FDA review clears Olmesartan of CV risk in diabetic patients- Daiichi Sankyo

The FDA has completed its safety review and 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 use of Olmesartan (Benicar, Benicar HCT, Azor, Tribenzor, and generics) will remain the same, but the FDA will require information about some of the studies to be included in the drug labels.

This safety review was prompted by the results of the ROADMAP trial. The ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial examined the effects of Olmesartan in patients with Type 2 Diabetes, to see whether olmesartan could delay kidney damage. There was an unexpected finding of increased risk of cardiovascular death in the Olmesartan group compared to the group taking a placebo, or sugar pill. However, the risk of non-fatal heart attack was lower in the Olmesartan-treated patients.