Does TRITON Really Show If Effient Was Better Than Plavix?
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
The pivotal TRITON-TIMI 38 trial supporting the approval of Lilly/Daiichi Sankyo's Effient (prasugrel) was a lot of things that FDA likes: big (nearly 14,000 patients), long (a median 14.5 months of treatment) and clearly focused on clinical outcomes (the primary endpoint was a composite of cardiovascular death, non-fatal MI, and non-fatal stroke)