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In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack
Date:11/4/2007

Investigational compound reduces risk of major cardiovascular events by 19 percent, significantly improves net clinical benefit despite increased

bleeding

TOKYO and INDIANAPOLIS, Nov. 4 /PRNewswire-FirstCall/ -- In the pivotal Phase III head-to-head TRITON TIMI-38 clinical trial, the investigational antiplatelet agent prasugrel produced a highly significant 19 percent reduction in relative risk (p=0.0004) for the composite endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke when compared with clopidogrel (Plavix(R)/Iscover(R)) in the treatment of patients across the full spectrum of acute coronary syndrome undergoing percutaneous coronary intervention.

A significant reduction in the risk for the composite endpoint favoring prasugrel (60 mg loading dose/10 mg maintenance dose) over clopidogrel (300 mg LD/75 mg MD) was observed as early as three days. The absolute difference in this endpoint continued to increase over the course of the 15-month, 13,608- patient trial.

In the important subgroup of patients with diabetes, prasugrel reduced the relative risk of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke by 30 percent (p<0.001). In addition, in the key secondary endpoint of stent thrombosis, prasugrel reduced the recurrence of stent thrombosis (a new clot that develops at the stent site) by 52 percent (p<0.0001).

TRITON also showed that treatment with prasugrel significantly reduced the relative risk of cardiovascular death, non-fatal heart attack and non-fatal stroke by 21 percent in patients with STEMI (ST-elevation myocardial infarction, or high-risk heart attack) (p=0.02) and 18 percent in patients suffering from UA (unstable angina, or chest pain)/NSTEMI (non-STEMI) (p=0.002). In addition, prasugrel-treated patients experienced a 34 percent decline in urgent target vessel revascularization (a procedure to reopen blocked arteries) (p<0.001) and
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SOURCE Eli Lilly and Company
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