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FDA: No clear link between olmesartan, CV risk among patients with diabetes
The FDA today announced that a safety review of olmesartan indicates no increased risk for CV events among patients with diabetes.
According to a press release, recommendations issued by the agency for the use of olmesartan will not change, but information from some recent studies must be included on the labeling. The angiotensin receptor blocker is marketed as Benicar/Benicar HCT, Azor and Tribenzor (all Daiichi Sankyo), as well as in generic form.
The safety review followed results from the ROADMAP trial, which assessed the efficacy of olmesartan patients with type 2 diabetes on delaying kidney damage. Olmesartan recipients exhibited increased risk for CV-related death compared with placebo recipients, while risk for nonfatal MI was lower among olmesartan participants. The FDA evaluated results from additional studies, including a large study of Medicare recipients, according to the release.
“Overall, we have determined that these studies do not clearly show an increased CV risk,” the agency stated in the release. “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.”
The FDA requested that patients and health care professionals report the incidence of any adverse events from treatment with olmesartan to the FDA MedWatch program.