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Daiichi Sankyo/Lilly Respond to ACCF/AHA Clinical Alert on Antiplatelet Therapy
Date:6/28/2010

ificant bleeding, which in TRITON-TIMI 38 was significantly higher with Effient when compared with clopidogrel."

As pointed out in the Clinical Alert, research has shown other factors beyond genetics can negatively impact response to clopidogrel in some ACS-PCI patients. These factors include diabetes status, heart attack severity, stent type and concomitant medications.

In TRITON-TIMI 38, Effient produced reductions in the primary composite endpoint of CV death, nonfatal heart attack or nonfatal stroke that were consistent with that observed in the overall UA/NSTEMI and STEMI populations.  In the UA/NSTEMI population, the rate of the primary composite endpoint was 10 percent in patients with diabetes treated with Effient versus 15 percent in patients with diabetes treated with clopidogrel.  In the STEMI population, the rate of the primary composite endpoint was 9 percent in patients with diabetes treated with Effient versus 13.6 percent in patients with diabetes treated with clopidogrel.  In TRITON-TIMI 38 patients with diabetes, the risk of non-CABG TIMI major or minor bleeding was 4.9 percent for Effient versus 4.5 percent for clopidogrel.  In STEMI patients, the risk of non-CABG TIMI major or minor bleeding was 4.8 percent for Effient versus 4.5 percent for clopidogrel.  In the overall population TRITON-TIMI 38, the rates of non-CABG TIMI major or minor bleeding were 4.9 percent for prasugrel and 3.4 percent for clopidogrel (p=0.002).  

In TRITON-TIMI 38, there were 50 percent fewer stent thromboses (p<0.001) reported among patients randomized to Effient (0.9 percent) than among patients randomized to clopidogrel (1.8 percent).  The differences manifested early and were maintained though one year of follow-up, and findings were similar with bare metal and drug-eluting stents.

Finally, Effient can b
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SOURCE Eli Lilly and Company
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