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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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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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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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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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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ACCELERATE Puts the Brake on CETP Inhibition

–No benefit with evacetrapib despite increase in HDL and decrease in LDL The fat lady hasn’t sung, the referee hasn’t counted up to 10, but it’s sure not looking good for the once highly promising class of drugs known as the CETP inhibitors. Bang the Drum Slowly, and Play the Fife Lowly Following the crash…

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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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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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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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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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IMPROVE-IT Substudy: Ezetimibe Benefit Restricted To Diabetics

The beneficial effects of ezetimibe are found almost exclusively in  patients with diabetes, according to an update of the influential IMPROVE-IT trial presented on Sunday at the European Society of Cardiology meeting in London. The new finding may lead to questions about the widely accepted interpretation of the main finding of the trial, which is that it provided strong support for…

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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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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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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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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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IMPROVE-IT Trial Paper Won’t Be Published Right Away In The New England Journal Of Medicine

The presentation of the eagerly awaited IMPROVE-IT trial, scheduled for Monday at the American Heart Association meeting, won’t be accompanied by a simultaneous publication in the New England Journal of Medicine. Although no one except for a small group of insiders knows for sure, this news may have important implications. … Click here to read the full post on Forbes.  …

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Newly Identified Mutations Act Like a Lifetime of Treatment with Ezetimibe

A very large genetic study published in the New England Journal of Medicine offers compelling evidence in support of a central role for LDL cholesterol in coronary heart disease. In a series of studies analyzing blood samples from nearly 100,000 people, Sekar Kathiresan and colleagues identified 15 rare mutations that block the activity of a single gene — called Niemann-Pick…

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What You Need To Know About IMPROVE-IT

The IMPROVE-IT trial will be big news when its results are finally presented on November 17 during the annual meeting of the American Heart Association. The results of the trial–underway for nearly a decade– have been long and eagerly awaited by everyone interested in cardiovascular medicine.  The trial could impact the future sales of a key Merck drug, ezetimibe, though because it is nearing…

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Genetic Study Suggests Possible Causal Role for LDL in Aortic Valve Disease

Although LDL is an important risk factor for aortic valve disease, the precise role it plays has been uncertain. Lipid-lowering therapy in people with established aortic valve disease has not been shown to be beneficial. Now, however, a new genetic study published in JAMA suggests that LDL cholesterol may in fact cause an increase in aortic valve calcium…

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Cholesterol Drugs Haunted By Ghosts Of Past, Present, And Future

Cholesterol drugs, both new and old, are in the news again. There’s a lot going on now but the picture won’t really become clear until next month, when the results of a decade-old trial will finally be revealed. Briefly, here’s what’s happening: Two new trials presented fresh evidence that PCSK9s, the much discussed new class of…

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Early Hint At Cardiovascular Outcomes With Sanofi’s and Regeneron’s Rapidly Advancing Cholesterol Drug

Amid a slew of new data demonstrating yet again that PCSK9 inhibitors lower LDL cholesterol– drastically and in a wide variety of different patient populations– data from one trial offers the first suggestion that the drugs may in fact improve cardiovascular outcomes. But the analysis, the authors cautioned, is a post-hoc analysis of a trial neither…

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IMPROVE-IT Trial Scheduled For Presentation In November

Results of the eagerly-awaited and highly controversial IMPROVE-IT trial are finally going to be revealed. The American Heart Association has announced that the  trial will be presented by Chris Cannon on November 17 at 11:51 AM (central time) in Chicago at the group’s annual scientific sessions . IMPROVE-IT compared the effect on cardiovascular outcomes of the statin simvastatin with Vytorin (the combination of…

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New Evidence Fuels Concerns About The Safety Of Niacin

The string of failures– for HDL therapies in general and for niacin in particular– continues unabated.  The publication of the main results of the HPS2-THRIVE trial, along with new information from the AIM-HIGH trial, provide no evidence of a beneficial effect for niacin but do fuel concerns that it may cause serious adverse effects. ……

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