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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)

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