Does the use of olmesartan to control hypertension increase cardiovascular complications in patients with type 2 diabetes mellitus (DM)?

Updated: Jul 13, 2021
  • Author: Romesh Khardori, MD, PhD, FACP; Chief Editor: George T Griffing, MD  more...
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In a safety review, the FDA found no clear evidence of increased cardiovascular risk with the hypertension drug olmesartan in diabetic patients. [336] This review addressed data from the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study, which found an increased risk of cardiovascular mortality in patients taking olmesartan, as well as data from an epidemiologic study of Medicare patients, which suggested a similarly increased risk.

Because of discrepant survival results in diabetics and nondiabetics in the Medicare study, the FDA concluded that the evidence for the increased cardiovascular risk was not conclusive and did not support recommending that olmesartan not be used in patients with diabetes. [336, 337]

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