Esomeprazole alone compared with esomeprazole plus aspirin for the treatment of aspirin-related peptic ulcers

Am J Gastroenterol. 2012 Jul;107(7):1022-9. doi: 10.1038/ajg.2012.87. Epub 2012 Apr 17.


Background: Aspirin-related peptic ulcers are a common disorder. However, whether or not aspirin should be continued during treatment for aspirin-related ulcers remains unclear.

Aims: To compare esomeprazole alone with esomeprazole plus aspirin in the treatment of aspirin-related peptic ulcers and to investigate the independent factors associated with the failure of ulcer healing.

Methods: From January 2008 to July 2011, patients with aspirin-related peptic ulcers were randomized to receive esomeprazole (40 mg per day) alone or esomeprazole (40 mg per day) plus aspirin (100 mg per day) for 8 weeks. The subjects with Helicobacter pylori infection were treated with standard triple therapy. Follow-up endoscopy was carried out at the end of the 8th week. The primary end point was the healing of peptic ulcers.

Results: In all, 178 patients (89 receiving esomeprazole alone and 89 receiving esomeprazole plus aspirin) were enrolled and underwent follow-up endoscopy. The healing rate of ulcers by modified intention-to-treat analysis was 82.5% (95% confidence interval (CI), 74.2-90.8%) among patients treated with esomeprazole alone and 81.5% (95% CI, 73.0-90.0%) among patients treated with esomeprazole plus aspirin (difference, 1.0%; 95% CI, -11.2 to 12.6%). The per-protocol analysis yielded similar results (healing rate: 83.1% vs. 83.8%, respectively; difference, 0.7%; 95% CI, -11.2 to 12.6%). Multivariate analysis disclosed that use of steroids during treatment (odds ratio: 5.6; 95% CI, 1.1-27.7%) was the only independent factor associated with the failure of ulcer healing.

Conclusions: The observed ulcer healing rates were comparable in the esomeprazole and esomeprazole-plus-aspirin groups, but the wide CIs do not rule out clinically meaningful differences of more than 10%.

Publication types

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

MeSH terms

  • Aged
  • Anti-Ulcer Agents / administration & dosage
  • Anti-Ulcer Agents / adverse effects*
  • Aspirin / administration & dosage
  • Aspirin / adverse effects
  • Aspirin / therapeutic use*
  • Cardiovascular Diseases / prevention & control
  • Chi-Square Distribution
  • Drug Therapy, Combination
  • Esomeprazole / administration & dosage
  • Esomeprazole / therapeutic use*
  • Female
  • Helicobacter Infections / diagnosis
  • Helicobacter pylori
  • Humans
  • Male
  • Peptic Ulcer / chemically induced*
  • Peptic Ulcer / drug therapy*
  • Platelet Aggregation Inhibitors / administration & dosage
  • Platelet Aggregation Inhibitors / adverse effects
  • Platelet Aggregation Inhibitors / therapeutic use*
  • Risk Factors
  • Surveys and Questionnaires
  • Taiwan
  • Treatment Outcome


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