Although this approval is good news for Merck, and for many patients, the new stroke risk indication is based on the landmark LIFE trial, which indicated that this benefit does not apply to black patients.
In March 2003, the FDA approved the same indication for Merck’s antihypertensive drug Cozaar (losartan potassium tablets). Hyzaar (losartan potassium-hydrochlorothiazide tablets) and Cozaar are the only angiotensin II receptor blockers (ARBs) to be indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy (LVH).
In addition to the new indication for Hyzaar to reduce the risk of stroke in patients with hypertension and LVH, Hyzaar is also the only combination antihypertensive product that is indicated for initial use in appropriate patients with severe hypertension