Phoenix Marketing Study Demonstrates Impact Of Press Coverage And Advertising On Cholesterol Drug Users And Medication Brands

March 29, 2008

A burst of unfavorable or confusing publicity often prompts users of prescription medications to take swift actions that can hurt those medications’ brand perception and market share, according to researchers at Phoenix Healthcare, a Phoenix Marketing International practice.

A recently released Phoenix study titled “Impact of Publicity on Consumer Perceptions and Actions in the Cholesterol Medication Category” also showed that doctors who treat such users are often hard pressed to respond with the latest information to a flurry of questions and requests for assistance. Such events create opportunities for competitors to convey positive reinforcement for their brands and take advantage of market turmoil.

Phoenix conducts a monthly brand audit that tracks consumers diagnosed with cholesterol problems; the audit records the consumers’ perceptions and documents their behaviors with regard to all brands of cholesterol medication. In January 2008, pharmaceutical firms experienced a critical need for such an audit to gauge consumer reaction to news about medications. The ENHANCE clinical trial for Vytorin and Zetia resulted in unfavorable press coverage, and Dr. Robert Jarvik came under fire as media reports questioned his qualifications to act as spokesman for Lipitor.

Perceptions and Attitudes Can Change Rapidly in Response to News Reports

In its most recent study, Phoenix evaluates and compares how the mix of publicity and public advertising helped some brands of cholesterol medication but not others. Phoenix researchers also determined that approximately four in ten patients who are on any type of cholesterol medication - not just those taking Zetia, Vytorin, or Lipitor - subsequently came to believe that medications for lowering cholesterol levels may not be as beneficial as they had once thought.

The news on the clinical trial was partially countered by a full page public service advertisement from Merck Schering Plough, the makers of Vytorin and Zetia. But consumer-stated intentions indicate that as long as negative publicity continues, the market share of some products will continue to erode. The overall market for cholesterol medications will likely experience shrinkage as well.

“The impact of negative publicity surrounding those two items - the ENHANCE clinical trial and Dr. Jarvik as a spokesperson - has broad implications for every brand of cholesterol medication,” stated Doug Zabor, executive vice president of Phoenix Healthcare.

“This new monthly Cholesterol Audit provides us with a great way to continuously monitor what’s happening in this category, allowing us to provide clients with fast feedback on changes to their brand and what’s driving those changes,” said Mike Rosenberg, Phoenix Healthcare president.

The syndicated Phoenix Cholesterol Advertising and Communication Audit draws from a large projectable sample of consumers every month and covers all advertisements in television, print, radio, and digital formats. Reports are available to subscribers monthly, quarterly, and semiannually. Phoenix will launch similar audits in Women’s Health, Sleep, and Chronic Pain in 2008.

About Phoenix Healthcare

Phoenix Healthcare Practice provides business solutions through research for the healthcare industry. We deliver value through the strategic application of marketing, relationships, and communications research. Phoenix Healthcare combines a high level of industry-based expertise with sophisticated research competencies and projective modeling by applying a “consultant” approach to business problem resolution.

Phoenix Healthcare

About Phoenix Marketing International

Founded in 1999, Phoenix Marketing International is one of the fastest growing marketing services firms in the United States and partner to many of the largest companies in the financial services, consumer package goods, automotive, healthcare, and travel and leisure industries worldwide. With offices across the United States, Phoenix also offers advanced advertising and brand measurement along with direct marketing expertise.

Phoenix Marketing International

Karo Bio Strengthens Eprotirome Phase II Program With Additional Clinical Study

March 29, 2008

Karo Bio initiates the second clinical phase IIb dose ranging study with eprotirome. This study will be conducted in dyslipidemia patients receiving concomitant treatment with the cholesterol absorption inhibitor ezetimibe.

The first phase IIb study in 180 patients where eprotirome is given in addition to statin treatment is progressing according to plan.

