Comparative efficacy and safety of vonoprazan versus esomeprazole-based high-dose dual therapies for first-line Helicobacter pylori eradication: a randomized controlled trial.

IF 3.4 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Therapeutic Advances in Gastroenterology Pub Date : 2025-09-20 eCollection Date: 2025-01-01 DOI:10.1177/17562848251378066

Wei-Chen Tai, Lung-Sheng Lu, Shih-Cheng Yang, Hsin-Ming Wang, Cheng-Kun Wu, Chih-Chien Yao, Pao-Yuan Huang, Yu-Chi Lee, Seng-Kee Chuah, Chih-Ming Liang

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引用次数: 0

Abstract

Background: Effective Helicobacter pylori (H. pylori) eradication depends on maintaining intragastric pH >6 and overcoming antibiotic resistance. High-dose dual therapy (HDDT) with a proton pump inhibitor (PPI) and amoxicillin has shown promising results.

Objectives: To compare the efficacy of 14-day vonoprazan-based (VA) and esomeprazole-based (EA) HDDT for H. pylori eradication and evaluate the impact of antibiotic resistance.

Design: Randomized controlled trial (RCT).

Methods: A total of 121 patients with confirmed H. pylori infection were randomized to receive either VA therapy (vonoprazan 20 mg twice daily plus amoxicillin 750 mg four times daily (QID)) or EA therapy (esomeprazole 40 mg three times daily plus amoxicillin 750 mg QID) for 14 days. Eradication was assessed by the ¹³C-urea breath test at week 8. Antibiotic susceptibility testing was performed on cultured isolates.

Results: Baseline demographic and clinical characteristics were comparable between the VA and EA groups. In the intention-to-treat analysis, eradication rates were 86.9% (95% confidence interval (CI): 78.4%-95.4%) in the VA group and 81.7% (95% CI: 71.3%-89.4%) in the EA group (p = 0.430). Per-protocol (PP) analysis showed eradication rates of 93.0% (95% CI: 86.4%-99.6%) for VA and 84.5% (95% CI: 73.8%-92.1%) for EA (p = 0.150), indicating no statistically significant difference. Adverse events (AEs) were mild and similar between groups (5.3% in VA vs 5.2% in EA, p = 0.983), with constipation and diarrhea being the most reported. Both groups achieved 100% compliance. Antibiotic resistance patterns did not significantly affect outcomes.

Conclusion: Both VA and EA-HDDT regimens demonstrated comparable efficacy, excellent compliance, and minimal AEs. Although VA therapy achieved a >90% eradication rate in the PP analysis, our study was underpowered to confirm superiority. Therefore, larger, adequately powered RCTs are warranted to validate the potential superiority of VA.

Trial registration: ClinicalTrials.gov: NCT06811207.

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伏诺哌赞与以埃索美拉唑为基础的高剂量双重治疗一线幽门螺杆菌根除的疗效和安全性比较：一项随机对照试验

背景：有效根除幽门螺杆菌（h.p ylori）取决于维持胃内pH值bbbb6和克服抗生素耐药性。质子泵抑制剂（PPI）和阿莫西林的大剂量双重治疗（HDDT）显示出有希望的结果。目的：比较以伏诺帕赞（VA）和以埃索美拉唑（EA）为基础的HDDT 14天根除幽门螺杆菌的疗效，并评价抗生素耐药性的影响。设计：随机对照试验（RCT）。方法：121例确诊幽门螺旋杆菌感染的患者随机接受VA治疗（伏诺哌赞20 mg每日2次+阿莫西林750 mg每日4次（QID））或EA治疗（埃索美拉唑40 mg每日3次+阿莫西林750 mg QID），疗程14 d。在第8周通过呼吸试验评估根除情况。对培养菌株进行药敏试验。结果：基线人口统计学和临床特征在VA组和EA组之间具有可比性。意向治疗分析中，VA组根除率为86.9%(95%可信区间（CI）： 78.4% ~ 95.4%)， EA组根除率为81.7% (95% CI: 71.3% ~ 89.4%) （p = 0.430）。按方案（PP）分析显示，VA的根除率为93.0% (95% CI: 86.4% ~ 99.6%)， EA的根除率为84.5% (95% CI: 73.8% ~ 92.1%) (p = 0.150)，差异无统计学意义。组间不良事件（ae）轻微且相似（VA组为5.3%，EA组为5.2%,p = 0.983），以便秘和腹泻报道最多。两组均达到100%的依从性。抗生素耐药模式对结果没有显著影响。结论：VA和EA-HDDT方案均表现出相当的疗效，良好的依从性和最小的不良反应。尽管在PP分析中，VA治疗达到了大约90%的根除率，但我们的研究不足以证实其优越性。因此，需要更大规模、更充分的随机对照试验来验证va的潜在优势。试验注册：ClinicalTrials.gov: NCT06811207。

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来源期刊

Therapeutic Advances in Gastroenterology GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

6.70

自引率

2.40%

发文量

103

审稿时长

15 weeks

期刊介绍： Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area. The editors welcome original research articles across all areas of gastroenterology and hepatology. The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.