14-Day Keverprazan-Amoxicillin Dual Therapy Versus Bismuth-Containing Quadruple Therapy as First-Line Treatment for Helicobacter pylori Eradication: A Prospective, Single-Center, Randomized Controlled Trial.

BACKGROUND

Keverprazan, a novel potassium-competitive acid blocker (P-CAB), provides stronger and more sustained gastric acid suppression than proton pump inhibitors (PPIs). However, direct comparisons between 14-day keverprazan-amoxicillin (KA) dual therapy and 14-day bismuth-containing quadruple therapy (BQT) for Helicobacter pylori (H. pylori) eradication remain limited.

OBJECTIVE

This study compared the efficacy and safety of the 14-day KA dual therapy versus BQT as a first-line therapy for H. pylori eradication.

METHODS

This randomized controlled trial (RCT) recruited 316 treatment-naive, H. pylori-infected patients. Participants were randomly assigned to receive either the KA group (keverprazan 20 mg twice daily + amoxicillin 1000 mg three times daily) or the BQT group (esomeprazole 20 mg twice daily + amoxicillin 1000 mg twice daily + clarithromycin 500 mg twice daily + colloidal bismuth pectin 300 mg twice daily). H. pylori eradication rate was the primary outcome. Adverse events and compliance were considered as secondary outcomes.

RESULTS

KA dual therapy was noninferior to BQT in eradication rates across intention-to-treat (ITT) analysis (85.4% vs. 82.9%, noninferiority p = 0.001), modified intention-to-treat (MITT) analysis (92.5% vs. 92.9%, noninferiority p < 0.001), and per-protocol (PP) analysis (93.7% vs. 93.5%, noninferiority p < 0.001). Adverse events were significantly lower in the KA group (19.0%) than in the BQT group (28.5%), p = 0.047.

CONCLUSION

The trial suggested KA dual therapy was a promising first-line therapy, achieving a 93.7% eradication rate in the PP analysis, with favorable safety and similar compliance compared to BQT.

TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2400089303.