Effient misses Phase III endpoint vs. Plavix

Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) and Eli Lilly and Co. (NYSE:LLY) said Effient prasugrel plus low-dose aspirin missed the composite primary endpoint vs. Plavix clopidogrel plus low-dose aspirin in the Phase III TRILOGY ACS trial to treat acute coronary syndrome patients who were medically managed without revascularization. Effient did not significantly reduce the incidence of cardiovascular death, myocardial infarction or stroke at 30 months in 7,243 patients under 75 years of age compared to the Plavix arm (13.9% vs. 16%, p=0.21). The partners did say that a post hoc exploratory analysis showed a trend for a lower risk of MI, stroke and death among patients treated with Effient beyond one year vs. Plavix. Data were presented at the European Society of Cardiology meeting in Munich and published in the New England Journal of Medicine. Effient is a thienopyridine P2Y12 receptor antagonist, while Plavix is an adenosine diphosphate (ADP) receptor (P2Y12) antagonist. ...