This study compares the efficacy and safety of a novel reversible H+/K+-ATPase inhibitor, Vonoprazan, combined with low-dose amoxicillin against bismuth-containing quadruple therapy (EBAC) for Helicobacter pylori eradication in treatment-naïve patients. Results demonstrate the dual therapy's non-inferiority in eradication rates while significantly reducing adverse events, improving medication adherence, and offering greater cost-effectiveness.
Literature Overview
This article, 'Comparison of Vonoprazan and Low-Dose Amoxicillin Dual Therapy with Bismuth-Containing Quadruple Therapy for Naïve Helicobacter pylori Eradication' published in the journal Antibiotics, reviews results from a single-center, open-label, randomized controlled trial evaluating the efficacy and safety of Vonoprazan combined with low-dose amoxicillin versus bismuth-containing quadruple therapy (EBAC) for treating H. pylori infections. Trial findings indicate comparable eradication rates between the two regimens, though the dual therapy demonstrated reduced adverse events and improved patient acceptance.
Background Knowledge
Helicobacter pylori (H. pylori) is a Gram-negative bacterium strongly associated with multiple gastric diseases including peptic ulcers and gastric cancer. Current eradication strategies remain critical for reducing gastric cancer incidence and ulcer recurrence. While traditional proton pump inhibitor (PPI)-based triple or bismuth-containing quadruple therapies are first-line recommendations, their effectiveness is limited by acid suppression intensity and antibiotic resistance. Vonoprazan, a novel potassium-competitive acid blocker, offers enhanced and sustained acid suppression independent of CYP2C19 polymorphisms, potentially improving eradication rates. This study aimed to establish whether Vonoprazan with low-dose amoxicillin provides non-inferior eradication rates compared to EBAC while maintaining superior safety and adherence profiles in treatment-naïve H. pylori patients.
Research Methods and Experiments
This single-center, open-label, randomized controlled trial enrolled 504 treatment-naïve adult patients with confirmed H. pylori infection, randomly assigned to either the Vonoprazan-amoxicillin (VA) group or the EBAC quadruple therapy group. Primary endpoints included eradication rates, with secondary endpoints covering adverse event incidence and medication adherence. Eradication was assessed via 13C-urea breath testing. Safety profiles were evaluated through adverse event documentation and severity grading. Adherence was defined as medication compliance ≥80%.
Key Conclusions and Perspectives
Research Significance and Prospects
This study provides high-quality clinical evidence supporting Vonoprazan-low-dose amoxicillin dual therapy as a first-line option for specific patient populations including macrolide-resistant cases, elderly individuals, and polypharmacy-intolerant patients. Future multi-center trials with resistance-guided stratification and broader geographic diversity are needed to validate efficacy, safety, and cost-effectiveness across diverse populations. Additional investigations should explore optimal amoxicillin dosing and treatment duration.
Conclusion
Fourteen-day Vonoprazan combined with low-dose amoxicillin demonstrates comparable H. pylori eradication efficacy to bismuth-containing quadruple therapy while offering superior safety, adherence, and economic advantages. This regimen particularly benefits patients with high antibiotic resistance or intolerance to complex treatments. The study highlights medication adherence as a critical determinant of eradication success, suggesting future clinical practices should emphasize patient education and adherence management. Despite limitations inherent to open-label single-center design, these findings provide important reference for optimizing H. pylori eradication strategies. Cyagen Biosciences offers genetically engineered animal models, phenotypic analysis, and efficacy evaluation services to support mechanistic research and novel therapeutic development for H. pylori-related gastric diseases.