Karo Bio’s compound eprotirome is a novel, selective, thyroid hormone agonist for treatment of dyslipidemia. In a first phase IIa study, eprotirome induced a significant LDL-cholesterol lowering of 25-30% in dyslipidemia patients. Furthermore, eprotirome significantly reduced other risk factors for development of cardiovascular disease such as triglycerides and lipoprotein(a), and was well tolerated.

Eprotirome has a promising profile for treatment of dyslipidemia, either alone or in combination with other dyslipidemia drugs. Currently eprotirome is given in addition to simvastatin or atorvastatin in the first phase IIb dose ranging study in 180 patients. This study is progressing according to plan and the results will be available in the third quarter of 2008.

The intention with the new phase IIb dose ranging study is to expand the clinical and commercial potential for eprotirome in dyslipidemia treatment by exploring whether eprotirome in combination with ezetimibe can serve as an alternative to statin treatment. Ezetimibe is a well documented cholesterol absorption inhibitor and thus complements eprotirome well with a different mechanism of action. The study is a placebo controlled, parallel group, double blind, 10 week study dose ranging study in 100 patients. Eprotirome is given once daily in doses of 25, 50, or 100 μg in addition to 10 mg per day of ezetimibe. The results of the study are expected in the fourth quarter of 2008.

“Eprotirome has potential to become a major drug in the treatment of high blood lipids. The broad and unique efficacy profile affecting several independent risk factors for the development of cardiovascular disease, in combination with good tolerability and safety, makes eprotirome a very attractive therapeutic option, either as a single agent or in combination with statins or ezetimibe. With this phase II program we are positioning eprotirome for partnership negotiations and phase III clinical studies”, says Per Olof Wallstr?m, President of Karo Bio.

Facts about the market for dyslipidemia treatment Elevated blood lipids (dyslipidemia) significantly correlate with development of cardiovascular disease. In particular high plasma levels of the harmful LDL-cholesterol contribute to disease development. Statins are an effective class of drugs that is widely used for treatment of dyslipidemia. Still, there is a great need for new dyslipidemia drugs that can be used together with statins since a significant part of the patients do not reach the treatment goals on single therapy or are intolerant to or unresponsive to statin treatment. The trend is therefore to combine statin treatment with other pharmaceuticals in order to reach desirable effects Combinations with cholesterol absorption inhibitors, like ezetimibe, have been successful but there is still a great need for new treatment options.

The total dyslipidemia market has annual sales around USD 30 billion, whereof the statin class of drugs account for USD 25 billion.

About Karo Bio

Karo Bio is a drug discovery and development company specializing in nuclear receptors for the development of novel pharmaceuticals.

The Company has a strong project portfolio with innovative molecules that primarily targets metabolic diseases such as diabetes, atherosclerosis and dyslipidemia. In all of these areas there are significant market opportunities and a need for new pharmaceuticals with new mechanisms of action. Karo Bio intends to bring selected compounds within niche therapeutic areas into late stage clinical development and, potentially, to the market. In addition to pursuing niche opportunities, Karo Bio continues to develop compounds aimed at treatment of broad patient populations to clinical proof of concept before out-licensing.

In addition to the proprietary projects, Karo Bio has three strategic collaborations with international pharmaceutical companies for development of innovative therapies for the treatment of common diseases.

Karo Bio is listed on the OMX Nordic Exchange Stockholm AB since 1998 (Reuters: KARO.ST).

http://www.karobio.com/

VAP Test Helps Researchers Uncover Best Cholesterol Lowering Treatment For Type II Diabetes

March 26, 2008

The VAP cholesterol test from Atherotech is helping physicians pinpoint the most effective cholesterol and heart disease risk lowering treatments in Type II diabetes patients, providing valuable and potentially lifesaving information to diabetics and the doctors who treat them.

Leveraging the expanded cholesterol profiling capabilities of the VAP test, researchers in the Diabetes and Combined Lipid Therapy Regimen (DIACOR) study found that combining statin therapy with a fibrate is the most effective way to correct an adverse cardiovascular risk profile in individuals with diabetes and mixed dyslipidemia (elevated LDL cholesterol and triglyceride levels combined with decreased levels of HDL cholesterol).

