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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

a 42 percent reduction in heart attack with subsequent death from cardiovascular causes (p=0.02).

While the overall incidence of non-CABG (coronary artery bypass grafting) bleeding in TRITON was low in both the prasugrel and clopidogrel treatment groups, prasugrel-treated patients experienced a statistically significant increase in non-CABG (coronary artery bypass grafting) major bleeding compared to clopidogrel-treated patients (2.4 vs. 1.8 percent, or 146 vs. 111 patients, p=0.03), including higher rates of life-threatening bleeding (1.4 vs. 0.9 percent, or 85 vs. 56 patients, p=0.01). Though infrequent, fatal bleeding was statistically more frequent among prasugrel-treated than clopidogrel-treated patients (0.4 percent vs. 0.1 percent, or 21 vs. five patients, p=0.002). However, death from cardiovascular causes occurred less frequently among prasugrel-treated patients than clopidogrel-treated patients (2.1 percent vs. 2.4 percent, or 133 vs. 150 patients, p=0.31), as did all-cause death (3.0 percent vs. 3.2 percent, or 188 vs. 197 patients, p=0.64).

The study identified three distinct patient subpopulations with a higher risk of major bleeding in both treatment arms - patients who were 75 years of age or older, weighed less than 60 kg (132 lbs.), or had a prior history of transient ischemic attack (TIA) or stroke. Researchers are evaluating pharmacokinetic data from several prasugrel studies, including TRITON, to determine whether a lower dose of prasugrel might be appropriate for some patients. Among patients without any of these risk factors (80 percent of the 13,608-patient TRITON study), there was no significant difference in major bleeding between prasugrel- and clopidogrel-treated patients (2 percent vs. 1.5 percent, p=0.17).

Based on an analysis using the combined endpoint of all-cause death, heart attack, stroke and major bleeding, the net clinical benefit for prasugrel compared with clopidogrel was a significant 13 percent reduction in
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SOURCE Eli Lilly and Company
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