Date:11/16/2011

nt produced a statistically significant 18 percent reduction in the relative risk of the combined measure of cardiovascular death, nonfatal heart attack or nonfatal stroke compared with Plavix in people with chest pain at rest or milder heart attacks (unstable angina/ non-ST segment myocardial infarction) (9.3 vs. 11.2 percent respectively, p=0.002) and a 21 percent significant reduction in the combined endpoint  in people with more severe heart attacks (ST elevation myocardial infarction) (9.8 vs. 12.2 percent respectively, p=0.019).(3) This corresponds to a 1.9 percent absolute risk reduction for UA/NSTEMI patients treated with Effient and a 2.4 percent absolute risk reduction for STEMI patients treated with Effient.(2) TRITON-TIMI 38 patients treated with Effient also experienced a 50 percent relative risk reduction (corresponding to 1.3 percent absolute risk reduction) in stent-related clots when compared with Plavix, regardless of stent type (1.1 percent vs. 2.4 percent respectively, p<0.001).(2) In TRITON, the risk of non-coronary artery bypass graft (non-CABG) major bleeding, including fatal bleeding, was higher with Effient (2.2 percent incidence) compared with Plavix (1.7 percent incidence) (p=0.029).(2) The rate of TIMI major or minor bleeding was significantly greater with Effient than Plavix (5.0 percent vs. 3.8 percent respectively, p=0.002). The risk of coronary artery bypass graft (CABG) major bleeding, including fatal bleeding, was higher with Effient (13.4 percent incidence) than Plavix (3.2 percent incidence) (p<0.001).(2) In TRITON-TIMI 38, the LD of Plavix was delayed relative to the placebo-controlled trials that supported its approval for ACS.

Compared with the overall study population, a higher risk of serious bleeding among Effient patients was most evident in three distinct patient populations that are readily identifiable: patients who weighed less than 132 lbs (60 kg), patients who were 75 years of age or older and patien
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SOURCE Eli Lilly and Company Copyright©2010 PR Newswire. All rights reserved

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