The results of the 12-week, single center, double-blind, placebo-controlled study were recently published in American Journal of Cardiology. Researchers were able to use the VAP Test to measure the effects of simvastatin alone, fenofibrate alone and the combination of both on lipid subparticles in 300 patients (randomized) with Type II diabetes without existing heart disease.

“Among diabetic patients with multiple lipid abnormalities, the combination therapy of a statin and a fibrate, not only was superior to either agent alone in improving the standard lipid markers of LDL (the bad cholesterol), HDL (the good cholesterol) and triglycerides, it was also superior in reducing a variety of the more atherogenic lipid profiles detectable through the use of the VAP assay,” explained study coauthor Joseph B. Muhlestein, M.D. “Most importantly, it significantly lowered the overall density of a variety of atherogenic lipid particles and also reduced the levels of Lp(a), an especially hard to treat marker of cardiovascular risk. This information increases the likelihood that combination lipid therapy in this high risk population may provide significant long-term clinical benefit.”

The VAP Test provides researchers and medical professionals with direct measurement of LDL, HDL and all relevant subclasses, emerging risk factors (such as Lp(a), LDL pattern, density and size) and precise calculations for LDL components.

“As we continue to learn more about cardiovascular risk associated with various lipid subfraction profiles, the value of the VAP assay is likely to become even more clinically relevant,” noted Muhlestein.

Atherotech Chief Medical Officer James Ehrlich, M.D., said VAP technology has been used in more than 100 clinical trails and will continue to play an important role as a valuable analytical research tool.

“This type of research has never before been conducted for the diabetic population, and we’re proud of the important role that the VAP test has played in this and other studies,” said Ehrlich. “The identification of additional risk factors through the advanced lipid testing of the VAP Test gives physicians and clinicians the information they need to more accurately assess, manage and lower heart disease risk in Type II diabetes patients.”

About Atherotech, Inc.

Atherotech is a cardio-diagnostic company focusing on direct measurement of the comprehensive lipid panel using the company’s patented VAP Technology. The VAP Test directly measures the cholesterol content of all lipids, components and subclasses. It is the first cholesterol profile to comply with updated National Cholesterol Education Program ATP III recommendations calling for more accurate, direct low-density lipoprotein (LDL) measurement, which is unaffected by triglycerides. The VAP Cholesterol Test — the new standard of care for patients at risk for cardiovascular disease — is available through national and regional diagnostic laboratories and is reimbursed by most payers as well as Medicare. For more information, visit http://www.thevaptest.com.

Atherotech, Inc.
http://www.atherotech.com

Cholesterol-Associated Gene Variants Can Predict Cardiovascular Events

March 21, 2008

A study appearing in this week’s New England Journal of Medicine confirms that a combination of gene variants previously associated with cholesterol levels does reflect patients’ cholesterol levels and can signify increased risk of heart attack, stroke or sudden cardiac death. Led by researchers from the Massachusetts General Hospital Cardiology Division, the study’s findings are a first step towards the ability to identify individuals who might benefit from earlier use of cholesterol-lowering medications and other measures to combat elevated risk.

“The prospect of personalized medicine has received much hype, but until recently, there has been little hard evidence to support the promise,” says Sekar Kathiresan, MD, MGH Director of Preventive Cardiology, the paper’s lead author. “We feel that our data provides two insights. First, we provide a foundation for the possibility that a panel of gene variants will eventually be useful in preventive cardiac care. Second, we show that the combination of multiple variants related to cholesterol importantly contribute to the genetic risk for heart attack.”

It is estimated that about half the variation in high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol levels is inherited, rather than being caused by lifestyle factors such as diet and exercise. While studies have associated several gene variants with cholesterol levels, exactly how those variants impact the risk of cardiovascular disease is unclear. The current study was designed to explore the influence of those variants on the risk of cardiovascular events — heart attack, stroke or sudden cardiac death — and whether measuring such variants could help predict risk better than simply measuring HDL and LDL levels.

