FDA Approves New Drug to Prevent Heart Attacks

The FDA approved the antiplatelet agent, vorapaxar (Zontivity, Merck Sharp & Dohme), to reduce the risk of heart attack, stroke, and cardiovascular death in patients who have previously had a heart attack or have peripheral arterial disease.

Vorapaxar, a protease-activated receptor-1 (PAR-1) antagonist, is a tablet designed to decrease the tendency of platelets to clump together to form a blood clot.
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Zontivity increases the risk of bleeding and should not to be used on people who have had a stroke, transient ischemic attack, or intracranial hemorrhage.

“In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5% to 7.9% over a 3-year period – about 0.5% per year,” said Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. 

In a clinical trial of 25,000, vorapaxar—when added to other antiplatelet agents (eg, aspirin and clopidogrel) —reduced the rate of heart attack, stroke, cardiovascular death, and coronary revascularization when compared to placebo.   

Reference:

FDA. FDA approves Zontivity to reduce the risk of heart attacks and stroke in high-risk patients [press release]. 2014 May 8. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm396585.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed May 9, 2014.