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INDIANAPOLIS and TOKYO, August 15, 2011 /PRNewswire/ –

Analysis evaluated efficacy and safety among three patient sub-groups

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/= 75 years is generally not recommended. If, after a careful individual benefit/risk evaluation by the prescribing physician, treatment is deemed necessary in the patient age group >/= 75 years, then following a 60 mg loading dose, a reduced maintenance dose of 5 mg should be prescribed.(2) – the third group were patients with a self-reported or known history of stroke or TIA prior to enrollment (n=518; 4 percent of study participants). Prasugrel is contraindicated in such patients.(1) – Patients without known prior stroke but with missing baseline weight data were excluded from the analysis as it could not be determined to which final cohort they should be assigned to (n= 137; 1 percent of study participants).(1)

In the core clinical cohort, there were higher bleeding rates in prasugrel patients compared to clopidogrel patients.(1) Appropriate prescribing may help minimize a bleeding risk. Based on the post hoc analysis reported in this paper, in patients in the TRITON-TIMI 38 study who were younger than 75, heavier than 60 kg and with no prior stroke, the difference in the rates of certain types of bleeding (known as non-CABG TIMI major bleeding) was reduced, without adversely impacting the efficacy of prasugrel versus clopidogrel.

Relative bleeding rates were similar across the core and “non-core” groups. In the core group, the rate of TIMI major bleeding was 1.9 percent in prasugrel patients compared to 1.5 percent in clopidogrel patients, corresponding to a 0.4 percent absolute increase and a 24 percent relative increase in prasugrel patients (p= 0.17).(1) In the non-core group, the rate of TIMI major bleeding was 4.1 percent in prasugrel patients compared to 3.4 percent in clopidogrel patients, corresponding to a 0.7 percent absolute increase and a 23 percent relative increase in prasugrel patients (p= 0.40).(1) In both cases findings were not statistically significant.

the rate of TIMI major or minor bleeding was statistically significantly greater with prasugrel than clopidogrel in the core group (3.9 percent vs. 3.0 percent respectively, p=0.033), but not in the non-core group (9.8 percent prasugrel vs. 7.5 percent clopidogrel, p=0.08), although the relative increase in bleeding within these groups were similar.(1)

“This analysis showed that the use of prasugrel in a clinically identifiable population of ACS patients undergoing PCI in the TRITON-TIMI 38 trial significantly improved cardiovascular outcomes, ” said Stephen D Wiviott, M.D., at the TIMI Study Group, Cardiovascular Division, Brigham and Women´s Hospital and Harvard Medical School, Boston, and lead author of the paper.(1)

the analysis found that in >/= 75 year old and low body weight (

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