SILVER SPRING, Md. The Food and Drug Administration said Friday it was evaluating data from two clinical trials of a hypertension drug to investigate a possible risk of cardiovascular-related death in diabetic patients.
The two trials, “ROADMAP” and “ORIENT,” compared Daiichi Sankyo’s Benicar (olmesartan medoxomil) with placebo in patients with Type 2 diabetes. Still, the FDA cautioned that it had not concluded that Benicar raises the risk of death and said that the drug’s benefits for patients with hypertension outweighed its potential risks.
The FDA said it would review the primary data from the two studies, which were designed to determine whether Benicar slowed the progression of kidney disease in Type 2 diabetes patients.
Benicar and Benicar HCT (olmesartan modoxomil and hydrochlorothiazide) had combined U.S. sales of around $971 million, according to Daiichi Sankyo financial data, based on current yen-dollar exchange rates.