Olmesartan Benefits Outweigh Potential CV Harms, Says FDA

Shelley Wood

April 14, 2011

April 14, 2011 (Silver Spring, Maryland) — The benefits of the angiotensin receptor blocker (ARB) olmesartan (Benicar, Daiichi Sankyo) outweigh its potential risks: that's the conclusion, for now, from a 10-month long FDA safety review announced today [1].

As previously reported by heartwire , the agency first announced it was reviewing adverse events in two olmesartan trials back in June 2010, after a preliminary analysis of the two studies--the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study and the Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial (ORIENT)--pointed to an increased risk of cardiovascular events in diabetic patients taking the drug.

In an alert issued today, the FDA said it "has determined that the benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label." The drug "is not recommended as a treatment to delay or prevent protein in the urine (microalbuminuria) in diabetic patients," the alert notes.

As previously reported by heartwire , news of the FDA safety review was met with a mix of skepticism tinged with uncertainty by hypertension doctors. Most experts who spoke with heartwire after the FDA announcement tended to believe that the findings were likely due to chance and that any true danger signal with the drug would have become apparent sooner: the drug has been on the market for almost a decade. Others, however, conceded that outcomes studies should have been conducted prior to ROADMAP.

As reported by heartwire , results from that trial were presented at last year's European Society of Hypertension (ESH) European Meeting on Hypertension 2010 and have since been published in the New England Journal of Medicine.

The FDA alert states that drug maker Daiichi Sankyo "has agreed to work with the FDA to perform additional studies, as well as conduct additional analyses of completed clinical studies, to obtain more complete information about the cardiovascular risks or benefits of Benicar in various clinical settings." The FDA "will update the public when new information is available," it reads.


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