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…
Should You Be Worried About The Neurocognitive Side Effects Of The New Cholesterol Drugs?
March 16, 2015 by Leave a Comment
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…
New Cholesterol Drugs: Highly Effective But Important Questions Remain
March 15, 2015 by Leave a Comment
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,…
No, The New Cholesterol Drugs From Sanofi And Amgen Aren’t Going To Cost $150 Billion A Year
February 18, 2015 by Leave a Comment
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. …
New US Guidelines Will Lift Limits On Dietary Cholesterol
February 10, 2015 by Leave a Comment
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…
Sanofi And Regeneron Leapfrog Amgen In New Cholesterol Drug Race
January 26, 2015 by Leave a Comment
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…
Success For 40-Year Effort In One Rural County To Curb Cardiovascular Disease
January 13, 2015 by Leave a Comment
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. ……
HDL Raising Drugs Probably Won’t Work But This Might
November 18, 2014 by 1 Comment
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…
IMPROVE-IT Meets Endpoint And Demonstrates Real But Modest Clinical Benefit For Ezetimibe
November 17, 2014 by Leave a Comment
After all the waiting and all the controversy it turned out to be pretty simple. The IMPROVE-IT trial did what it set out to do and reached its primary endpoint. The benefit wasn’t very big or impressive but it will be enough to put to rest concerns that ezetimibe might have been an expensive placebo…
At the American Heart Association Meeting You Really Can’t Escape The New Cholesterol Drugs
November 15, 2014 by 1 Comment
There’s no escaping them. At the American Heart Association in Chicago going on right now Amgen and Sanofi/Regeneron, which are developing competing cholesterol lowering drugs known as PCSK9 inhibitors, have mounted a full scale attack to capture the eyeballs and the brains of cardiologists and any other innocent bystanders who happen to be at the…
IMPROVE-IT Trial Paper Won’t Be Published Right Away In The New England Journal Of Medicine
November 13, 2014 by 1 Comment
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. …
Newly Identified Mutations Act Like a Lifetime of Treatment with Ezetimibe
November 13, 2014 by Leave a Comment
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…
What You Need To Know About IMPROVE-IT
November 7, 2014 by Leave a Comment
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…
Cholesterol Drugs Haunted By Ghosts Of Past, Present, And Future
October 2, 2014 by Leave a Comment
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…
Early Hint At Cardiovascular Outcomes With Sanofi’s and Regeneron’s Rapidly Advancing Cholesterol Drug
August 31, 2014 by Leave a Comment
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…
IMPROVE-IT Trial Scheduled For Presentation In November
August 12, 2014 by Leave a Comment
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…
12.8 Million More Adults Now Eligible For Statin Therapy
March 19, 2014 by Leave a Comment
Millions more people are now eligible for statin therapy under the new cholesterol guideline, according to a new estimate published in the New England Journal of Medicine. … There have been many attempts to quantify just how many more people are now eligible for statin therapy under the new guideline. Now in the new paper in NEJM, Michael Pencina…
FDA Sprinkles Some Rain On the PCSK9 Inhibitor Parade
March 7, 2014 by Leave a Comment
In the last few years the PCSK9 inhibitors have been one of the few bright lights in an otherwise dismal field of new cardiovascular drugs. Now the FDA is raising questions that could dramatically slow down the progress of these new cholesterol-lowering drugs. Last month Regeneron disclosed that it had been “advised by the FDA that…
Aegerion Warns About Negative Impact Of DOJ Investigation
March 5, 2014 by Leave a Comment
Earlier this week in its annual report Aegerion Pharmaceuticals provided an update on its ongoing problems with the FDA and the Department of Justice. As previously reported here and on The Street and on CNBC, the company landed in hot water with the FDA last year after its CEO made a series of off-label statements on the CNBC Fast Money show. (The company’s only product, Juxtapid…
Pfizer Starts Testing For Over-The-Counter Lipitor
March 2, 2014 by Leave a Comment
Looking backward to improve its future, Pfizer will once again try to gain FDA approval to market its blockbuster drug, atorvastatin (Lipitor), over-the-counter (OTC). Peter Loftus reports in the Wall Street Journal that the company has started a clinical study to support the application for low-dose atorvastatin (10 mg). … Click here to read the full post on Forbes….
Dispatch From The Wild Frontier Of The Statin Wars
December 13, 2013 by Leave a Comment
The long simmering controversy over the relative benefits and harms of statins has heated to a high boil with the release of the new AHA/ACC US guidelines. But nowhere is the battle more intense right now than in Australia where, according to the National Heart Foundation, a TV show may be the cause of 2,000 heart attacks…
Slouching Toward Phase 3: Progress Report On New Cholesterol Drugs At The AHA
November 25, 2013 by Leave a Comment
The American Heart Association meeting in Dallas this year brought new phase 2 data about several promising new cholesterol drugs. But before jumping on any bandwagons it would be good to remember that even for the drugs most far along in development we still haven’t seen any phase 3 data. In addition, it bears repeating that the…
The Fate Of New Cholesterol Drugs Depends On IMPROVE-IT
November 14, 2013 by Leave a Comment
Prospects for the highly anticipated new class of cholesterol-lowering drugs, the PCSK9 inhibitors, took a wild roller coaster ride this week. The publication of new lipid guidelines by the American Heart Association and the American College of Cardiology led many observers to think that the promising new drugs under development by Regeneron (in partnership with Sanofi),…
After Long Wait, Updated US Cardiovascular Guidelines Now Emphasize Risk Instead Of Targets
November 12, 2013 by 1 Comment
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…
Prevalence Of Cardiovascular Disease Likely To Increase Despite Gains In Treatment
October 9, 2013 by Leave a Comment
It is the best of times and the worst of times in the battle against cardiovascular disease. On the one hand, mortality rates from cardiovascular disease in the US have dropped by more than half in the last 30 years, likely due in large part to improvements in treatment for elevated blood pressure and cholesterol…
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