Although the benefits of statins are among the best documented in all of medicine, continuous lifelong statin therapy is not always easy to achieve in clinical practice. Now a new retrospective study suggests that although clinical events causing temporary cessation of statin therapy occur often, most of these patients are later able to resume statin…

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The U.S. FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA rejected — for the second time — an ACS indication for the oral anticoagulant rivaroxaban (Xarelto), CHMP announced today that it had adopted a positive opinion for the…

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In an exceedingly strange turn of events, data from a clinical trial dating from the 1960s, long thought to be lost, has now been resurrected and may contribute important new information to the very contemporary controversy over recommendations about dietary fat composition. The American Heart Association has long urged people to increase their consumption of…

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No food has had more ups and downs over the last century or so than the common egg. Following a long period in which eggs were ubiquitous and highly regarded, eggs fell from favor with the rise of concerns over cholesterol. Currently, the American Heart Association recommends that people restrict dietary cholesterol to 300 mg per day, which…

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In the wake of the negative HPS2-THRIVE study announced last month, Merck said today that it was beginning to suspend the worldwide availability of Tredaptive, its combination of extended-release niacin and laropiprant. Merck described its decision as being “aligned” with that of the European Medicines Agency’s  Pharmacovigilance Risk Assessment Committee (PRAC), which recommended on Thursday that drugs containing extended-release niacin and laropiprant should be suspended. The…

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William E. Boden, lead investigator of the AIM-HIGH trial, and CardioExchange’s Harlan M. Krumholz debate the current state of research on niacin therapy.

In the wake of HPS2-THRIVE, John Ryan asks William E. Boden, lead investigator of the AIM-HIGH trial, for his perspective on niacin and other HDL-modifying therapies.

A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed “Son…

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The largest-ever study of niacin has failed to show a clinical benefit of niacin and even found a strong signal of harm. Merck announced today that the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study did not meet its primary endpoint. In that study, the combination of a statin and Merck’s niacin compound, Tredaptive, a combination of extended-release niacin and…

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Ranbaxy, the often-troubled manufacturer of generic drugs, will temporarily stop manufacturing generic atorvastatin. On November 9, 2012, the company announced a voluntary recall of some lots of atorvastatin because of possible contamination with glass particles. An FDA statement today said that Ranbaxy will discontinue making the drug “until it has thoroughly investigated the cause of the…

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