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Head-to-Head Study Showed Prasugrel Statistically Superior to Clopidogrel in Reducing Recurrent Cardiovascular Events
Date:8/21/2008

g prasugrel, there were 58 recurrent events compared with 115 recurrent events in the clopidogrel group.

-- The risk of cardiovascular death after a heart attack while on therapy was significantly reduced with prasugrel (3.7%) compared with clopidogrel (7.1%).

-- Diabetics treated with prasugrel showed a risk reduction of 60 percent in subsequent events (P=0.003).

-- Even after adjusting for variables such as age, gender, tobacco use and other health conditions, those taking prasugrel still showed a statistically significant reduction of 34 percent in recurrent events (P=0.024).

-- While recurrent bleeding events occurred infrequently among patients with at least one TIMI non-CABG major or minor bleeding (17 in the prasugrel group and 13 in the clopidogrel group), the analysis noted the high percentage of discontinuation following an initial major bleeding event, which were similar among those patients taking prasugrel (42%) and those taking clopidogrel (43%).

"Not only do multiple heart events increase healthcare costs due to additional hospitalizations, tests and physician visits, but they also result in higher morbidity for many patients," said Elliott Antman, M.D., director of the Samuel A. Levine Cardiac Unit at Brigham and Women's Hospital (BWH) in Boston and principal investigator with the BWH-based TIMI Study Group for the TRITON-TIMI 38 clinical trial.

Methodology

TRITON-TIMI 38 was a Phase III, randomized, double-blind, head-to-head clinical trial comparing the effects of prasugrel versus clopidogrel in patients with ACS who were managed with PCI, a procedure to open blockages in heart arteries, including the use of coronary stenting. The study enrolled 13,608 patients at 707 trial sites in 30 countries.

The primary endpoint of the study was to compare the effects of prasugrel to clopidogrel on the combined incidence of cardiovascular death, non-fatal heart attack or non-fatal stroke during a median p
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SOURCE Eli Lilly and Company
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