Plavix and PPIs

Executive Summary

Medco is adding evidence that proton pump inhibitors may reduce the effectiveness of Plavix (clopidogrel) and thus increase the risk of major cardiovascular events, based on a recent retrospective claims analysis. The analysis focused on medical/pharmacy claims for 16,690 patients who had undergone PCI and were started on Plavix, 9,862 who were taking the antiplatelet drug alone and 6,828 taking clopidogrel and a PPI. Over 12 months, the relative risk of a major adverse cardiovascular event was 50 percent higher and the relative risk of a heart attack specifically was 74 percent in patients taking both drugs. Medco has provided the results to FDA, which is reviewing the study, and is issuing its own alert. Aetna recently announced a retrospective claims analysis with similar findings (1"The Pink Sheet," Oct. 6, 2008, p. 8)