FDA Says No Cardio Risk with Olmesartan in Diabetes Patients

FDA found no evidence that olmesartan increased cardiovascular risk in diabetes patients

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) After completing a safety review, the US Food and Drug Administration (FDA) found no evidence that the blood pressure medication olmesartan increases cardiovascular risks in people with diabetes.

In light of its findings, the FDA's recommendations for use of olmesartan will not change. However, the agency will require that some of the studies used in the review will need to be included on medication labels.

The FDA conducted this safety review because of results from a trial called ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention). The ROADMAP trial set out to see if olmesartan could slow down kidney damage in people with type 2 diabetes. But the researchers made an unexpected finding: Patients taking olmesartan had a higher risk of heart-related death than those taking placebo (sugar pill).

As a result of this finding, FDA researchers reviewed other studies on the medication. These researchers concluded that the additional studies did not clearly show an increased risk for cardiovascular problems among those taking olmesartan.

Olmesartan is sold under the brand names Benicar, Benicar HCT, Azor and Tribenzor as well as in generic forms. It falls under a class of medications called angiotensin receptor blockers (ARBs). In 2013, an estimated 1.8 million people received a prescription for products containing olmesartan.

According to the FDA, "It is important to take olmesartan and other blood pressure medicines because uncontrolled high blood pressure increases the risks of cardiovascular problems such as heart disease and stroke, as well as kidney failure and other health problems. Do not stop taking olmesartan or any blood pressure medication without first discussing it with your health care professional."

Review Date: 
June 24, 2014
Last Updated:
June 25, 2014