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

ALN-PCS

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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After Long Wait, Updated US Cardiovascular Guidelines Now Emphasize Risk Instead Of Targets

Original illustration by Max Husten

Updated cardiovascular health guidelines were released today by  the American Heart Association (AHA) and the American College of Cardiology (ACC). The guidelines are designed to provide primary care physicians with evidence-based expert guidance on cholesterol, obesity, risk assessment, and healthy lifestyle. The new guidelines reinforce many of the same messages from previous guidelines, but also…

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WSJ Article Fails To Raise Key Questions About Cardiovascular Risk In Children

There’s probably no greater public health issue than the long-term  consequences of the childhood obesity epidemic. So the Wall Street Journal should be commended for digging into some of the important science behind this problem in a feature article in today’s paper. The author, Ron Winslow, is widely regarded as the best working journalist who…

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HPS2-THRIVE: A ‘Disappointing But Clear’ Result

The results of HPS2-THRIVE were “disappointing but clear,”  said Jane Armitage, who presented the results this morning at the ACC in San Francisco. HPS2-THRIVE randomized 25,673 high-risk patients who could tolerate niacin to either placebo or extended-release niacin plus laropiprant (Tredaptive, Merck), an anti-flushing agent, in addition to background therapy. The primary endpoint was the time to…

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Amid Rising Tide Of Diabetes More Patients Reach Treatment Goals

There’s a glimmer of good news amidst all the recent bad news about diabetes. Although the prevalence of diabetes has doubled over the last generation, more people today  are reaching their treatment goals than in the past. New data from the National Health and Nutrition Examination Surveys (NHANES), published online today in Diabetes Care, show that…

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Should Niacin Still Be Prescribed? William Boden Versus Harlan Krumholz

Harlan Krumholz

In the wake of HPS2-THRIVE many have argued that there is no longer any reason to prescribe niacin. William Boden, the lead investigator of AIM-HIGH and COURAGE, thinks there were enough flaws in the design of the niacin trials to justify the cautious use of niacin in certain circumstances. Says Boden: “There is evidence of…

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Large Metaanalysis Finds Statins Effective in Low Risk Patients

A very large metaanalysis provides strong evidence that the relative reduction in risk of statins is at least as great in low-risk patients as in high-risk patients. The finding, write the authors, provides evidence that expansion of guidelines to lower risk populations should be considered. In their paper in the Lancet, the  the Cholesterol Treatment Trialists’ (CTT)…

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