Thursday, December 20, 2012

HPS-2 THRIVE misses primary end point: No benefit of niacin/laropiprant

Two studies that now failed to show benefits of niacin. Question for your doctor.
http://www.theheart.org/article/1490635.do?utm_medium=email&utm_source=20121220_breaking&utm_campaign=newsletter

After nearly four years of follow-up, the combination of niacin with the antiflushing agent laropiprant did not significantly reduce the risk of the combination of coronary deaths, nonfatal MI, strokes, or coronary revascularizations compared with statin therapy, according to Merck, the sponsor of the HPS-2 THRIVE trial. In a press release announcing the results, Merck said the combination significantly increased the risk of nonfatal but serious side effects.
Merck announced it will no longer be taking the drug before the US Food and Drug Administration to gain approval. The combination of extended-release niacin and laropiprant, known as Tredaptive or Cordaptive, was approved by European regulators in 2008, but Merck is advising doctors from starting any new patients on the drug.
This is the second major setback for physicians hoping that niacin, a drug that raises HDL-cholesterol levels, might be used clinically to reduce the risk of cardiovascular events. In May 2011, the National Heart, Lung, and Blood Institute (NHLBI)-sponsored  Atherothrombosis Intervention in Metabolic Syndrome with Low HDL Cholesterol/High Triglyceride and Impact on Global Health Outcomes (AIM-HIGH) study, was halted early after showing no benefit of niacin when given in addition to statin therapy.


Why Merck's Niacin Failure Will Scare Drug Researchers

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