Merck (MRK) Announces Results of COZAAR Study; Increased Dose Reduced Death or Hospitalization from Heart Failure
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Merck's (NYSE: MRK) medicine COZAAR (losartan potassium tablets) 150 mg, administered once daily, significantly reduced the risk of all-cause death or hospitalization due to heart failure compared to a lower 50 mg once daily dose of COZAAR, in a recent study. The Merck-sponsored study compared the safety and efficacy of two doses of COZAAR in patients with chronic heart failure and reduced cardiac function (left ventricular ejection fraction) who were intolerant of angiotensin-converting enzyme (ACE) inhibitors. The results of the study, called HEAAL -- Heart failure Endpoint evaluation of the A-II-Antagonist Losartan -- were presented by researchers during a late breaking clinical trial session at the American Heart Association (AHA) Scientific Sessions 2009.
COZAAR is not indicated in the U.S. for the treatment of patients with chronic heart failure and is not approved for use, for any indication, at the 150 mg dose used in the HEAAL study. COZAAR is an angiotensin II antagonist (AIIA), cardiovascular medicine approved for three indications:
- for the treatment of hypertension and may be used alone or in combination with other antihypertensive agents, including diruetics;
- to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, although there is evidence that this benefit does not apply to black patients.
- for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio >=300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, COZAAR reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation).
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