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FDA Review Finds No Clear CV Risks for Diabetic Patients Taking Olmesartan

An earlier study prompted the agency’s review

An FDA safety review has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients.

As a result, FDA recommendations for the use of olmesartan (Benicar, Benicar HCT, Azor, Tribenzor, and generics) will remain the same, but the agency will require information about some of the studies to be included in drug labels. Patients are advised to discuss any questions they have about the medication with their health care providers.

This safety review was prompted by the results of the ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial, which examined the effects of olmesartan in patients with type-2 diabetes to see whether the drug could delay kidney damage. There was an unexpected finding of increased risk of cardiovascular death in the olmesartan group compared to the placebo group. However, the risk of nonfatal heart attack was lower in the olmesartan-treated patients.

To evaluate these findings, the FDA reviewed additional studies, including a large study in Medicare patients. That observational study in patients ages 65 years and older examined the rate of death in patients taking olmesartan compared to other ARBs.

In a select group of diabetic patients — those who received only the highest dose of olmesartan (40 mg daily) for longer than 6 months — olmesartan was associated with an increased risk of death (hazard ratio [HR] 2.0; 95% confidence interval [CI], 1.1–3.8) compared with similar patients taking other angiotensin receptor blockers. But the same analysis in nondiabetic patients found that high-dose olmesartan was associated with a decreased risk of death (HR, 0.46; 95% CI, 0.24–0.86) compared to similar patients taking other ARBs.

“The conflicting results in diabetics and non-diabetics are difficult to reconcile and raise uncertainty about the credibility of the findings in either group,” the FDA said. “Moreover, no differences were found between the groups receiving lower doses of olmesartan and groups receiving other angiotensin blockers or in those receiving therapy for less than 6 months.

“Overall, we have determined that these studies do not clearly show an increased cardiovascular risk,” the FDA added. “Thus, the collective 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.”

Olmesartan is an angiotensin receptor blocker. In 2013, approximately 1.8 million patients received a dispensed prescription for olmesartan-containing products from U.S. outpatient retail pharmacies.

The FDA first posted a Drug Safety Communications alerting health care professionals to this issue in June 2010.

Source: FDA; June 24, 2014.

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