OBJECTIVES:

Treatment with the angiotensin II receptor blocker (ARB) olmesartan has been associated with sprue-like enteropathy (SLE), a gastrointestinal condition characterized by intestinal malabsorption (IM) and severe diarrhea. Although this phenomenon is not frequent, it is important to raise clinical awareness in order to avoid delay in taking proper actions. Whether the increased risk of SLE is substance specific or a class effect involving all ARBs is uncertain. This study aims to assess the risk of severe enteropathy associated with ARBs treatment in two European countries (Italy and Germany) using data from large administrative and claim databases.

METHODS:

We obtained data from five Italian Local Healthcare Units and a large German claim database and included patients treated with olmesartan, other ARBs and ACE inhibitors (ACE-i). In the absence of a specific diagnosis code for SLE, ICD codes for unspecified IM, coeliac disease and syndromes of malabsorption were used. Analysis implemented a Poisson regression with robust error variance procedure.

RESULTS:

Patients were divided into three groups: olmesartan (25.591, 5.5%), other ARBs (104.901, 22.5%) and ACE-i patients (334.951, 72.0%). Baseline characteristics were similar overall. The incidence of unspecified IM in ACE-i patients was not different compared to the olmesartan group. In fully adjusted analysis, a higher rate ratio was observed when comparing ARBs patients with the olmesartan group (RR: 2.50, 95% CI 1.21 to 5.19, p 0.01). When ICD codes for coeliac disease were included, no differences were observed.

CONCLUSIONS:

In a large cohort of Italian and German patients, we found that SLE was more common in the group of ARBs patients and we could not confirm previous findings of a higher risk of SLE in olmesartan-only patients. This study suggests that drug-induced SLE should be considered the result of exposure to the class of ARBs rather than a specific drug-related effect.