News - Hypertension Week of March 30, 2003/ Vol. 2 No. 13

FDA Approves New Use for Antihypertensive Drug Cozaar

The U.S. Food and Drug Administration (FDA) has approved a new use for Merck's antihypertensive drug Cozaar (losartan potassium tablets).

The new label states that Cozaar can be used to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but evidence exists that this benefit does not apply to black patients.

Left ventricular hypertrophy, a thickening of the heart's main pumping chamber, is the most common heart abnormality associated with longstanding hypertension. No angiotensin II receptor blocker other than Cozaar had been approved for use in reducing the risk of stroke in patients with hypertension and this heart abnormality.

The new approval is based on a trail involving 9,193 patients that found that a treatment regimen based on Cozaar significantly reduced the risk of stroke by 25 percent in patients with hypertension and left ventricular hypertrophy versus treatment based on the beta-blocker atenolol.

The trial marks the first time an antihypertensive treatment regimen has demonstrated a reduction in the risk of stroke versus another antihypertensive treatment regimen in such patients.

Although the trial showed that black patients with hypertension and left ventricular hypertrophy had a lower risk of stroke on atenolol than on Cozaar, the difference might have been due to chance.

Other sources: Merck