In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of He...( Investigational compound reduces ris...),Health

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

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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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