Since the effects of individual gene variants appears slight, the research team looked at a combination of 9 single-nucleotide polymorphisms (SNPs) previously associated with cholesterol levels. They analyzed data from 5,414 Swedish adults who participated in a major prospective epidemiological study and correlated data — including standard measurements of HDL and LDL cholesterol and the presence of the 9 gene variants — with information on the participants’ subsequent medical histories available from a registry of information collected on all Swedish citizens. After the initial genotyping of participants not receiving lipid-lowering therapy, participants were assigned a genotype score ranging from 0 to 18, based on how many copies of the unfavorable SNPs they carried. Of the participants who had no cardiovascular events before enrolling in the study, 238 suffered a heart attack, stroke or cardiac death during the subsequent 10.6 years.

Higher genotype scores did reflect higher LDL (”bad”) cholesterol and lower HDL (”good”) cholesterol levels. Importantly, those with genotype scores of 11 or higher had a 63 percent greater risk of a cardiovascular event than did those with scores of 9 or lower. Although testing for the panel of 9 SNPs was not better than standard risk factors for predicting cardiac events in the overall population, among participants classified at intermediate risk by standard measures, adding the 9-SNP panel significantly improved the ability to distinguish truly elevated or reduced risk levels.

“A current clinical dilemma is how early to start patients on cholesterol-lowering medications like statins that can reduce the risk of heart attack. Our data suggest that those individuals classified as higher risk based on a genetic test may deserve more intense pharmacological and lifestyle treatments,” says Kathiresan. “But before we can move from our pilot data to information that can impact the care of patients with or at risk for cardiovascular disease, we need to discover all the risk-related variants — and there will probably be 50 to 100 — and then conduct clinical studies confirming that this information can reliably guide patient care.” Earlier this year Kathiresan, an instructor in Medicine at Harvard Medical School, and colleagues from the Broad Institute of Massachusetts Institute of Technology and Harvard University began this gene-discovery process and identified six new cholesterol-associated gene variants in a separate study published in Nature Genetics.

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Support for the NEJM study includes grants from the Doris Duke Charitable Foundation, the Fannie Rippel Foundation, the Donovan Family Foundation and the National Institutes of Health. Study co-authors are David Altshuler, MD, PhD, and Christopher Newton-Cheh, MD, MPH, MGH; Olle Melander, MD, PhD, Dragi Anevski, PhD, Charlotta Roos, MSc, Goran Berglund, MD, PhD, Bo Hedblad, MD, PhD, Leif Groop, MD, PhD, and Marju Orho-Melander, PhD, Lund University, Sweden; Candace Guiducci and Noel Burtt, Broad Institute; and Joel Hirschhorn, MD, PhD, Children’s Hospital Boston.

Massachusetts General Hospital (http://www.massgeneral.org/), established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $500 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine.

Source: Sue McGreevey
Massachusetts General Hospital

Study Links Protein To Risk Of Heart Disease

March 18, 2008

A new study published in the Journal of the American MedicalAssociation reports that there is an association between thegene for the HDL-associated protein paraoxonase 1 (PON1) and adversecardiac events such as coronary artery disease.Researcher Stanley L. Hazen, M.D., Ph.D (Cleveland Clinic) andcolleagues also find that variations in both the PON1 gene and itsenzyme activity may increase the likelihood of cardiovascular diseaseevents.

It has been believed that in animals, the PON1 gene preventsatherosclerosis (multiple plaques that harden the arteries). However,researchers have not found a similar cardio-protective role inhumans. Current literature does suggest, though, that it ispossible for PON1 to have antioxidant and cardio-protective properties.

Dr. Hazen and colleagues decided to investigate PON1 activity -anti-inflammatory and antioxidant activities - and a PON1 polymorphism(gene variation) Q192R in order to see if there is an association withhigher rates of cardiovascular disease, heart attack,stroke or death. They studied 1,399 patients who elected to undergodiagnostic coronary angiography from September 2002 to November 2003.Participants were followed-up until the end of 2007.

