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Severe intestinal malabsorption associated with olmesartan: a French nationwide observational cohort study
  1. Mickael Basson1,
  2. Myriam Mezzarobba1,
  3. Alain Weill1,
  4. Philippe Ricordeau1,
  5. Hubert Allemand1,
  6. Francois Alla1,
  7. Franck Carbonnel2
  1. 1French National Health Insurance Fund, Paris, France
  2. 2Université Paris-Sud, Assistance Publique-Hôpitaux de Paris and Gastroenterology unit, Hôpitaux Universitaires Paris Sud, Le Kremlin Bicêtre, France
  1. Correspondence to Dr Franck Carbonnel, Service de Gastroentérologie, CHU de Bicêtre, 78 Rue du Général Leclerc, Le Kremlin Bicêtre 94270, France; fcarbonnel7{at}gmail.com

Abstract

Objectives Severe sprue-like enteropathy associated with olmesartan has been reported, but there has been no demonstration of an increased risk by epidemiological studies.

Aim To assess, in a nationwide patient cohort, the risk of hospitalisation for intestinal malabsorption associated with olmesartan compared with other angiotensin receptor blockers (ARB) and ACE inhibitors (ACEIs).

Design From the French National Health Insurance claim database, all adult patients initiating ARB or ACEI between 1 January 2007 and 31 December 2012 with no prior hospitalisation for intestinal malabsorption, no serology testing for coeliac disease and no prescription for a gluten-free diet product were included. Incidence of hospitalisation with a discharge diagnosis of intestinal malabsorption was the primary endpoint.

Results 4 546 680 patients (9 010 303 person-years) were included, and 218 events observed. Compared with ACEI, the adjusted rate ratio of hospitalisation with a discharge diagnosis of intestinal malabsorption was 2.49 (95% CI 1.73 to 3.57, p<0.0001) in olmesartan users. This adjusted rate ratio was 0.76 (95% CI 0.39 to 1.49, p=0.43) for treatment duration shorter than 1 year, 3.66 (95% CI 1.84 to 7.29, p<0.001) between 1 and 2 years and 10.65 (95% CI 5.05 to 22.46, p<0.0001) beyond 2 years of exposure. Median length of hospital stay for intestinal malabsorption was longer in the olmesartan group than in the other groups (p=0.02). Compared with ACEI, the adjusted rate ratio of hospitalisation for coeliac disease was 4.39 (95% CI 2.77 to 6.96, p<0.0001) in olmesartan users and increased with treatment duration.

Conclusions Olmesartan is associated with an increased risk of hospitalisation for intestinal malabsorption and coeliac disease.

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