The FDA is evaluating data from two clinical trials in which patients with type 2 diabetes taking the blood pressure drug olmesartan (Benicar, Daiichi Sankyo), an angiotensin II receptor blocker (ARB), had a higher rate of death from a cardiovascular cause compared with patients taking a placebo.
The agency said its review is “ongoing” and it has not concluded that Benicar increases the risk of death.
The FDA is reviewing the primary data from the two long-term clinical trials “of concern,” namely ROADMAP and ORIENT, and is considering additional ways to assess the cardiovascular effects of Benicar. In both trials, patients with type 2 diabetes were given either Benicar or placebo to determine if treatment with Benicar would slow the progression of kidney disease. An unexpected finding observed in both trials was a greater number of deaths from a cardiovascular cause (MI, sudden death or stroke) in the Benicar-treated patients compared to placebo.
However, the agency noted that it “currently believes that the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks.”
According to the FDA, ARBs and 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 MI or had heart failure. In these studies, no increased risk of cardiovascular-related death has been reported. In fact, the agency pointed out that some of these studies indicate ARBs and ACEIs are useful treatments for certain patients at high risk for cardiovascular events.
Olmesartan also is sold in combination with hydrocholorothiazide as Benicar HCT for the treatment of high blood pressure.