June 25, 2014
FDA conducted a safety review evaluating cardiovascular death in patients with diabetes who are taking olmesartan. The safety review was initiated following the results of two clinical trials where cardiovascular deaths were higher in patients receiving olmesartan compared to patients receiving placebo. Two studies, Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP) and Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial (ORIENT), evaluated different outcomes in patients with Type 2 diabetes. The ROADMAP trial included patients without nephropathy and assessed whether olmesartan could delay the development of microalbuminuria. The ORIENT trial included patients with nephropathy and the primary composite endpoint was time to worsening of renal function or death.
FDA evaluated the cardiovascular events reported in the ROADMAP and ORIENT trials, data from large observational studies, and a meta-analysis conducted by the manufacturer of olmesartan. Overall, FDA concluded that olmesartan was not clearly associated with increased cardiovascular risk in patients with diabetes. Patients should continue their olmesartan unless otherwise advised by their healthcare provider. Olmesartan product labels will be updated to include information about the safety review.
Additional information may be found at the following links:
- Drug Safety Communication – June 24, 2014
- MedWatch Safety Alert – April 14, 2011
- Drug Safety Communication – June 11, 2010
June 24, 2014; June 14, 2010; University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.