Co. Ltd. (Headquarters in Wokingham, UK), a wholly-owned subsidiary of
Kowa, and Recordati (Headquarters in Milan, Italy), a partner distributor.
About Algorithm
Algorithm, pharmaceutical manufacturer based in Lebanon, aims
at being the trusted regional partner to medical and patient communities and
is committed to delivering quality care in pharmaceutical therapies. It
operates in the Middle East and North Africa region with a product portfolio
consisting of innovative products as well as differentiated generics,
focusing mainly on the following therapeutic areas: cardiology,
endocrinology, neurology, gynaecology and urology. Algorithm has built
partnerships with many international companies, amongst which is Kowa.
statin, Livazo (pitavastatin) in Lebanon, where it will be marketed by
Beirut-based Algorithm, under an exclusive license.
Aimed at patients with primary hyperlipidemia and / or mixed
dyslipidemia,(1) Lebanon will be the first market for Livazo outside the Far
East and the USA. Algorithm will launch Livazo in the rest of the Middle East
and North Africa from 2012 onwards.
Livazo is a potent statin that combines effective control on
LDL-cholesterol (LDL-C) and triglycerides (TG), long-term incremental
HDL-cholesterol (HDL-C) increase and, due to its novel structure, is less
likely to have drug-drug interactions.(2) Its effectiveness has been
demonstrated in several Phase III clinical studies:
- Livazo safely and effectively reduced LDL-C and achieved European
Atherosclerosis Society (EAS) guideline targets in the majority of
patients with primary hyperlipidemia or mixed dyslipidemia, similar
to reductions seen with atorvastatin(3) and simvastatin(4)
- Livazo 2 mg and 4 mg demonstrated comparable efficacy to commonly
prescribed statins with 2 mg Livazo demonstrating statistically
significant superior efficacy compared with simvastatin 20 mg in
lowering LDL-C, non high-density lipoprotein cholesterol (non-HDL-C)
and total cholesterol (TC)(4)
- Livazo effectively reduced LDL-C in the elderly(5) and also improved
LDL-C and other parameters of lipid metabolism in patients at higher
cardiovascular risk(2)
- Livazo was superior to pravastatin in improving LDL-C in elderly
patients (65 years)(5)
- Livazo demonstrated a gradual and sustained increase in HDL-C over the
long-term, supported by data from a 52 week extension study(6)
"We welcome innovative treatments such as Livazo, which not only lowers
LDL-C effectively but also addresses HDL residual risk and so has the
potential to increase the proportion of patients achieving treatment
targets," said Professor Ibrahim Salti, Professor of Medicine and Head of the
Division of Endocrinology and Metabolism at the American University of Beirut
in Lebanon. "Pitavastatin has shown good efficacy in metabolic syndrome
patients without effect on HbA1C levels, as well as in elderly patients. The
low drug-drug interaction makes it an attractive option for clinically
complex patients on multiple medications."
High cholesterol levels are a major risk factor for heart disease, the
number one cause of death globally.(7) In Lebanon, about one sixth of all
adults has high blood cholesterol, but only two fifths of these receive
medical treatment for it.(8)
The overall safety and tolerability of pitavastatin are consistent with
other commonly prescribed statins. In Phase III studies comparing
pitavastatin with atorvastatin(3), simvastatin(4) and pravastatin(5), the
overall safety profile of pitavastatin was demonstrated, with low incidences
of adverse events. All three doses of pitavastatin (1, 2 and 4 mg)
demonstrated a comparable safety profile to 10, 20 and 40 mg of
pravastatin(5), which is considered to be the statin least likely to cause
adverse drug reactions or drug-drug interactions. Additionally, pitavastatin
has demonstrated a long-term safety profile (to 52 weeks),(6) comparable to
that of simvastatin or atorvastatin.(9,10)
Drummond Paris, President of Kowa Research Europe, said: "The launch of
Livazo in Lebanon represents a milestone for Kowa as our first product in
this region. It will be the first of many launches in Europe, the Middle East
and North Africa during 2011. We are keen to offer the benefits of Livazo to
patients across the globe."
