Randomised clinical trial: esomeprazole for the prevention of nonsteroidal anti-inflammatory drug-related peptic ulcers in Japanese patients
Alimentary Pharmacology and Therapeutics, 05/25/2012Sugano K et al.
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.
MDLinx connects healthcare professionals and patients to tomorrow's important medical news, while providing the pharmaceutical and healthcare industries with highly targeted interactive marketing, education, content, and medical research solutions.