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King/Wyeth Altace

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Ramipril receives additional indication Oct. 4 to reduce risk of stroke, myocardial infarction and cardiovascular death. The ACE inhibitor was previously approved for treatment of hypertension and congestive heart failure following myocardial infarction. Altace labeling has been updated to highlight data supporting efficacy in diabetic patients. The diabetic subpopulation of the pivotal study had a 25% reduction in the incidence of cardiovascular events when compared to placeb
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