FDA Actions: New Oral Antiplatelet Agent

FDA Actions: New Oral Antiplatelet Agent

The FDA has approved prasugrel, a new oral antiplatelet agent for use in preventing thrombosis in patients with acute coronary syndrome who are to be managed by angioplasty. The approval was based on a head-to-head trial with clopidogrel (Plavix^®) in patients with a threatened heart attack or who had undergone angioplasty (TRITON-TIMI 38 trial). In the 13,608 patients studied, the rate of nonfatal heart attacks was 7.3% with prasugrel vs 9.5% for clopidogrel. The composite outcome of cardiovascular death, MI, and stroke was 9.9% with prasugrel vs 12.1% with clopidogrel (19% relative risk reduction, P < 0.001); however, major bleeding events were more common with prasugrel than clopidogrel (2.4% vs 1.8%). The rate of recurrent stroke was also slightly higher with prasugrel, prompting the FDA to state that prasugrel should not be used in patients with a history of transient ischemic attacks or stroke. It also should not be used in patients with pathological bleeding or an urgent need for surgery. Whether prasugrel is affected by concomitant administration of a proton pump inhibitor, a problem that has recently come to light with clopidogrel, is currently being investigated. Prasugrel will be marketed in partnership with Lilly and Daiichi Sankyo under the trade name Effient™.