The FDA ( Food and Drug Administration ) is evaluating data from two clinical trials in which patients with type 2 diabetes taking the blood pressure medication, Benicar ( Olmesartan ) had a higher rate of death from a cardiovascular cause compared to patients taking a placebo.

FDA's review is ongoing and the Agency has not concluded that Olmesartan increases the risk of death. FDA currently believes that the benefits of Olmesartan in patients with high blood pressure continue to outweigh its potential risks.

The Agency plans to review the primary data from the two studies of concern, ROADMAP and ORIENT, and is considering additional ways to assess the cardiovascular effects of Olmesartan.

ROADMAP and ORIENT are both long-term clinical trials. In both trials, patients with type 2 diabetes were given either Olmesartan or placebo to determine if treatment with Olmesartan would slow the progression of kidney disease. An unexpected finding observed in both trials was a greater number of deaths from a cardiovascular cause ( myocardial infarction, sudden death, or stroke ) in the Olmesartan-treated patients compared to placebo.

Olmesartan is in the class of drugs called angiotensin II receptor blockers ( ARBs or sartans ). These drugs and a closely related group of drugs called angiotensin-converting enzyme inhibitors ( ACEIs ) have been evaluated in many studies involving thousands of patients at high-risk for cardiovascular events, such as patients who had a previous myocardial infarction or had heart failure. No increased risk of cardiovascular-related death has been reported in these trials and, in fact, some of these studies indicate ARBs and ACEIs are useful as treatments for certain patients at high-risk for cardiovascular events.

In the United States, Olmesartan is also sold in combination with Hydrocholorothiazide as Benicar HCT for the treatment of hypertension.

Source: FDA, 2010

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