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Aspirin alternative gets FDA’s okay
ROCKVILLE, Md.-A platelet inhibitor that’s a shade better than aspirin has won expedited FDA approval.
Indicated for patients who’ve had an MI or ischemic stroke or have peripheral-artery disease, clopidogrel (Plavix, Sanofi and Bristol-Myers Squibb) was cleared on the basis of a 400-center, three-year trial of 19,185 patients. It lowered the risk of a repeat MI or ischemic stroke by about a third, vs. about 25% for aspirin-an 8.7% advantage.
Patients in the worldwide CAPRIE trial (Clopidogrel vs. Aspirin in Patients at Risk of Ischemic Events) had a 0.7% ulcer rate, vs. 1.2% for aspirin.
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