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Plavix vs. aspirin

This article was originally published in The Tan Sheet

Executive Summary

Sanofi-Synthelabo cited in May 9 FDA letter for making unsubstantiated superiority claims for its antiplatelet therapy over aspirin. Agency takes issue with Sanofi visual "sales aid" stating Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE) trial demonstrated "significant overall risk reduction vs. aspirin." FDA reiterates finding, stated in December 1998 letter to Sanofi, that CAPRIE trial "does not provide substantial evidence to support the implication that Plavix has superior efficacy over aspirin." Recent letter also cites Plavix visual aid for selectively presenting most favorable relative risk reductions for Plavix vs. aspirin for ischemic stroke and MI but minimizing the component with least favorable relative risk reductions - other vascular death. A recent CAPRIE sub-study found Plavix is superior to aspirin in patients with previous cardiac surgery (1"The Tan Sheet" Jan. 29, p. 18)
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