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| | | ![]() Investigative Prasugrel Reduces Cardiac Events Versus Clopidogrel: Presented at AHA By Ed Susman ORLANDO, FL -- November 6, 2007 -- The investigative antiplatelet agent prasugrel appears to reduce the risk of cardiac-related events compared with clopidogrel in patients undergoing percutaneous coronary interventions, researchers said here at the American Heart Association (AHA) 2007 Scientific Sessions. "Prasugrel was shown to be more potent, work more quickly, and have more consistent antiplatelet effects than standard, approved doses of clopidogrel," said Elliott Antman, MD, Samuel A. Levine Cardiac Care Unit, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts. The trials to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel–Thrombolysis in Myocardial Infarction (TRITON-TIMI 38) trial enrolled 13,608 patients who were assigned to receive prasugrel at a loading dose of 60 mg followed by 10 mg for up to 12 months or clopidogrel loading dose of 300 mg followed by 75 mg daily for up to 12 months. Of the patients on clopidogrel, 12.1% experienced a primary endpoint event: cardiovascular death, myocardial infarction or stroke -- compared with 9.9% of patients receiving prasugrel (P =.0004), Dr. Antman said in a late-breaking session on November 4. He said that 142 patients taking clopidogrel (2.4%) experienced stent thrombosis during angioplasty plus stenting procedures compared with 68 patients taking prasugrel (1.1%), a difference that was statistically significant (P <.0001). However, Dr. Antman said that prasugrel was associated with more bleeding than clopidogrel. Major bleeding associated with percutaneous procedures was experienced by 2.4% of patients on prasugrel compared with 1.8% of patients on clopidogrel (P =.03). The net benefit in outcomes also favored prasugrel. There was no significant difference in overall mortality in the study, he reported. The study was published in the online edition of the New England Journal of Medicine to coincide with the presentation of the study at AHA. The study represents a "huge step forward in showing that greater antiplatelet activity is efficacious in patients undergoing these procedures. The increase in bleeding, however, is going to make it challenging for clinicians to learn how to use this agent," commented Steven R. Steinhubl, MD, Associate Professor, Director of Cardiovascular Education & Clinical Research, Director, Cardiology Fellowship Program, Cardiovascular Research Center, University of Kentucky, Lexington, Kentucky. Dr. Antman noted that in order to perform the double-blind, randomized trial, use of clopidogrel was delayed until after the intervention had occurred and a lower loading dose of clopidogrel was used than is now considered standard. However, he said, these differences in timing of the use of the drug would probably not have made much of a difference in outcomes. Funding for this study was provided by Eli Lilly & Co. and Daiichi Sankyo Co. Ltd.
[Presentation title: Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel (TRITON-TIMI 38). Prasugrel Versus Clopidogrel in Patients With Acute coronary Syndromes. Late Breaker 1]
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