Daiichi Sankyo, Eli Lilly Report TRITON TIMI-38 Results

In a Phase III trial, the investigational antiplatelet agent prasugrel reduced relative risk for cardiovascular death, nonfatal heart attack or nonfatal stroke 19 percent when compared with clopidogrel in the treatment of patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI).

Japanese drugmaker Daiichi Sankyo and Eli Lilly conducted the multicenter, randomized, double-blind, parallel-group, head-to-head TRITON TIMI-38 trial. The study enrolled 13,608 patients in 30 countries.

Patients were assigned to one of two treatment groups and given a loading dose of either prasugrel 60 mg or clopidogrel 300 mg anytime between randomization and one hour after the completion of the PCI, followed by a daily maintenance dose of either prasugrel 10 mg or clopidogrel 75 mg. All patients received a daily dose of aspirin.

John Alexander, Daiichi Sankyo’s global head of R&D, said the companies are finalizing the submission packet for prasugrel and hope to send it to the FDA by the end of the year.