Olmesartan has been linked with increased risk of cardiovascular mortality and sprue-like enteropathy. We compared outcomes between olmesartan and other angiotensin receptor blockers in a large clinical registry of patients with diabetes mellitus. A retrospective cohort analysis using nationwide US-integrated insurance and laboratory claims was performed in 45 185 incident diabetic angiotensin receptor blocker users, including 10 370 (23%) olmesartan users. Hazard ratios were computed using time-dependant Cox models adjusted for sociodemographic characteristics, comorbidities, laboratory data, drug use, healthcare utilization, and the propensity to receive olmesartan. Blood pressure data were unavailable. Subjects were followed up for 116 721 patient-years. The primary end point was all-cause hospitalization or all-cause mortality and occurred in 10 915 (24%) patients. Average age was 54.3±9.6 years, 52% were men, 17% had cardiovascular disease, and 10% chronic kidney disease. Compared with other angiotensin receptor blockers, the adjusted hazard for olmesartan was 0.99 (95% confidence interval, 0.94-1.05) for all-cause hospitalization and mortality; 0.90 (0.62-1.30) for all-cause mortality; 0.99 (0.94-1.05) for all-cause hospital admission; 0.88 (0.78-1.00) for cardiovascular disease-related admission, and 1.09 (0.98-1.20) for gastrointestinal disease-related hospitalization in the overall cohort. Olmesartan use was associated with an adjusted hazard for the primary outcome of 1.11 (0.99-1.24) in subjects with history of cardiovascular disease and 1.21 (1.04-1.41) in subjects with chronic kidney disease. In conclusion, there is no robust signal for harm with olmesartan use. Risk may be increased in kidney disease; thus, given the widespread availability of alternate agents, olmesartan should be used with caution in this subgroup pending further study.
Keywords: angiotensin receptor antagonists; cardiovascular diseases; comparative effectiveness research; hospitalization; mortality; olmesartan.