Merck & Co's Cozaar gets US approval for stroke prevention.

Pharma Marketletter, March, 2003

Merck & Co's angiotensin II receptor antagonist Cozaar (losartan) has become the first and only antihypertensive to be approved in the USA for reducing the risk of stroke in patients with high blood pressure and left ventricular hypertrophy, which can be a precursor to heart failure. However, new labeling for the product indicates that this benefit is not achieved in black patients.

The new indication is based on the landmark LIFE study, which was published last March in The Lancet. Approval in this indication was recommended by a US Food and Drug Administration advisory panel in January (Marketletter January 13).

The study randomized patients to either atenolol (50mg-100mg/day) or losartan (50-100mg/day), with treatment designed to match the desired target...