Bad News Bears: After Scary Headlines Some Patients Stopped Taking Statins

Study provokes discussion about the responsibilities of medical journals and the general media. A new study and surrounding discussion raises important questions about the role and responsibility of researchers, editors, and journalists when tackling topics with potentially life-affecting consequences. The new study, published in the BMJ, found that many people stopped taking statins in the…

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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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Increasing Support For Generic Drugs And Therapeutic Substitution

–But some physicians, perhaps influenced by industry, remain skeptical. Generic drugs and therapeutic substitution (replacing a drug without a generic equivalent with a different but closely related drug in the same general class) are two key ingredients in most recipes to hold down health care costs. Now a package of articles and commentary in JAMA…

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Experts Foresee Major Role For Generic Crestor

— Finally there’s a challenger to the long reign of Lipitor The FDA approval on Friday of the first generic version of Crestor (rosuvastatin calcium) marks the end of an era and the beginning of a major shift in cardiovascular medicine. Over time, as the price of the drug drops with generic competition, it seems…

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FDA Ends Niacin and Fenofibric Acid Combinations With Statins

–“In the absence of benefits, there remain only harms.” The FDA is putting an end to the combined use of statins with two once-popular lipid drugs, niacin and fenofibric acid. On Monday the FDA will announce in the Federal Register that it is withdrawing its approval for indications for coadministration of these drugs with statins…

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How Does HOPE-3 Change Thinking About Primary Prevention?

–The study lends strong support for statins but delivers a mixed message for antihypertensives. The widely reported results of HOPE-3 may bolster the case for primary prevention with statins and blood pressure drugs. But the trial also makes clear that the benefits, though real, are also modest, and may not be evenly distributed between statins…

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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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Experts Question Role For At-Home Statin Intolerance Test

A small laboratory company, Boston Heart Diagnostics, has introduced and is promoting “the first and only at-home saliva laboratory developed test” that it says will help identify people who are likely to experience side effects from taking a statin. The company claims the genetic test “helps patients understand how their bodies will process a statin…

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Studies Suggest Flu Vaccines May Be Less Effective In People Taking Statins

Two new studies published in the Journal of Infectious Diseases offer preliminary evidence that the flu vaccine may not work as well in people taking statins. But there is widespread agreement among experts that the association, much less a demonstration of cause and effect, has not been proven, and that current clinical practice should not be changed because…

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Nissen Urges Prompt Revision Of Cardiovascular Guidelines

Sparked by a new study that once again finds serious flaws in the cardiovascular risk calculator at the heart of the American College of Cardiology/American Heart Association cardiovascular guidelines, Steve Nissen states that “the ACC and AHA should promptly revise the guidelines to address the criticisms offered by independent authorities.” The CV risk calculator is a…

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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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Cheaper Generic Statins Beat Brand-Name Statins in Adherence and Outcomes

A large observational study finds that people who received a prescription for a generic statin were more likely to take their pills than people who received a prescription for a brand-name statin. This increased adherence appeared to lead to a small but significant improvement in outcomes. … Click here to read the full post on Forbes….

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FDA Advisory Panel Offers Cautious Support For Polypill

The controversial polypill took one step closer to reaching the US market after receiving a mostly positive reception from the FDA’s Cardiovascular and Renal Drugs Advisory Committee on Wednesday. The idea for the polypill– which in this case would be composed of aspirin, a statin, and one or more blood pressure drugs– has been kicking around for…

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Statins And Diabetes: A Clearer Picture Emerges

In recent years, the medical community has become increasingly aware that taking statins can result in slightly higher glucose levels, and this can lead to a diagnosis of diabetes in a small but statistically significant number of people. But it has been unclear whether the diagnosis of diabetes in people taking statins also places them…

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Why Guidelines Should Be Waged Like War

(Updated) Here’s a modest proposal: we need fewer and shorter guidelines. In fact, I’d like to propose that guidelines, like war, should be waged only when there is absolute consensus and overwhelming evidence. Anyone interested in the subject is aware that guidelines are in a complete mess. Just in the past two weeks I’ve written about…

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No Retraction For You! Review Panel Exonerates Medical Journal In Statin Kerfuffle

An independent review panel has rejected a demand by a prominent researcher that TheBMJ retract two controversial articles. The report largely exonerates the journal’s editors from any wrongdoing. As previously reported, Rory Collins, a prominent researcher and head of the Cholesterol Treatment Trialists’ (CTT) Collaboration, had demanded that TheBMJ retract two articles that were highly critical of statins. Although TheBMJ issued a correction…

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Guideline Critics Shift Attacks From Beta Blockers To Statins

With the release today of updated European and US guidelines the ongoing controversy regarding beta-blockers appears to be resolved. But that doesn’t necessarily mean there will be an outbreak of guideline peace and harmony. The critics who helped ignite the controversy over beta blockers now say new statin recommendations contained in the guidelines are based on deeply flawed evidence….

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BMJ Names Panel Members To Review Disputed Statin Articles

The BMJ has released the names of an outside expert panel who will decide the fate of two articles that are the subject of a heated dispute. As previously reported, last week the BMJ published a correction to two papers published last year, explaining that both papers had  inaccurately overstated the incidence of the adverse effects of statins. However, a…

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Disappointing Results For Statins In Two NIH Trials

Two NHLBI studies have failed to find any benefit for statin therapy in patients with chronic obstructive pulmonary disease (COPD) and acute respiratory distress syndrome (ARDS). Previous observational studies had raised the possibility that statins, perhaps due to their anti-inflammatory effects, might improve outcomes in people with these serious diseases. But both trials were stopped early by…

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BMJ Articles Critical Of Statins Provoke Kerfuffle

The authors of two BMJ articles have withdrawn statements about the adverse effects of statins. The two papers inaccurately cite an earlier publication and therefore overstate the incidence of adverse effects of statins. As a result, the two papers have drawn much criticism and set off a kerfuffle involving the editor of BMJ and a prominent British trialist who is demanding…

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12.8 Million More Adults Now Eligible For Statin Therapy

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…

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Reassuring News About Statins From Two Very Different Studies

Although clinical trials have consistently demonstrated the benefits of statins, the perception that the drugs can cause serious side effects has prompted some patients to discontinue or not take the drugs. Now two new very different studies, one a large meta-analysis and one a tiny study with only a handful of patients, provide some convincing reassurance…

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Pfizer Starts Testing For Over-The-Counter Lipitor

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….

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Dispatch From The Wild Frontier Of The Statin Wars

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…

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