Esomeprazole for prevention and resolution of upper gastrointestinal symptoms in patients treated with low-dose acetylsalicylic acid for cardiovascular protection: the OBERON trial

J Cardiovasc Pharmacol. 2013 Mar;61(3):250-7. doi: 10.1097/FJC.0b013e31827cb626.

Abstract

Although low-dose acetylsalicylic acid (ASA) is recommended for prevention of cardiovascular events in at-risk patients, its long-term use can be associated with the risk of peptic ulcer and upper gastrointestinal (GI) symptoms that may impact treatment compliance. This prespecified secondary analysis of the OBERON study (NCT00441727) determined the efficacy of esomeprazole for prevention/resolution of low-dose ASA-associated upper GI symptoms. A post hoc analysis of predictors of symptom prevention/resolution was also conducted. Helicobacter pylori-negative patients taking low-dose ASA (75-325 mg) for cardiovascular protection who had ≥1 upper GI risk factor were eligible. The patients were randomized to once-daily esomeprazole 40 mg, 20 mg, or placebo, for 26 weeks; 2303 patients (mean age 67.6 years; 36% aged >70 years) were evaluable for upper GI symptoms. The proportion of patients with dyspeptic or reflux symptoms (self-reported Reflux Disease Questionnaire) was significantly lower (P < 0.0001) in those treated with esomeprazole versus in those treated with placebo. Treatment with esomeprazole (P < 0.0001), age >70 years (P < 0.01), and the absence of upper GI symptoms at baseline (P < 0.0001) were all factors associated with prevention/resolution of upper GI symptoms. Together, these analyses demonstrate that esomeprazole is effective in preventing and resolving patient-reported upper GI symptoms in low-dose ASA users at increased GI risk.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Age Factors
  • Aged
  • Anti-Ulcer Agents / administration & dosage
  • Anti-Ulcer Agents / therapeutic use*
  • Aspirin / administration & dosage
  • Aspirin / adverse effects*
  • Aspirin / therapeutic use
  • Cardiovascular Diseases / prevention & control*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Dyspepsia / chemically induced
  • Dyspepsia / epidemiology
  • Dyspepsia / physiopathology
  • Dyspepsia / prevention & control
  • Esomeprazole / administration & dosage
  • Esomeprazole / therapeutic use*
  • Female
  • Gastroesophageal Reflux / chemically induced
  • Gastroesophageal Reflux / epidemiology
  • Gastroesophageal Reflux / physiopathology
  • Gastroesophageal Reflux / prevention & control
  • Gastrointestinal Diseases / chemically induced
  • Gastrointestinal Diseases / epidemiology
  • Gastrointestinal Diseases / physiopathology
  • Gastrointestinal Diseases / prevention & control*
  • Humans
  • Male
  • Middle Aged
  • Platelet Aggregation Inhibitors / administration & dosage
  • Platelet Aggregation Inhibitors / adverse effects*
  • Platelet Aggregation Inhibitors / therapeutic use
  • Risk Factors
  • Secondary Prevention
  • Self Report
  • Upper Gastrointestinal Tract / drug effects*
  • Upper Gastrointestinal Tract / physiopathology

Substances

  • Anti-Ulcer Agents
  • Platelet Aggregation Inhibitors
  • Esomeprazole
  • Aspirin

Associated data

  • ClinicalTrials.gov/NCT00441727