This article was originally published in Pharmaceutical Approvals Monthly
FDA's Cardiovascular & Renal Drugs Advisory Committee votes unanimously May 1 that a pivotal study of ramipril demonstrated a beneficial effect for the combined endpoint of myocardial infarction (MI), stroke and death from cardiovascular events. In a study of patients at risk of cardiovascular events, the combined endpoint was met by 14% of ramipril patients (651 of 4,645 patients) versus 17.8% of placebo patients (826 of 4,652) with a relative risk of 0.78 (0.70-0.86 95% CI, p<0.001). The committee voted five to four not to approve a claim that ramipril decreases the need for coronary revascularization, saying it might not be an appropriate type of claim. Revascularization was required in 16% of ramipril patients and 18.4% of placebo patients. King told the committee that "the only adverse event is a 5% excess of cough" between ramipril patients (7.3%) and placebo patients (1.8%). Altace is currently indicated for treatment of hypertension and for treatment of heart failure following MI
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