References
1. Livazo Summary of Product Characteristics
2. Ose L. Pitavastatin: finding its place in therapy. Ther Adv Chronic
Dis. 2011. Published online before print. January 26, 2011, doi:
10.1177/2040622310389227
3. Budinski D, Arneson V, Hounslow N, Gratsiansky N. Pitavastatin
compared with atorvastatin in primary hypercholesterolemia or
combined dyslipidemia. Clin. Lipidol. 2009;4:291-302
4. Ose L, Budinski D, Hounslow N, Arneson V. Comparison of pitavastatin
with simvastatin in primary hypercholesterolaemia or combined
dyslipidaemia. Curr Med Res Opin 2009;25: 2755-64
5. Stender S, Hounslow N. Robust efficacy of pitavastatin and comparable
safety to pravastatin. Atherosclerosis Suppl. 2009; 10:e945
6. Ose L, Budinski D, Hounslow N, Arneson V: Long-term treatment with
pitavastatin is effective and well tolerated by patients with primary
hypercholesterolemia or combined dyslipidemia. Atherosclerosis 2010;
202-208
7. World Health Organization. Cardiovascular diseases fact sheet.
Accessed on 14 February, 2011.
See here.
8. Rady, A. Is lifestyle affecting the risk of non-communicable diseases
in Lebanon? Human & Health 2010;13:15-17
9. Data on file (study 309)
10. Data on file (study 310)
About Livazo
Pitavastatin (a statin) is a fully synthetic and highly potent inhibitor
of HMG-CoA reductase used for primary hypercholesterolemia and combined
dyslipidemia. Pitavastatin has a unique cyclopropyl group on the base
structure common to the statin class. Since its 2003 launch in Japan,
pitavastatin has accumulated millions of patient-years of exposure. Many of
these patients have co-morbidities and are taking multiple medications. Kowa
received FDA approval of pitavastatin (Livalo(R)) for the treatment of
primary hyperlipidemia or mixed dyslipidemia in August 2009 and it was
launched in the U.S. in June 2010. Additionally, Kowa filed in Europe in
August 2008 using the decentralised authorisation procedure and received
regulatory approval in mid 2010. In much of Europe, pitavastatin will be
marketed by Recordati. Pitavastatin will be available in three dosage
strengths (1 mg, 2 mg and 4 mg).
*1. Co-marketing by the two companies under one brand name, Livalo. The
annual sales of Livalo tablets in Japan reached $520 million in 2010.
*2 Kowa (Shanghai) Pharma Consulting Co. Ltd., a wholly-owned subsidiary
of Kowa, is obtaining and providing information to physicians and hospitals
in China to ensure proper use of pitavastatin.
*3 In the United States, Kowa Pharmaceuticals America, Inc. (Headquarters
in Alabama, US), a wholly-owned subsidiary of Kowa, sell and market
pitavastatin with a co-promotion partner, Eli Lilly (Headquarters in Indiana,
US).
*4 In Europe, pitavastatin will be distributed by Kowa Pharmaceutical
Europe Co. Ltd. (Headquarters in Wokingham, UK), a wholly-owned subsidiary of
Kowa, and Recordati (Headquarters in Milan, Italy), a partner distributor.
About Algorithm
Algorithm, pharmaceutical manufacturer based in Lebanon, aims
at being the trusted regional partner to medical and patient communities and
is committed to delivering quality care in pharmaceutical therapies. It
operates in the Middle East and North Africa region with a product portfolio
consisting of innovative products as well as differentiated generics,
focusing mainly on the following therapeutic areas: cardiology,
endocrinology, neurology, gynaecology and urology. Algorithm has built
partnerships with many international companies, amongst which is Kowa.
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