Objective To date, no randomised trials have compared the efficacy of vonoprazan and amoxicillin dual therapy with other standard regimens for Helicobacter pylori treatment. This study aimed to investigate the efficacy of the 7-day vonoprazan and low-dose amoxicillin dual therapy as a first-line H. pylori treatment, and compared this with vonoprazan-based triple therapy.
Design This prospective, randomised clinical trial was performed at seven Japanese institutions. Patients with H. pylori–positive culture test and naive to treatment were randomly assigned in a 1:1 ratio to either VA-dual therapy (vonoprazan 20 mg+amoxicillin 750 mg twice/day) or VAC-triple therapy (vonoprazan 20 mg+amoxicillin 750 mg+clarithromycin 200 mg twice/day) for 7 days, with stratification by age, sex, H. pylori antimicrobial resistance and institution. Eradication success was evaluated by 13C-urea breath test at least 4 weeks after treatment.
Results Between October 2018 and June 2019, 629 subjects were screened and 335 were randomised. The eradication rates of VA-dual and VAC-triple therapies were 84.5% and 89.2% (p=0.203) by intention-to-treat analysis, respectively, and 87.1% and 90.2% (p=0.372) by per-protocol analysis, respectively. VA-dual was non-inferior to VAC-triple in the per-protocol analysis. The eradication rates in strains resistant to clarithromycin for VA-dual were significantly higher than those for VAC-triple (92.3% vs 76.2%; p=0.048). The incidence of adverse events was equal between groups.
Conclusion The 7-day vonoprazan and low-dose amoxicillin dual therapy provided acceptable H. pylori eradication rates and a similar effect to vonoprazan-based triple therapy in regions with high clarithromycin resistance.
Trial registration number UMIN000034140.
- helicobacter pylori - treatment
- antibiotics - clinical trials
- gastric inflammation
- clinical trials
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Contributors SS, TG and CK planned and designed the study. SS and TG wrote the manuscript. SS, RI, HirI, YO, MasO, MN and KK had leadership in each institution and collected data. HisI, MotO and MK made critical revision of the manuscript. All the authors approved the final manuscript.
Funding This study was founded by Nihon University School of Medicine.
Competing interests TG received honorarium from Takeda Pharmaceutical Company Limited, the manufacturer of study drugs.
Patient consent for publication Obtained.
Ethics approval The study protocol was approved by the institutional review board of each participating unit, and the protocol was not changed after the trial commenced.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request. De-identified data sets and protocol of the present study will be made available by reasonable request from the UMIN Individual Case Data Repository (https://www.umin.ac.jp/icdr/index.html).
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