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Effient® (Prasugrel) Showed Significant 26 Percent Reduction in Cardiovascular Events Over Clopidogrel in New Core Clinical Cohort Population Sub-Analysis of the TRITON-TIMI 38 Pivotal Study
Date:8/15/2011

INDIANAPOLIS and TOKYO, Aug. 15, 2011 /PRNewswire/ -- A new post-hoc sub-analysis of an important set of patients from the TRITON-TIMI 38 study – those identified as the "core clinical cohort" population – showed that treatment with prasugrel (in combination with aspirin) was associated with a 26 percent relative risk reduction in the combined primary endpoint of cardiovascular death, myocardial infarction or stroke, compared to treatment with clopidogrel (8.3 percent vs. 11.0 percent, respectively, p<0.0001).(1) This corresponds to a 2.7 percent absolute risk reduction for patients treated with prasugrel.  The results of this analysis, which also examined clinical outcomes in two other cohorts of patients who were treated for acute coronary syndromes (ACS) and underwent angioplasty with stenting, will help inform appropriate physician prescribing of prasugrel. These data were recently published online in the American Journal of Cardiology.(1)

For this analysis, investigators analyzed three patient clinical cohorts:

  • The core clinical cohort: Patients who were under 75 years of age, weighed 60 kg or more and who had no prior history of stroke or transient ischemic attack (TIA). This group (n=10,804, 79 percent of all study subjects) excluded those patients considered to be at a higher risk for bleeding by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in their regulatory approval of prasugrel and as outlined in prescribing labels for prasugrel tablets in these regions.(1)
  • The non-core cohort: Patients 75 years of age or older or patients who weighed less than 60 kg, but without known prior stroke or TIA (n=2,149; 16 percent of study participants).(1)  The use of prasugrel in patients greater than or equal to 75 years is generally not recommended. If, after a careful individual benefit/risk evaluation by the prescribing physician,
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SOURCE Eli Lilly and Company
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