FDA Approves Prasugrel for PCI Patients

September 2009

The Food and Drug Administration approved the antiplatelet agent prasugrel to reduce the risk of clotting during percutaneous coronary intervention, with labeling that includes a boxed warning about the potential for significant and sometimes fatal bleeding. Prasugrel, a thienopyridine, was approved for reducing thrombotic cardiovascular events, including stent thrombosis, in the following patients with acute coronary syndrome who will be managed with percutaneous coronary intervention (PCI): those with unstable angina or non-ST elevation myocardial infarction (NSTEMI) and those with ST-elevation MI (STEMI), when managed with either primary or delayed PCI.

In the pivotal phase III trial of 13,608 patients with a threatened or actual myocardial infarction who were about to undergo angioplasty, prasugrel (Effient) was more effective than clopidogrel (Plavix) at reducing subsequent nonfatal myocardial infarction (9.1% vs. 7%). Patients with a history of stroke were more likely to have a repeat stroke on prasugrel, however. There was also a greater risk of significant bleeding events with prasugrel. Prasugrel's labeling includes a boxed warning about the bleeding, which advises against using the drug in patients with active pathologic bleeding, a history of transient ischemic attacks or stroke, or urgent need for surgery, including coronary artery bypass graft surgery.


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