Retrospective Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jan 7, 2025; 31(1): 101463
Published online Jan 7, 2025. doi: 10.3748/wjg.v31.i1.101463
Real-world evidence on the efficacy and safety of vonoprazan-amoxicillin dual therapy for Helicobacter pylori treatment in elderly patients
Wen Gao, Jing-Wen Li, Hui Ye, Xue-Zhi Zhang, Jian-Xiang Liu, Hong Cheng
Wen Gao, Jian-Xiang Liu, Hong Cheng, Department of Gastroenterology, Peking University First Hospital, Beijing 100034, China
Jing-Wen Li, School of Medicine, Tsinghua Medicine, Tsinghua University, Beijing 100034, China
Hui Ye, Xue-Zhi Zhang, Department of Traditional Chinese Medicine and Integrative Medicine, Peking University First Hospital, Beijing 100034, China
Co-first authors: Wen Gao and Jing-Wen Li.
Co-corresponding authors: Jian-Xiang Liu and Hong Cheng.
Author contributions: Cheng H, Gao W, Liu JX, Ye H, and Zhang XZ collected patient clinical data; Li JW, Gao W, and Cheng H analyzed the data and wrote the paper. Gao W and Li JW are designated as co-first authors to reflect their equal contributions to the study analysis and writing. Cheng H designed the report; Liu JX supported the study by providing venue support and testing methodology; Cheng H and Liu JX have played important and indispensable roles in experimental design, data interpretation and manuscript preparation as the co-corresponding authors.
Supported by National High Level Hospital Clinical Research Funding (Youth Clinical Research Project of Peking University First Hospital), No. 2023YC27; Capital’s Funds for Health Improvement and Research, No. 2022-2-40711; and National High Level Hospital Clinical Research Funding (Interdepartmental Research Project of Peking University First Hospital), No. 2024IR20.
Institutional review board statement: This study was approved by the Ethics Committee of Peking University First Hospital (No. 2023Y009-001).
Informed consent statement: As a retrospective analysis, this study utilized medical records from previously treated patients, and as such was approved by the ethics committee to waive the requirement for written informed consent.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at chenghong1969@163.com.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Hong Cheng, MD, Professor, Department of Gastroenterology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing 100034, China. chenghong1969@163.com
Received: September 15, 2024
Revised: October 7, 2024
Accepted: October 30, 2024
Published online: January 7, 2025
Processing time: 84 Days and 20.6 Hours
Abstract
BACKGROUND

A dual therapy regimen containing amoxicillin is a common treatment option for the eradication of Helicobacter pylori (H. pylori). While substantial research supports the efficacy and safety of vonoprazan and amoxicillin (VA) dual therapy in the general population, there is still a lack of studies specifically focusing on its safety in elderly patients.

AIM

To evaluate efficacy and safety of VA dual therapy as first-line or rescue treatment for H. pylori in elderly patients.

METHODS

As a real-world retrospective study, data were collected from elderly patients aged 60 years and above who accepted VA dual therapy (vonoprazan 20 mg twice daily + amoxicillin 1000 mg thrice daily for 14 days) for H. pylori eradication in the Department of Gastroenterology at Peking University First Hospital between June 2020 and January 2024. H. pylori status was evaluated by 13C-urease breath test 6 weeks after treatment. All adverse events (AEs) during treatment were recorded.

RESULTS

In total, 401 cases were screened. Twenty-one cases were excluded due to loss to follow-up, lack of re-examination, or unwillingness to take medication. The total of 380 included cases comprised 250 who received VA dual therapy as first-line treatment and 130 who received VA dual therapy as rescue treatment. H. pylori was successfully eradicated in 239 cases (95.6%) in the first-line treatment group and 116 cases (89.2%) in the rescue treatment group. The overall incidence of AEs was 9.5% for both groups. Specifically, 9.2% of patients experienced an AE in the first-line treatment group and 10.0% in the rescue treatment group. Five patients discontinued treatment due to AE, with a discontinuation rate of 1.3%. No serious AE occurred.

CONCLUSION

The VA dual therapy regimen as a first-line treatment and a rescue therapy was effective and safe for elderly patients aged 60 and older.

Keywords: Helicobacter pylori; Vonoprazan; Amoxicillin; Dual therapy; Elderly

Core Tip: Vonoprazan-amoxicillin (VA) dual treatment is as effective as traditional bismuth-based quadruple therapy for the eradication of Helicobacter pylori (H. pylori) in the general population. However, the safety of this regimen in the elderly population is unknown. This real-world study retrospectively analyzed data from elderly patients treated for H. pylori infection. VA dual therapy demonstrated good safety and efficacy in the elderly patients with an eradication rate similar to that of the general population. The findings provided evidence supporting the use of VA dual therapy in elderly patients.