TRILOGY ACS study results for Efient/Effient (Daiichi Sankyo/Eli Lilly) - 27-Aug-2012

Daiichi Sankyo Company, Limited and Eli Lilly and Company have announced data from the TRILOGY ACS study, a phase III trial comparing Effient/Efient (prasugrel) plus aspirin to clopidogrel plus aspirin in patients with unstable angina (UA) or non-ST elevation myocardial infarction (NSTEMI), who were managed medically without an artery-opening procedure. At 30 months, 13.9 percent of prasugrel patients versus 16.0 percent of clopidogrel patients experienced the combined primary endpoint of heart attack, stroke or cardiovascular (CV) death in patients under 75 years of age, the primary analysis population (HR=0.91; 95% CI: 0.79-1.05). This outcome was not statistically significant (P=0.21).

Different from other large-scale trials, TRILOGY ACS prospectively studied only the UA/NSTEMI population medically managed without revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery). From a safety perspective, TRILOGY ACS showed that rates of TIMI major bleeding events (including life-threatening or fatal bleeds) did not differ significantly between the prasugrel plus aspirin and clopidogrel plus aspirin treatment groups in patients less than 75 years of age or in the overall study population. In patients under age 75, non-CABG TIMI major bleeding occurred in 2.1 percent of prasugrel patients versus 1.5 percent of clopidogrel patients (HR=1.31, 95% CI: 0.81-2.11, P=0.27).

However, the rates of TIMI major or minor bleeding were higher in patients treated with prasugrel (3.3 percent of prasugrel patients versus 2.1 percent of clopidogrel patients; HR=1.54; 95% CI: 1.06-2.23; P=0.02).An analysis performed to account for multiple recurrent ischemic events suggested a lower risk among participants <75 years treated with prasugrel (HR=0.85; 95% CI: 0.72-1.00; P=0.044).

A post-hoc exploratory analysis observed a trend for a lower risk in heart attack, stroke and death among patients treated with prasugrel beyond one year; HRs and 95% CIs for the time period of <12 months versus the time period of >12 months comparing prasugrel versus clopidogrel for the primary efficacy endpoint were 0.99 (0.84-1.16) versus 0.72 (0.54-0.97) (interaction P=0.07). see "Prasugrel versus Clopidogrel for Acute Coronary Syndromes without Revascularization"-Matthew T. Roe,et al.,the TRILOGY ACS Investigators, August 26, 2012 (10.1056/NEJMoa1205512)