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.
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