Hazen and colleagues found that participants in the highest PON1activity quartile (7.3% for paraoxonase) were significantly less likelyto have major adverse cardiac events compared to those in the lowestactivity quartile (25.1% for paraoxonase).

A second result of the study found that there were significantdose-dependent associations for PON1 polymorphisms, with decreasedlevels of serum PON1 activity and increased levels of oxidative stress(damage to cells and tissues when the levels of free radicals andantioxidants are not balanced.) Over the 3-year period after studyenrollment, the authors found an association between ailments such ascoronary artery disease and other adverse cardiovascular events and thePON1 Q192R polymorphism and serum PON1 activity.

The researchers conclude: “The current findings provide directprospective evidence of an important mechanistic link between the PON1gene and PON1 systemic activity measures with both multiplequantitative indices of oxidative stress and atherosclerotic heartdisease development in humans. Paraoxonase 1 is [strongly] associatedwith HDL particles within the circulation and has been argued topromote some of the anti-inflammatory and antioxidant effectsattributed to HDL. Thus, the present studies also provide furthersupport for the concept that functional properties beyond the abilityof HDL and its associated proteins to promote reverse cholesteroltransport contribute to the overall ability of this lipoprotein toreduce or prevent development of atherosclerosis.”

Stanley L. Hazen, et al.
JAMA (2008). 299[11]:1265-1276.
ClickHere to View Journal Website

Written by: Peter M Crosta
Copyright: Medical News Today

The Genes That Protect Against Atherosclerosis, A Major Cause Of Myocardial Infarction And Stroke

March 17, 2008

Myocardial infarction and stroke cause nearly half of all deaths in the Western World, and atherosclerosis is the main cause of myocardial infarction and stroke. Scientists from the Karolinska Institutet, Sweden, have shown with mouse models that the accumulation of the plaque that causes myocardial infarction and stroke can be avoided.

You can read about this in the March 14th issue of PLoS Genetic.

The authors write about prevention through reducing levels of bad LDL cholesterol before atherosclerotic plaque has progressed beyond a particular point. A network of 37 genes that reduce levels of blood cholesterol to bring about the beneficial effect has also been identified.

Team leader Johan Bj?rkegren, explained “Previously, much atherosclerosis research was focused on identifying ways to stabilise the most dangerous plaques in order to prevent them rupturing and causing myocardial infarction or stroke. Our discovery means that we can now target the actual development of dangerous plaques. The time when individual genes or gene pathways were thought to explain the development of complex common diseases, such as atherosclerosis, is past. We now have enough tools and knowledge of systems biology to take on the total complexity of these diseases.”

The findings indicate that atherosclerosis development does not follow a linear progression, but rather first develops slowly without severe inflammation, then speeds up, and within 10 weeks forms advanced plaques. Bringing down plasma cholesterol just before the rapid expansion can prevent the formation of advanced plaques, says Bj?rkegren. The authors took this information and determined 37 of the atherosclerosis genes that respond to the lowering of plasma LDL and prevent the formation of advanced plaques.

The study offers a comprehensive compendium of gene expression profiles of atherosclerosis development from healthy arteries to arteries with advanced plaques. Bj?rkegren admits there must be more than 37 genes in this network, and thus future studies can focus on adding to this group. Bj?rkegren adds that researchers also need to take these identified genes and use model systems in relevant cell cultures and animal model systems to determine their exact biological roles on atherogenesis.

“Transcriptional Profiling Uncovers a Network of Cholesterol-Responsive Atherosclerosis Target Genes”
Skogsberg J, Lundstro¨m J, Kovacs A, Nilsson R, Noori P, et al. (2008)
PLoS Genet 4(3): e1000036. doi:10.1371/journal.pgen.1000036
Link to article online

PLoS Genetics
http://www.plosgenetics.org

The Public Library of Science
http://www.plos.org

Written by - Christian Nordqvist
Copyright: Medical News Today

Genes That Protect Against Atherosclerosis Identified

March 14, 2008

One way of combating atherosclerosis is to reduce levels of “bad cholesterol” in the blood. Scientists at the Swedish medical university Karolinska Institutet have now identified the genes that bring about this beneficial effect.

