Genetic Studies Offer Hint Of Clinical Benefits-And Risks- of PCSK9 Inhibitors

–Both cardiovascular benefits and increase in diabetes seem likely. There is no more eagerly awaited question in cardiovascular medicine than the clinical role of the PCSK9 inhibitors. The first reports from a series of outcomes trials are not due until next year. But two large genetic studies published this week deliver strong indirect evidence that…

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Saturated Fats Linked To Heart Disease Once Again

–But critics say that observational studies can’t establish causal relationship. A prominent group of nutrition researchers have once again linked saturated fats to increased coronary heart disease. The new paper, published in BMJ, is the third paper in the past year to decry saturated fats. Along with the previous two papers, published in JACC and JAMA Internal…

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Mixed Results For ApoA-1 Therapies

–It’s still not time to write the obituary for all HDL therapies. There was good news and bad news for a category of experimental drugs that attempt to mimic the putative beneficial effect of HDL at the American Heart Association meeting in New Orleans. Thirteen years after setting the field on fire with a promising…

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Pfizer Ends Development Of Its PCSK9 Inhibitor

–Immune issues and diminishing efficacy doomed the new drug. Pfizer announced on Tuesday that it was discontinuing development of bococizumab, its cholesterol-lowering PCSK9 inhibitor under development. “The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering agents, indicates that bococizumab is not likely to provide…

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Universal Child FH Screening Proposed

–Novel strategy would identify both children and adults at high risk for CV events. Doctors in the U.K. are proposing a novel strategy to identify very young children with familial hypercholesterolemia (FH). The strategy would also identify and help prevent events in the parents who also have FH. The new approach begins with a heel-stick…

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Novel Cholesterol Drugs Move Forward In Clinical Trials

–New information about upcoming cholesterol drugs from the Medicines Company and Esperion Recently the makers of two novel cholesterol-lowering drugs in development provided important updates on their progress. On Tuesday, the Medicines Company announced positive top-line results for a trial of its unusual PCSK9 synthesis inhibitor scheduled to be presented in November. Last week Esperion…

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LDL-Lowering Genetic Variants Linked to Diabetes Risk

–What can genetics tell us about diabetes incidence with cholesterol drugs? Editor’s note: The following guest post was contributed by Marilyn Mann, a well-known advocate for patients with familial hypercholesterolemia and a patient advisor to Circulation: Cardiovascular Quality and Outcomes. In a study published in the Journal of the American Medical Association, several LDL-lowering genetic…

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How Sweet: Sugar Industry Made Fat the Villain

–Harvard researchers received sugar industry money to write a NEJM review. Newly uncovered documents reveal that 50 years ago the sugar industry gave secret support to prominent Harvard researchers to write an influential series of articles in the New England Journal of Medicine that downplayed the negative effects of sugar. Instead, the articles shifted the blame…

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The Twitter Debate Over Cholesterol Screening In Kids

–Cardiologists discuss the screening controversy in 140 characters or less. My recent post on the debate over cholesterol screening in children provoked a fascinating discussion on Twitter, including comments from several highly knowledgeable experts and clinicians. The discussion started when James Stein, a preventive cardiologist at the University of Wisconsin), tweeted: Lipid screening in kids….

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Experts Disagree About Cholesterol Screening In Kids

(Updated) –Lack of evidence leads to major disagreement over guidelines. Once again the US Preventive Services Task Force (USPSTF) has performed an invaluable— and almost certainly thankless— service. In a series of papers published in JAMA and Annals of Internal Medicine the USPSTF states unequivocally that there is no good high quality evidence to evaluate…

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Repatha Approved for Single Monthly Injection

–New hands-free system replaces three sequential shots The FDA has approved a device that can deliver a single monthly injection of evolocumab (Repatha), the cholesterol-lowering PCSK9 inhibitor manufactured by Amgen. Repatha is currently administered by subcutaneous injection in a 140-mg dose every 2 weeks or as a 420 mg monthly dose. Until now, the monthly…

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FDA Places Roadblock On Approval Path Of Novel Cholesterol Drug

Could this be the end of LDL as a surrogate? A possible shift in policy at the FDA means that a much heralded novel new cholesterol drug won’t reach the US market until 2022 at the earliest. Esperion Therapeutics’ bempedoic acid (formerly known as ETC-1002) had previously been thought to be eligible for approval within…

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Study Questions ‘Lower Is Better’ For Cholesterol

–No added benefit for statin patients who reached very low LDL levels A large observational study suggests that moderate lowering of LDL may be just as effective as intensive lowering. “Our results do not provide support for a blanket principle that lower LDL cholesterol is better for all patients in secondary prevention,” the authors conclude….

