title: Severe intestinal malabsorption associated with olmesartan: a French nationwide observational cohort study.
abstract: Severe sprue-like enteropathy associated with olmesartan has been reported, but there has been no demonstration of an increased risk by epidemiological studies.
  
  
  
  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).
  
  
  
  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.
  
  
  
  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.
  
  
  
  Olmesartan is associated with an increased risk of hospitalisation for intestinal malabsorption and coeliac disease.
authors.affiliation: French National Health Insurance Fund, Paris, France.
authors.forename: Mickael
authors.initials: M
authors.lastname: Basson
authors.affiliation: French National Health Insurance Fund, Paris, France.
authors.forename: Myriam
authors.initials: M
authors.lastname: Mezzarobba
authors.affiliation: French National Health Insurance Fund, Paris, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Weill
authors.affiliation: French National Health Insurance Fund, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Ricordeau
authors.affiliation: French National Health Insurance Fund, Paris, France.
authors.forename: Hubert
authors.initials: H
authors.lastname: Allemand
authors.affiliation: French National Health Insurance Fund, Paris, France.
authors.forename: Francois
authors.initials: F
authors.lastname: Alla
authors.affiliation: Université Paris-Sud, Assistance Publique-Hôpitaux de Paris and Gastroenterology unit, Hôpitaux Universitaires Paris Sud, Le Kremlin Bicêtre, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Carbonnel
mesh_terms: D000328:Adult; D000368:Aged; D057911:Angiotensin Receptor Antagonists / Q000008:administration & dosage / Q000009:adverse effects; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D002446:Celiac Disease / Q000175:diagnosis / Q000453:epidemiology; D005260:Female; D005602:France / Q000453:epidemiology; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects; D015994:Incidence; D007345:Insurance Claim Review / Q000706:statistics & numerical data; D007408:Intestinal Absorption / Q000187:drug effects*; D008286:Malabsorption Syndromes / Q000139:chemically induced / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D057911:Angiotensin Receptor Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D007093:Imidazoles; D013777:Tetrazoles; C437965:olmesartan
keywords: ADVERSE DRUG REACTIONS; CELIAC DISEASE; DRUG TOXICITY; EPIDEMIOLOGY