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.