Merck & Co says that the US Food and Drug Administration has approved a new indication for its hypertension drug, Hyzaar (losartan potassium-hydrochlorothiazide). The drug is now indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy – a thickening of the heart’s main pumping chamber, the left ventricle.
The new approval was based on data from the so-called LIFE study, which included over 9,000 patients and showed that the originator drug, Cozaar (losartan), significantly reduced the risk of stroke (fatal and nonfatal) by 25% in patients with hypertension and LVH versus treatment with a regimen based on the beta-blocker, atenolol.
The firm said that but there is evidence that this benefit does not apply to black patients, but it added that, given the difficulty in interpreting subset differences in large trials, it cannot be known whether the observed difference is the result of chance.
According to American Heart Association statistics, each year an estimated 700,000 Americans experience a new or recurrent stroke. Stroke is the third leading cause of death and a leading cause of severe, long-term disability in the US.