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Merck Cozaar gets stroke claim

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Merck's antihypertensive Cozaar (losartan) clears FDA March 25 for reducing the risk of stroke in hypertensive patients with left ventricular hypertrophy. The indication is based on the firm's 9,193-patient LIFE (Losartan Intervention for Endpoint Reduction in Hypertension) study, which compared a Cozaar-regimen to one using the diuretic atenolol. The study found Cozaar significantly reduced the risk of stroke by 25% in patients with hypertension and LVH (p=0.001). Labeling notes, however, that the benefit does not apply to African American patients; African American patients in the study had a lower risk of stroke on atenolol than on Cozaar. At their Jan. 6 meeting, several members of FDA's Cardiovascular & Renal Drugs Advisory Committee suggested that the LIFE study should be interpreted carefully in light of the recent findings of the NIH ALLHAT trial, which raised questions about the efficacy of newer antihypertensives compared to diuretics in reducing stroke ris
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