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Cholesterol Skeptics Launch Another Attack

–But most experts say their study is highly flawed Once again, a group of cholesterol skeptics has published an inflammatory attack on the cholesterol hypothesis. But critics say that the paper is deeply flawed and should not be used to influence treatment or policy decisions. In a paper published in BMJ Open, Uffe Ravnskov, MD,…

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ASGR1 Gene Tied to Heart Health

(Updated) –May have stronger impact than PCSK9 variants on disease risk A large new study from Iceland has identified variants in a gene that appear to have powerful cardioprotective effects, perhaps an first early step toward a novel therapy for heart disease prevention and treatment. The gene, ASGR1, was identified by the well known genetic…

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Not So Rare, FH Is Truly Risky Lipid Disorder

–Not all elevated is LDL is equally dangerous CHICAGO — Familial hypercholesterolemia (FH), a condition that has long been overshadowed by more common cardiovascular diagnoses, has now found the spotlight in the big tent as a hot and even controversial topic. The new interest is driven by important advances in understanding the genetics of the…

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Recipe For Disaster: The New US Dietary Guidelines

The science of nutrition is a disaster. For a variety of very good reasons it is nearly impossible to perform high quality, long term randomized controlled trials to provide satisfactory answers to most of the pressing questions of the day. But many experts are convinced they do know the answer to many of these questions….

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Rat Study Links Neural Tube Defects To Lower PCSK9 Levels

(Updated) PCSK9 may play an important role in neural tube development (NTD), a new study in rats suggests. The study, published in Scientific Reports, found that PCSK9 levels were significantly reduced in rat embryos with NTDs. The main focus of the paper was to identify biomarkers that could be used for the prenatal detection of NTDs, since there are now…

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First Outcomes Trial Results For PCSK9 Drugs Will Come In 2016

In less than a year we may know a whole lot more about the PCSK9 inhibitors than we do now. Since the approval earlier this year of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Regeneron and Sanofi) critics and benefit managers have recommended strict limitations on use of the drugs because of the absence of evidence showing clinical benefit….

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FDA Panel Turns Down Expanded Indication For Ezetimibe

An FDA advisory panel on Monday voted 10-5 against an expanded indication for Merck’s ezetimibe (Vytorin, Zetia). The current label states that the drugs have not been shown to improve cardiovascular morbidity or mortality. The proposed expanded indication was based on findings from the IMPROVE-IT trial. The panel spent most of the day trying to interpret…

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Expect Intellectual Fireworks At FDA Advisory Panel On Ezetimibe

You can expect a lot of high-powered intellectual fireworks at next Monday’s FDA advisory panel considering Merck’s application to upgrade the indications for Vytorin and Zetia. Both brands contain the  cholesterol-lowering drug ezetimibe, which was studied exhaustively– in many senses of the word– in the IMPROVE-IT trial. The discussion will likely focus on what to do about missing data and how to…

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Merck Reveals That Its 30,000 Patient CETP Trial Will Continue

Despite rumors to the contrary the story of the CETP inhibitors isn’t quite over. Merck today announced that the REVEAL trial will continue. After a series of disappointing and often spectacular failures, REVEAL is the last remaining phase 3 trial of a CETP inhibitor still underway. REVEAL is a 30,000 patient trial studying Merck’s anacetrapib. In the announcement Merck said the…

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New Definition Of Familial Hypercholesterolemia Could Expand Patient Population For Expensive Cholesterol Drugs

More people may be diagnosed with familial hypercholesterolemia (FH) using criteria contained in a new scientific statement published by the American Heart Association. The expanded definition could also mean more patients will be eligible to receive expensive cholesterol-lowering drugs, including the new PCSK9 inhibitor drugs, (Repatha from Amgen and Praluent from Sanofi/Regeneron). But the biggest impact might be to increase the…

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More Questions About Nonprofit Groups And Industry Support

In response to my article about commercial funding of nonprofit organizations from the manufacturers of the PCSK9 inhibitors, Joshua Knowles wrote an eloquent and heartfelt defense of the FH Foundation, which receives some funding from industry. But I think he fails to address the fundamental underlying issues I wrote about in my piece. Knowles writes that “FH is a…

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Third Strike For CETP Inhibitors: Lilly Halts Big Evacetrapib Trial

For the third time a large trial testing a CETP inhibitor drug has gone down the tubes. On Monday morning Eli Lilly announced that it had terminated ACCELERATE, its large phase 3 trial of the drug evacetrapib. The company said the trial was stopped “due to insufficient efficacy” and that the company planned to discontinue…

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