In a new study on mice, which is presented in the open-access journal PLoS Genetics, the research group has shown that the accumulation of the plaque that causes myocardial infarction and stroke can be prevented if levels of the “bad” LDL cholesterol are reduced before atherosclerotic plaque has progressed beyond a particular point. The group has also identified a network of 37 genes that lowers levels of blood cholesterol and brings about the beneficial effect.

“Previously, much atherosclerosis research was focused on identifying ways to stabilise the most dangerous plaques in order to prevent them rupturing and causing myocardial infarction or stroke,” says Associate Professor Johan Bj?rkegren, who has led the study. “Our discovery means that we can now target the actual development of dangerous plaques.”

Rather than covering individual vessel wall genes, their discovery encompasses a network of genes, and one that explains their mutual interaction. It is on account of years of network algorithm development under Jesper Tegnér, professor of computational biology, that the discovery of gene networks has been made possible.

“The time when individual genes or gene pathways were thought to explain the development of complex common diseases, such as atherosclerosis, is past,” says Dr Bj?rkegren. “We now have enough tools and knowledge of system biology to take on the total complexity of these diseases.”

Atherosclerosis is the main cause of myocardial infarction and stroke, which cause almost half of all deaths in Sweden and other countries in the West.

‘Transcriptional Profiling Uncovers a Network of Cholesterol-Responsive Atherosclerosis Target Genes’
Josefin Skogsberg, Jesper Lundstr?m, Alexander Kovacs, Roland Nilsson, Peri Noori, Shohreh Maleki, Marina K?hler, Anders Hamsten, Jesper Tegnér, Johan Bj?rkegren
PLoS Genetics, 14 March 2008.
Please click here to view article online

Karolinska Institutet is one of the leading medical universities in Europe. Through research, education and information, Karolinska Institutet contributes to improving human health. Each year, the Nobel Assembly at Karolinska Institutet awards the Nobel Prize in Physiology or Medicine.

Karolinska Institutet

New Healthcare Marketing Vehicle Launches To Help Americans Living With Cholesterol, Diabetes And Obesity

March 13, 2008

HealthScreenDirect, a corporate wellness and direct-to-consumer health screening services company, announced today the launch of HealthPaks. This innovative cooperative advertising and marketing vehicle will feature exclusive health related products and services targeted to Americans living with high cholesterol, diabetes and obesity.

Currently, there are more than 100 million Americans with high cholesterol, almost 75 million living with diabetes and pre-diabetes, and nearly 134 million who are either overweight or obese. HealthPaks now provide a targeted, direct-to-consumer marketing opportunity for companies’ products and services that help consumers manage these medical conditions and live a healthier lifestyle.

Founded by Jason Buchwald, M.D., a board certified emergency room physician in Miami, Florida, HealthPaks were developed to address the growing epidemic of Americans living with high cholesterol, diabetes and obesity.

“The statistics are staggering as more and more people are living with these diseases than ever before,” said Dr. Jason Buchwald, CEO, HealthScreenDirect, LLC. “Cholesterol is a major contributor to heart disease, the leading cause of death in the United States. More than 1 million Americans are diagnosed each year with diabetes and nearly one-third of people are unaware they even have the disease. In addition, two-thirds of the adult population is overweight and one-third of them are obese.”

HealthPaks will be distributed to self-identified consumers living with the three disease states. Each HealthPak will feature no more than 10 category exclusive advertisements per mailing, which will guarantee high-visibility. Categories range from pharmaceutical companies and retail pharmacies to consumer good manufacturers and medical associations, among others.

