Published in:
01-10-2023 | Rabeprazole | Original Article—Alimentary Tract
Comparison of vonoprazan-based with rabeprazole-based dual therapy for treatment-naive patients of Helicobacter pylori infection: a prospective, multi-center, randomized controlled study
Authors:
Ying-Ying Han, Lin Zhou, Yun-Lian Hu, Xiang-Wu Ding, Hui Long, Fei Liu, Ming Xu, Zhen-Yu Zhang, Shuang-Ling Li, Qiu-Yan Wang, Cheng-Xia Su, Yan Chen, Jie Chen, Ya Lin, Pei-Yuan Li
Published in:
Journal of Gastroenterology
|
Issue 12/2023
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Abstract
Background
The application of vonoprazan significantly improved the eradication rate of Helicobacter pylori (H. pylori). This study aimed to compare efficacy and safety of the 10-day vonoprazan–amoxicillin (VA) and 14-day rabeprazole–amoxicillin (RA) dual therapy, and to provide a more efficient, safer, and convenient dual regimen for H. pylori infection.
Methods
This was a prospective, open-label, multi-center, randomized controlled study of treatment-naive patients with H. pylori infection. The participants were randomly assigned to the 10-day VA group with vonoprazan 20 mg Bid plus amoxicillin 1 g Tid or the 14-day RA group with rabeprazole 10 mg Tid plus amoxicillin 1 g Tid. The effectiveness, the adverse events, and the patient compliance of the two groups were compared.
Results
A total of 690 patients were enrolled. The eradication rates of 10-day VA and 14-day RA dual therapy were 89.3% and 84.9% in intention-to-treat (ITT) analysis (P = 0.088); 90.6% and 85.9% by modified intention-to-treat (mITT) analysis (P = 0.059); 91.4% and 86.6% by per-protocol (PP) analysis (P = 0.047). Non-inferiority was confirmed between the two groups (all P < 0.001). No discernible differences were observed in adverse effects and compliance between groups. Poor compliance reduced the eradication efficacy (P < 0.05).
Conclusions
The 10-day VA dual therapy was non-inferior to the 14-day RA dual therapy for H. pylori treatment-naive patients, which should be given priority in the first-line treatment. The application of vonoprazan reduced treatment course and antibiotic use. Patients’ adherence was crucial for the success of eradication.