In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of He... (overall events (12.2 vs. 13.9 p0.004). I...)

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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

overall events (12.2 vs. 13.9, p=0.004). In the subpopulations defined as being at greater risk of bleeding, the net clinical benefit was not different between prasugrel- and clopidogrel-treated patients (p=0.43). Without the subpopulations defined as being at greater bleeding risk, the net clinical benefit was 20 percent (10.2 vs. 12.5, p<0.001).

Overall, for every 1,000 people treated with prasugrel compared to clopidogrel in the study, there were 23 fewer heart attacks and an additional six major bleeding complications.

"Our study provides compelling evidence that the prasugrel regimen tested is superior to standard dose clopidogrel as an antiplatelet therapy to support patients undergoing coronary stenting," said Elliott Antman, M.D., senior investigator with the TIMI Study Group at Harvard Medical School and director of the Samuel A. Levine Cardiac Unit at Brigham and Women's Hospital in Boston. "With the data from TRITON and other studies, we expect to define populations at particular bleeding risk to help establish clear guidance for using this promising therapy."

Antman announced the initial study results today at the American Heart Association's 2007 Scientific Sessions in Orlando, Florida (abstract 07-LBCT- 20660-AHA). Prasugrel is being co-developed by Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY).

"The TRITON data demonstrate the statistical superiority of this new antiplatelet therapy to prevent heart attacks, and validate our decision to test prasugrel head to head against clopidogrel," said J. Anthony Ware, M.D., Lilly cardiovascular platform leader for prasugrel. "We are very pleased with the trial's outcome and are excited by the potential for these
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