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FDA Finds Unclear Heart Risks for Diabetics on Benicar

FDA Finds Unclear Heart Risks for Diabetics on Benicar

June 25, 2014 — Despite several clinical trials linking high-dose Benicar (olmesartan) with higher rates of deadly heart attacks and cardiac arrest, the U.S. Food and Drug Administration (FDA) has concluded that Benicar does not raise cardiovascular risks.

The FDA has been reviewing these risks since June 2010, when the ROADMAP and ORIENT clinical trials found that patients with type-2 diabetes who took 40-mg/day Benicar had higher rates of death than patients on a placebo.

During the ROADMAP study, 15 patients on Benicar died, compared to three patients on a placebo. The deaths were mostly caused by heart attack and sudden cardiac death. The study also linked Benicar to an increasing trend of strokes, which was concerning.

Benicar was also linked to an increased risk of death in a massive (300,000 patient-year) study of Medicare patients aged 65 and older. Diabetic patients on 40-mg/day Benicar were twice as likely to die compared to patients on other anti-hypertensive drugs in the ARB class.

However, the FDA concluded that the ROADMAP trial results were “unusual and surprising.” Anti-hypertensive drugs are supposed to reduce cardiovascular events. They were also concerned that results of the Medicare study were not credible because Benicar increased survival for non-diabetic patients, which the FDA said “is not a plausible finding” but did not give further explanation of their reasoning.

Even if Benicar does raise cardiovascular concerns, the FDA believes the benefits outweigh these risks. The Prescribing Information has been updated to include the following warning:

“Overall, these data raise a concern of a possible increased CV risk associated with the use of high-dose olmesartan in diabetic patients. There are, however, concerns with the credibility of the finding of increased CV risk, notably the observation in the large epidemiologic study for a survival benefit in non-diabetics of a magnitude similar to the adverse finding in diabetics.”

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