Dexlansoprazole Versus Esomeprazole in Concomitant Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized, Open-Label, Non-Inferiority Trial
Abstract
Background and Aims: Non-bismuth concomitant quadruple therapy is a recommended empirical first-line option for Helicobacter pylori eradication in settings where antimicrobial susceptibility is unknown or clarithromycin resistance is elevated. The proton pump inhibitor (PPI) combined with this regimen may influence eradication through its effect on intragastric acid suppression. Dexlansoprazole, a dual delayed-release PPI formulation, achieves more sustained acid suppression than esomeprazole in pharmacodynamic studies, but head-to-head data on H. pylori eradication are lacking. We aimed to determine whether dexlansoprazole is non-inferior to esomeprazole when combined with an identical 14-day concomitant quadruple regimen. Methods: In this single-center, open-label, randomized, parallel-group, non-inferiority trial conducted at the Department of Gastroenterology, Mohammed VI University Hospital, Agadir, Morocco (August 2025–August 2026), adults with confirmed H. pylori infection were randomized 1:1 to dexlansoprazole 60 mg twice daily or esomeprazole 40 mg twice daily, each combined with amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg, all twice daily for 14 days. The primary outcome was eradication confirmed by urea breath test 4–6 weeks post-treatment, analyzed by intention-to-treat (ITT) and per-protocol (PP), with a pre-specified non-inferiority margin of 10 percentage points. Results: A total of 370 patients were randomized (184 dexlansoprazole, 186…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 370 participants or records.
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