(RTTNews) -  Merck & Co. Inc. (MRK: News ), Tuesday said an investigational study showed that its heart drug Cozaar 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 the same drug.

The Merck-sponsored study, called HEAAL or Heart failure Endpoint evaluation of the A-II-Antagonist Losartan, compared the safety and efficacy of two doses of Cozaar in patients with chronic heart failure and reduced cardiac function who were intolerant of angiotensin-converting enzyme inhibitors.

The company said, "HEAAL is the first study to examine and document the incremental benefit on clinical outcomes of prescribing a higher dose of an angiotensin II antagonist in patients with heart failure."

The multicenter, event-driven clinical trial enrolled 3,834 patients with symptomatic congestive heart failure intolerant of ACE inhibitor treatment at 255 sites in 30 countries.

The primary composite endpoint of the HEAAL study was all cause death or hospitalization for heart failure and the secondary composite endpoint was all cause death or cardiovascular hospitalization.

Cozaar is a cardiovascular medicine approved for the treatment of hypertension, to reduce the risk of stroke in patients with hypertension, and for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes.

Cozaar is not indicated in the U.S. for the treatment of patients with chronic heart failure and is not approved for use at the 150 mg dose, as used in the HEAAL study.
In a separate development, regarding its investigational oral compound anacetrapib, Merck reported that persistent lipid effects remained in the higher dose arms in a mid-stage trial after stopping active therapy with anacetrapib in patients with dyslipidemia.

Anacetrapib is an investigational oral compound currently in late-stage trials that works by inhibiting the activity of CETP in the blood. CETP inhibition with anacetrapib decreases LDL-cholesterol levels and increases HDL-cholesterol levels. The effect of CETP inhibition on cardiovascular risk has yet to be established.

"The study findings add to the data from the initial Phase IIb efficacy and safety results published in the American Heart Journal in February 2009," the company said.

The company added that it is further conducting a late-stage trial, called DEFINE, to evaluate the safety and efficacy of anacetrapib in patients with coronary heart disease and will provide important information on this compound.

To receive FREE breaking news email alerts for Merck & Co Inc. and others in your portfolio

 1   2   Next Page