Efficacy of Three Amoxicillin Doses in Vonoprazan Dual Therapy for Helicobacter pylori Eradication: A Randomized Noninferiority Trial

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2025-06-07 DOI:10.1111/hel.70050

Ruolin Peng, Pengpeng Cai, Zhimei Zhang, Shengxiang Lv, Guangxia Chen, Yuling Xu, Bin He, Min Sun, Xiaorong Dai, Kunfeng Yan, Lu Shen, Jianrong Wang, Wei Li, Rui Yin, Jianxin Ge, Duanmin Hu, Kewei Hu, Xiaodan Xu, Hui Li, Chengyu Pan, Zhaotao Duan, Xuefeng Gao, Zhenyu Zhang, Wanli Liu

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Abstract

Background

Limited research has explored the efficacy of reduced amoxicillin dosages in vonoprazan-amoxicillin (VA) dual therapy for Helicobacter pylori eradication in China, and this study aimed to assess the noninferiority of these lower dosages compared to the standard high dose (3 g/d).

Methods

This was a noninferiority study with a −10% margin. H. pylori-positive patients from 13 centers in Jiangsu Province, China, were randomly assigned in a 1:1:1 ratio to receive a 14-day treatment, consisting of vonoprazan (20 mg BID) and high-dose amoxicillin (1 g TID, HVA), medium-dose amoxicillin (1 g BID, MVA), or low-dose amoxicillin (0.5 g TID, LVA). The eradication rates, adverse events (AEs), and medication adherence were compared.

Results

From January 13, 2023 to July 6, 2024, a total of 900 patients were enrolled. According to the intention-to-treat (ITT) and per-protocol (PP) analyses, the eradication rates for HVA, MVA, and LVA groups were 93.2% and 93.2%, 91.6% and 91.5%, and 87.0% and 86.8%, respectively. The efficacy of MVA was noninferior to HVA in ITT analysis (difference: −1.6%, 97.5% CI: −7.0% to 3.8%, p < 0.001) and PP analysis (difference: −1.7%, 97.5% CI: −7.1% to 3.7%, p < 0.001); LVA's effectiveness was less than HVA in ITT analysis (difference: −6.2%, 97.5% CI: −12.2% to −0.2%, p = 0.076) and PP analysis (difference:-6.4%, 97.5% CI: −12.4% to −0.3%, p = 0.089). The incidence of AEs and medication compliance among the three groups was similar.

Conclusions

A 14-day VA regimen requires ≥ 2 g/d amoxicillin to maintain noninferior eradication efficacy versus 3 g/d, supporting dose reduction without compromising effectiveness.

Trial Registration

ClinicalTrials.gov identifier: NCT05649540

查看原文本刊更多论文

三种阿莫西林剂量在伏诺帕赞双重治疗中根除幽门螺杆菌的疗效：一项随机非劣效性试验

背景有限的研究已经探索了减少阿莫西林剂量在vonoprazan-amoxicillin （VA）双重治疗中根除幽门螺杆菌的疗效，本研究旨在评估这些低剂量与标准高剂量（3g /d）相比的非效性。方法：这是一项非劣效性研究，边际为- 10%。来自中国江苏省13个中心的幽门螺旋杆菌阳性患者按1:1:1的比例随机分配，接受为期14天的治疗，包括vonoprazan （20mg BID）和高剂量阿莫西林（1g TID， HVA）、中剂量阿莫西林（1g BID， MVA）或低剂量阿莫西林（0.5 g TID， LVA）。比较根除率、不良事件（ae）和药物依从性。结果2023年1月13日至2024年7月6日，共入组900例患者。根据意向治疗（ITT）和方案分析（PP）， HVA、MVA和LVA组的根除率分别为93.2%和93.2%，91.6%和91.5%，87.0%和86.8%。在ITT分析（差异：- 1.6%,97.5% CI: - 7.0%至3.8%,p < 0.001）和PP分析（差异：- 1.7%,97.5% CI: - 7.1%至3.7%,p < 0.001）中，MVA的疗效不逊于HVA；ITT分析中LVA的有效性低于HVA（差异：- 6.2%,97.5% CI: - 12.2%至- 0.2%,p = 0.076）和PP分析中LVA的有效性低于HVA（差异：-6.4%,97.5% CI: - 12.4%至- 0.3%,p = 0.089）。三组患者不良事件发生率及用药依从性相似。结论：14天的VA治疗方案需要≥2g /d的阿莫西林来维持非亚差的根除效果，而不是3g /d，支持在不影响效果的情况下减少剂量。临床试验注册。gov标识符：NCT05649540

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来源期刊

Helicobacter 医学-微生物学

CiteScore

8.40

自引率

9.10%

发文量

审稿时长

2 months

期刊介绍： Helicobacter is edited by Professor David Y Graham. The editorial and peer review process is an independent process. Whenever there is a conflict of interest, the editor and editorial board will declare their interests and affiliations. Helicobacter recognises the critical role that has been established for Helicobacter pylori in peptic ulcer, gastric adenocarcinoma, and primary gastric lymphoma. As new helicobacter species are now regularly being discovered, Helicobacter covers the entire range of helicobacter research, increasing communication among the fields of gastroenterology; microbiology; vaccine development; laboratory animal science.