Use of olmesartan and enteropathy outcomes: a multi‐database study

Summary Background Multiple case reports suggest that olmesartan may be linked to sprue‐like enteropathy; however, few epidemiological studies have examined this association and results have been mixed. Aim To assess whether olmesartan is associated with a higher rate of enteropathy vs other angiotensin II receptor blockers (ARBs). Methods We conducted a cohort study among ARB initiators in 5 US claims databases representing different health insurance programmes. Cox regression models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for enteropathy‐related outcomes, including coeliac disease, malabsorption, concomitant diagnoses of diarrhoea and weight loss, and non‐infectious enteropathy, comparing olmesartan initiators to initiators of other ARBs after propensity score (PS) matching. Results We identified 1 928 469 eligible patients. The unadjusted incidence rates were 0.82, 1.41, 1.66 and 29.20 per 1000 person‐years for coeliac disease, malabsorption, concomitant diagnoses of diarrhoea and weight loss, and non‐infectious enteropathy respectively. HRs after PS matching comparing olmesartan to other ARBs were 1.21 (95% CI, 1.05‐1.40), 1.00 (95% CI, 0.88‐1.13), 1.22 (95% CI, 1.10‐1.36) and 1.04 (95% CI, 1.01‐1.07) for each outcome. HRs were larger for patients aged 65 years and older (eg for coeliac disease, 1.57 [95% CI, 1.20‐2.05]), for patients receiving treatment for more than 1 year (1.62 [95% CI, 1.24‐2.12]), and for patients receiving higher cumulative olmesartan doses (1.78 [95% CI, 1.33‐2.37]). Conclusions This large‐scale, multi‐database study found a higher rate of enteropathy in olmesartan initiators as compared to initiators of other ARBs, although the absolute incidence rate was low in both groups.