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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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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‘Cardiology On A Collision Course With Specialty Pharmaceutical Pricing Models’

The recent approval of two new expensive cholesterol drugs “sets the practice of cardiology on a collision course with specialty pharmaceutical pricing models that were previously reserved for drugs that benefited relatively limited patient populations,” according to the authors of a perspective published in the New England Journal of Medicine. Until now cardiologists and other doctors treating the…

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New Cholesterol Drugs Gain Entry To Large Formulary

The two big and expensive new cholesterol drugs that everyone is talking about have both been added to the national preferred formulary of Express Scripts, the nation’s largest pharmacy benefit manager. The drugs– alirocumab (Praluent, from Regeneron and Sanofi) and evolocumab (Repatha, from Amgen)– are potent but expensive drugs that inhibit PCSK9 and dramatically lower LDL cholesterol. Both drugs…

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Report Concludes That PCSK9 Inhibitors Are Effective But Very Expensive

The new PCSK9 inhibitors– with an annual cost of over $14,000 a year– are far too expensive to be broadly used in eligible populations without restrictions, according to a draft report from the Institute for Clinical and Economic Review (ICER). The price of the new drugs would need to fall to nearly $2,000 in order for the drugs to…

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No Increase In Diabetes Found With Ezetimibe In IMPROVE-IT

A new analysis of the IMPROVE-IT trial found no significant increase in the rate of new onset diabetes in patients taking ezetimibe. Michael Blazing of Duke University presented the results of the IMPROVE-IT substudy on Tuesday afternoon at the European Society of Cardiology meeting in London. The analysis was prompted by previous findings from very…

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Novel Drug Could Cut LDL With Just 2 Or 4 Shots A Year

A novel drug still in phase 1 studies could dramatically lower cholesterol with only a few injections each year. Because the drug could be given during regular visits to the doctor it might help solve the thorny problem of drug compliance and adherence. Like the recently approved monoclonal antibodies alirocumab and evolocumab, the drug targets PCSK9 to lower LDL,…

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Cholesterol Wars: The Reimbursement Battle Begins

(Updated) The next stage of the cholesterol wars has officially started. With the recent approval of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Sanofi and Regeneron) the big immediate question everybody wanted answered was how the battle to pay for these expensive drugs (the wholesale acquisition cost is more than $14,000/year for both drugs) would shape…

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FDA Approves Repatha, Amgen’s PCSK9 Inhibitor

Late on Thursday Amgen announced that the FDA had approved its highly anticipated and much debated PCSK9 inhibitor, Repatha (evolocumab). The drug will be the second PCSK9 inhibitor on the market, following the approval last month of Sanofi’s and Regeneron’s  Praluent (alirocumab). In a press release the FDA said Repatha “is approved for use in addition to diet…

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More Preliminary Signs That PCSK9 Inhibitors May Improve Outcomes

More information about the highly anticipated new cholesterol lowering drugs from Amgen and Sanofi/Regeneron emerged today. A new new analysis of available data from early trials with PCSK9 inhibitors adds to the growing evidence showing that the drugs– Amgen’s evolocumab and Sanofi’s alirocumab– dramatically lower LDL cholesterol and offers additional preliminary evidence showing that they are safe and may confer a…

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Should You Be Worried About The Neurocognitive Side Effects Of The New Cholesterol Drugs?

The big news yesterday was important additional information about the new cholesterol lowering PCSK9 inhibitors from Amgen and Sanofi/Regeneron. As I reported then, the studies were broadly consistent, showing the powerful cholesterol-lowering effects of the drugs and providing an early suggestion that the drugs may lead to significant reductions in heart attacks, stroke, and other cardiovascular events. But one finding, though not…

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New Cholesterol Drugs: Highly Effective But Important Questions Remain

New information emerged today about two new cholesterol-lowering drugs that have been attracting a lot of attention. Data about the PCSK9 inhibitors– evolocumab, under development by Amgen, and alirocumab, under development by Sanofi and Regeneron– were published in the New England Journal of Medicine. The effects of the two drugs appeared to be broadly consistent. Both lowered LDL cholesterol powerfully,…

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No, The New Cholesterol Drugs From Sanofi And Amgen Aren’t Going To Cost $150 Billion A Year

In an article on the Health Affairs blog 4 CVS executives speculate that the new cholesterol lowering PCSK9 inhibitors from Amgen and Sanofi might achieve yearly sales of $150 billion or even higher. I think these numbers are a bit silly. But first let’s take a look at their extremely bullish case…. … Click here to read the full post on Forbes.  …

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New US Guidelines Will Lift Limits On Dietary Cholesterol

The influential  Dietary Guidelines Advisory Committee has recommended that limitations on dietary cholesterol be removed from the upcoming 2015 edition of Dietary Guidelines for Americans. Recommendations to reduce dietary cholesterol have been a mainstay of the USDA and other guidelines for many years, starting with guidelines from the American Heart Association in the 1960s. … Click here to read…

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Sanofi And Regeneron Leapfrog Amgen In New Cholesterol Drug Race

Early on Monday Sanofi and Regeneron leapfrogged their rival Amgen to gain leadership in the race to bring a new class of cholesterol drugs to market. The new development could potentially give Sanofi and Regeneron a month on the market by itself before facing competition from Amgen. Sanofi and Regeneron announced early on Monday that the FDA had accepted for priority review the Biologics…

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Success For 40-Year Effort In One Rural County To Curb Cardiovascular Disease

A 40-year program in one poor rural county to combat cardiovascular disease appears to have been successful, resulting in reduced rates of hospitalization and death compared with other counties in the same state over the same time period. The new findings from the study are described in a paper published in the Journal of the American Medical Association. ……

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HDL Raising Drugs Probably Won’t Work But This Might

A new study offers important new insights into the protective role of HDL cholesterol (the “good” cholesterol) against cardiovascular disease. Earlier studies with drugs that increase HDL levels, including niacin and CETP inhibitors, have not shown benefit. The new study suggests that simply increasing HDL levels isn’t the way to go. Instead, cholesterol efflux, the ability of HDL to…

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