Randomised clinical trial: esomeprazole for the prevention of nonsteroidal anti-inflammatory drug-related peptic ulcers in Japanese patients

Alimentary Pharmacology and Therapeutics, 05/25/2012

Esomeprazole 20 mg once daily is effective and safe in preventing ulcer recurrence in Japanese patients with a definite history of peptic ulcers who were taking an nonsteroidal anti–inflammatory drug (NSAID).


  • Male and female Japanese adult patients (aged ≥20 years) with endoscopically confirmed history of peptic ulcers who required long–term oral NSAID therapy for a chronic inflammatory condition were randomised to 24 weeks' treatment with esomeprazole 20 mg once daily or matching placebo.
  • The primary end point was the Kaplan–Meier estimated proportion of ulcer–free patients.


  • Overall, 343 patients were randomised to treatment (esomeprazole, n=175; placebo, n=168).
  • The Kaplan–Meier estimated ulcer–free rate over the 24–week treatment period was significantly higher (log–rank P<0.001) in esomeprazole–treated patients (96.0%; 95% CI 92.8, 99.1) than in placebo recipients (64.4%; 95% CI 56.8, 71.9).
  • Esomeprazole was effective at preventing peptic ulcers in both Helicobacter pylori–positive and –negative patients (96.3% vs. 95.5% of patients ulcer–free, respectively); however, in the placebo group, the proportion of ulcer–free patients at 24 weeks was markedly lower among H. pylori–positive than –negative patients (59.7% vs. 69.9%).
  • The NSAID type did not seem to affect the estimated ulcer–free rate with esomeprazole.
  • Treatment with esomeprazole was well tolerated.

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