HealthPak advertisers will also benefit from affordable pricing through a cooperative arrangement and positioning with other top healthcare and consumer brands in a national program. For a rate card or additional information on becoming an advertiser in HealthPaks, visit healthpak.healthscreendirect.org or call 1-800-940-7645.

“With so many people affected by cholesterol, diabetes and obesity, HealthPaks will also serve to provide consumers with valuable educational information and healthy living guidelines,” said Dr. Buchwald.

Following the launch of the Cholesterol, Diabetes and Obesity HealthPaks, the program will expand to include several other medical conditions such as arthritis, back pain and hypertension. HealthPaks will also soon be available online and via email.

About HealthPak

HealthPak is an innovative cooperative advertising and marketing vehicle featuring health related products and services targeting Americans living with high cholesterol, diabetes and obesity. Founded by Jason Buchwald, MD, a board certified physician in Miami, Florida, HealthPaks were developed to address the growing number of people living with these disease states. For more information about HealthPak, please visit http://www.healthpak.healthscreendirect.org.

About HealthScreenDirect

HealthScreenDirect, LLC, is a corporate wellness and direct-to-consumer health screening services company that focuses on delivering affordable, convenient and confidential testing for diabetes, cholesterol, hypertension and obesity.

http://www.healthscreendirect.org

Low-Fat Diets More Likely To Reduce Risk Of Heart Disease Than Low-Carb Diets

March 4, 2008

Low-fat diets are more effective in preserving and promoting a healthy cardiovascular system than low-carbohydrate, Atkins’-like diets, according to a new study by researchers at the Medical College of Wisconsin in Milwaukee.

The study, published in the February edition of the scientific journal Hypertension, was led by David D. Gutterman, M.D., Northwestern Mutual Professor of Cardiology, professor of medicine and physiology, and senior associate dean of research at the Medical College. Shane Phillips, M.D., a former Cardiology faculty member at the Medical College, and now assistant professor in the department of physical therapy at the University of Illinois - Chicago, was the lead author.

Public awareness of the “obesity epidemic” has resulted in various dietary weight loss strategies. In America, it is estimated that 45 percent of women and 30 percent of men diet to lose weight.

“The nutrient-specific effects of these diets on cardiovascular health are largely unknown,” says Dr. Gutterman.

“Low-carbohydrate diets are significantly higher in total grams of fat, protein, dietary cholesterol and saturated fats than are low-fat diets. While a low-carbohydrate diet may result in weight loss and improvement in blood pressure, similar to a low-fat diet, the higher fat content is ultimately more detrimental to heart health than is the low-fat diet suggested by the American Heart Association,” points out Dr. Phillips.

“The higher fat content of a low-carbohydrate diet may put dieters at an increased risk of atherosclerosis (hardening of the arteries) because low-carbohydrate diets often reduce protection of the endothelium, the thin layer of cells that line the blood vessels of the circulatory system. The reduced production from the endothelium of nitric oxide, a specific chemical, puts the vessel at higher risk of abnormal thickening, greater clotting potential, and cholesterol deposition, all part of the atherosclerosis process,” says Dr. Gutterman.

Over a six-week period, the researchers found reduced flow-mediated dilation in the arm artery in participants who were on the low-carbohydrate diet. Reduced flow-mediated dilation, as measured in this study, is an early indicator of cardiovascular disease. On the other hand, flow-mediated dilation improved significantly in participants on the low-fat diet suggesting a healthier artery which is less prone to developing atherosclerosis.

“We observed a reduction in brachial artery flow-mediated dilation after six weeks of weight loss on a low-carbohydrate, Atkins’-style diet,” Dr. Gutterman says.

Low-carbohydrate diets were also found to have significantly less daily folic acid than low-fat diets. Folic acid is thought to be helpful in reducing the likeliness of heart disease. This protective effect results from the antioxidant property of folic acid and its ability to lower levels of homocysteine, a naturally occurring amino acid that can be dangerous at elevated levels.

