Prasugrel Assessed in Acute STEMI Patients

February 27, 2009—Daiichi Sankyo Company, Ltd (Tokyo, Japan) and Eli Lilly and Company (Indianapolis, IN), the makers of prasugrel, announced the publication of results from a prespecified analysis of the phase 3 TRITON-TIMI 38 (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis in Myocardial Infarction 38) study by Professor Gilles Montalescot, MD, et al in The Lancet (2009;373:723-731). This analysis assessed the effect of prasugrel versus clopidogrel in the acute ST-elevation myocardial infarction (STEMI) population undergoing percutaneous coronary intervention (PCI). The data showed that PCI patients with the most severe form of acute coronary syndrome (ACS) achieved a significant reduction in relative risk of the combined endpoint of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke at both 30 days and 15 months when treated with prasugrel compared with clopidogrel.

According to the companies, this analysis of the TRITON-TIMI 38 study showed a significant reduction in cardiovascular events in patients with STEMI treated with prasugrel compared with clopidogrel in as early as 30 days (32%; P =.0017) and continued for up to 15 months (21% reduction; P =.0221). In addition, a similar safety profile was seen in both the prasugrel and clopidogrel groups. Although the overall study population, which included patients with unstable angina, non-STEMI, and STEMI, showed a significant increase in TIMI major bleeding for patients on prasugrel, in the STEMI subpopulation, there was no significant increase of noncoronary artery bypass graft-related TIMI major or minor bleeding during the trial period. This analysis of 3,534 STEMI patients, who were enrolled in the TRITON-TIMI 38 trial, represented the first large analysis evaluating prasugrel, as well as clopidogrel, in this patient population undergoing PCI, the companies stated.