title: Prevention of peptic ulcers with esomeprazole in patients at risk of ulcer development treated with low-dose acetylsalicylic acid: a randomised, controlled trial (OBERON).
abstract: OBJECTIVE
  To determine whether once-daily esomeprazole 40 mg or 20 mg compared with placebo reduces the incidence of peptic ulcers over 26 weeks of treatment in patients taking low-dose acetylsalicylic acid (ASA) and who are at risk for ulcer development.
  
  
  METHODS
  Multinational, randomised, blinded, parallel-group, placebo-controlled trial.
  
  
  METHODS
  Cardiology, primary care and gastroenterology centres (n=240).
  
  
  METHODS
  Helicobacter pylori-negative patients taking daily low-dose ASA (75-325 mg), who fulfilled one or more of the following criteria: age ≥18 years with history of uncomplicated peptic ulcer; age ≥60 years with either stable coronary artery disease, upper gastrointestinal symptoms and five or more gastric/duodenal erosions, or low-dose ASA treatment initiated within 1 month of randomisation; or age ≥65 years. All patients were ulcer-free at study entry.
  
  
  METHODS
  Once-daily, blinded treatment with esomeprazole 40 mg, 20 mg or placebo for 26 weeks.
  
  
  METHODS
  The primary end point was the occurrence of endoscopy-confirmed peptic ulcer over 26 weeks.
  
  
  RESULTS
  A total of 2426 patients (52% men; mean age 68 years) were randomised. After 26 weeks, esomeprazole 40 mg and 20 mg significantly reduced the cumulative proportion of patients developing peptic ulcers; 1.5% of esomeprazole 40 mg and 1.1% of esomeprazole 20 mg recipients, compared with 7.4% of placebo recipients, developed peptic ulcers (both p<0.0001 vs placebo). Esomeprazole was generally well tolerated. Conclusions Acid-suppressive treatment with once-daily esomeprazole 40 mg or 20 mg reduces the occurrence of peptic ulcers in patients at risk for ulcer development who are taking low-dose ASA. Clinical trial registration number ClinicalTrials.gov identifier: NCT00441727.
authors.affiliation: Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, MI 48109, USA. jscheima@med.umich.edu
authors.forename: James M
authors.initials: JM
authors.lastname: Scheiman
authors.forename: P J
authors.initials: PJ
authors.lastname: Devereaux
authors.forename: Johan
authors.initials: J
authors.lastname: Herlitz
authors.forename: Peter H
authors.initials: PH
authors.lastname: Katelaris
authors.forename: Angel
authors.initials: A
authors.lastname: Lanas
authors.forename: Sander
authors.initials: S
authors.lastname: Veldhuyzen van Zanten
authors.forename: Emma
authors.initials: E
authors.lastname: Nauclér
authors.forename: Lars-Erik
authors.initials: LE
authors.lastname: Svedberg
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D001241:Aspirin / Q000009:adverse effects*; D064098:Esomeprazole / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010437:Peptic Ulcer / Q000139:chemically induced / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000897:Anti-Ulcer Agents; D064098:Esomeprazole; D001241:Aspirin