The low-carbohydrate diet provided 20 grams of carbohydrates daily and was supplemented with protein and fat content according to the Atkins’ diet recommendations. The low-fat diet provided 30 percent of the calories as fat, and was modeled after the American Heart Association’s recommendations.

“The composition of diet may be as important as the degree of weight loss in determining the effect of dietary interventions on vascular health,” Dr. Gutterman notes.

Twenty participants between the ages of 18 to 50 with a body mass index ranging from 29 to 39 were monitored for the study, and the type of diet was randomly assigned to participants. Weight loss, flow-mediated dilation, blood pressure and insulin and glucose levels in the participants were measured every two weeks for the six-week study.

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The study was funded by the support of the National Institutes of Health General Clinical Research Center and the Medical College of Wisconsin Cardiovascular Center. It was conducted at Froedtert Hospital, the College’s major teaching affiliate.

Co-authors of the study included Jason Jurva, M.D., assistant professor of medicine; Amjad Syed, resident in surgery (University of Illinois - Chicago); Amina Syed, resident in family practice with the Medical College of Wisconsin Affiliated Hospitals; Jacquelyn Kulinski, senior medical student; Joan Pleuss, senior research dietician; and Raymond Hoffmann, Ph.D., professor of population health in the division of biostatistics.

Source: Toranj Marphetia
Medical College of Wisconsin

Pfizer Announces Plans To End Lipitor Advertising Campaign With Artificial Heart Inventor Jarvik

February 28, 2008

Pfizer on Monday announced plans to end an advertising campaign for the cholesterol medication Lipitor that features Robert Jarvik, who invented the first artificial heart, amid concerns that the ads might mislead consumers, the New York Times reports. According to the Times, the case “has rekindled a debate over the so-called direct-to-consumer advertising of pharmaceuticals, a $4.8 billion business” (Saul, New York Times, 2/25).

In January, House Energy and Commerce Committee Chair John Dingell (D-Mich.) and Rep. Bart Stupak (D-Mich.), chair of the Oversight and Investigations Subcommittee, asked Pfizer to provide records on the ad campaign and Jarvik as part of a larger investigation into the use of celebrity endorsements in DTC ads for medications (Perrone, AP/Philadelphia Inquirer, 2/26). In a letter to Pfizer CEO Jeffrey Kindler, Dingell wrote that consumers might misinterpret the ad campaign, which began in 2007, because Jarvik is a “celebrity” and he “may not be a practicing physician with a valid license in any state” (Johnson, Wall Street Journal, 2/26).

Jarvik has a medical degree but is not licensed to practice medicine (AP/USA Today, 2/26). On his Web site, Jarvik describes himself as a medical scientist who has worked with artificial hearts for 36 years (Reuters/Los Angeles Times, 2/26).

Pfizer plans to introduce a new ad campaign for Lipitor in several weeks (Wall Street Journal, 2/26).

Comments
Ian Read, president of worldwide pharmaceutical operations at Pfizer, in a statement said, “The way in which we presented Dr. Jarvik in these ads has, unfortunately, led to misimpressions and distractions from our primary goal of encouraging patient and physician dialogue on the leading cause of death in the world — cardiovascular disease,” adding, “Going forward, we commit to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople” (New York Times, 2/25).

Dingell on Monday said that the decision by Pfizer to end the ad campaign was a “wise one” and that he “trusts Pfizer is sincere in its commitment to ‘greater clarity’ in its advertising” (Cohen, Newark Star-Ledger, 2/26). Stupak in a statement said, “I commend Pfizer for doing the right thing and pulling the Lipitor ads featuring Dr. Jarvik,” adding, “When consumers see and hear a doctor endorsing medication, they expect the doctor is a credible individual with requisite knowledge of the drug” (New York Times, 2/25).

Jarvik in a statement said, “I accepted the role of spokesman for Lipitor because I am dedicated to the battle against heart disease,” adding, “I am not a celebrity. I am a medical scientist specializing in advanced technology to treat heart failure” (Pettypiece, Bloomberg/Washington Post, 2/26).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2007 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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