Last June, the FDA investigated the blood pressure drug olmesartan (Benicar, Daiichi Sankyo) after two clinical trials showed that the drug increased the rate of death from a cardiovascular cause in patients with type 2 diabetes. Last week, the agency ruled that the drug's benefits outweigh its potential risks, but only in high blood pressure patients.
While the FDA said the drug is not recommended as a treatment to prevent protein in the urine of diabetic patients, they said results of the ROADMAP and ORIENT trials confirmed that the drug had benefits in these patients when it was administered according to the drug label.
The drug’s developer Daiichi Sankyo agreed to work with the FDA to conduct future clinical trials and analyses to gain more information about the drug’s potential CV risks.
During the ROADMAP and ORIENT trials, patients received either olmesartan or placebo and researchers evaluated whether the drug would slow the progression of kidney disease when administered to type 2 diabetics . Both trials showed that the drug increased the rate of deaths from CV causes—MI, sudden death or stroke. However, the agency then noted that it believed the drug's benefits in hypertension patients outweighed these risks.
The FDA said it will update the public when more information becomes available.