No CV Risk With Olmesartan in Diabetics, Says FDA Review

June 24, 2014

BETHESDA, MD – The US Food and Drug Administration (FDA) has completed its safety review of olmesartan (Benicar, Daiichi Sankyo) in diabetic patients, stating there is no clear evidence of increased cardiovascular risk associated with the angiotensin-receptor blocker (ARB)[1].

The FDA conducted the safety review based on data from a large clinical trial testing whether olmesartan could slow the progression of kidney disease in patients with type 2 diabetes. In the trial, known as Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP), investigators observed that diabetic patients taking olmesartan had an increased risk of dying from cardiovascular causes.

Following on ROADMAP, the FDA also reviewed an epidemiologic study of Medicare patients and found a similar suggestion of increased risk of cardiovascular mortality among the olmesartan-treated diabetic patients. According to the agency, while the results of the Medicare study appear to support ROADMAP, it had doubts about the results.

"There are concerns regarding the credibility of the results of the Medicare study because of the discrepant findings in diabetics and nondiabetics," according to the FDA. "The observation of a large decrease in survival in patients with diabetes taking high doses of olmesartan, coupled with a large increase in survival in nondiabetic patients taking olmesartan—all relative to other drugs of the same class—is not a plausible finding."

As a result, the findings of the FDA review are not conclusive and not indicative of increased cardiovascular risk. The "evidence available at this time does not support changing our recommendations for olmesartan use and does not support recommending that its use be avoided in patients with diabetes," it states. The label, however, will be amended to highlight some of the data from these studies.

In 2011, the FDA announced the 10-month results of its review and said the benefits of olmesartan outweigh its risks "when used for the treatment of patients with high blood pressure according to the drug label." Like the 2011 conclusions, the FDA states today that the "benefits of olmesartan in patients with high blood pressure continue to outweigh the potential risks."


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