Merck has received the backing of FDA advisers to market losartan (Ocsaar) for reducing the risk of both fatal and non-fatal strokes in patients with left ventricular hypertrophy (LVH). According to the National Institutes of Health, the condition affects about 20% of hypertensive individuals over the age 55.
If the FDA follows its panel’s advice, Ocsaar would become the first antihypertensive agent in its class to be indicated for the reduction of stroke in hypertensive individuals.
However the company failed to convince the FDA panel that Ocsaar also reduced the risk of MI. The company had submitted a single worldwide study (LIFE) of over 9,000 hypertensive individuals with LVH, who were followed for a minimum of four years and showed that Ocsaar reduced the combined risk of cardiovascular morbidity and mortality by about 13% when compared with a regimen that substituted atenolol
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