Vonoprazan-Based Triple Therapy Versus Esomeprazole-Based Triple Therapy for H. pylori Eradication in Adolescents (VONTAPE): A Randomized, Double-Blind Controlled Trial

IF 4.6 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Helicobacter Pub Date : 2025-10-23 DOI:10.1111/hel.70083
Sameh A. Lashen, Mohammed M. Shamseyea, Rasha H. Metwally, Galal Abou-Farrag, Engy S. Elkaragy
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引用次数: 0

Abstract

Background and Aim

While H. pylori infection is more commonly associated with adults, it can affect children with an impact on their well-being. Vonoprazan is effective in the eradication of H. pylori infection in adults. However, its effectiveness in adolescents and children is still being studied. The study aimed to investigate the efficacy of Vonoprazan-based triple therapy (VTT) compared to Esomeprazole-based triple therapy (ETT) for H. pylori eradication in adolescents and children.

Patients and Methods

In a multicenter, double-blind, randomized controlled design, we included 242 participants with H. pylori infection in the age group 10–18 years. They were randomly assigned to either weight-based Esomeprazole/Amoxicillin/Clarithromycin twice daily for 14 days (ETT) or to Vonoprazan 20 mg/weight-based Amoxicillin/Clarithromycin twice daily for 14 days (VTT). The H. pylori eradication was evaluated 8 weeks after therapy. Treatment-related adverse events were reported.

Results

In intention-to-treat analysis, eradication of H. pylori was achieved in 93 (76.9%) of the ETT arm and in 106 (87.6%) of the VTT arm (p = 0.029). In per-protocol analysis, eradication rates were 83% and 92.2% for ETT and VTT, respectively (p = 0.036). There was no difference between the two study arms in terms of overall adverse events (p = 0.46). In the VTT arm, the most frequent adverse events were diarrhea (5.8%) and nausea (6.6%).

Conclusion

Fourteen days of VTT is superior to ETT for H. pylori eradication and is well tolerated in children and adolescents aged between 10 and 18 years.

Clinical Trial Registry

NCT06162949; https://clinicaltrials.gov/study/NCT06162949.

以伏诺帕赞为基础的三联疗法与以埃索美拉唑为基础的三联疗法根除青少年幽门螺杆菌(VONTAPE):一项随机、双盲对照试验。
背景和目的:虽然幽门螺旋杆菌感染更常见于成人,但它也可能影响儿童,影响他们的健康。Vonoprazan对成人幽门螺杆菌感染的根除是有效的。然而,它对青少年和儿童的有效性仍在研究中。该研究旨在探讨以伏诺哌赞为基础的三联疗法(VTT)与以埃索美拉唑为基础的三联疗法(ETT)对青少年和儿童幽门螺杆菌根除的疗效。患者和方法:在一项多中心、双盲、随机对照设计中,我们纳入了242名年龄在10-18岁之间的幽门螺杆菌感染患者。他们被随机分配到以体重为基础的埃索美拉唑/阿莫西林/克拉霉素组,每天2次,持续14天(ETT),或以体重为基础的伏诺哌嗪20 mg/阿莫西林/克拉霉素组,每天2次,持续14天(VTT)。治疗后8周评估幽门螺杆菌根除情况。报告了与治疗相关的不良事件。结果:意向治疗分析中,93例ETT组(76.9%)幽门螺杆菌根除,106例VTT组(87.6%)幽门螺杆菌根除(p = 0.029)。在每个方案分析中,ETT和VTT的根除率分别为83%和92.2% (p = 0.036)。两个研究组在总体不良事件方面没有差异(p = 0.46)。在VTT组中,最常见的不良事件是腹泻(5.8%)和恶心(6.6%)。结论:14天的VTT在根除幽门螺杆菌方面优于ETT,并且在10 ~ 18岁的儿童和青少年中耐受性良好。临床试验注册:NCT06162949;https://clinicaltrials.gov/study/NCT06162949。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Helicobacter
Helicobacter 医学-微生物学
CiteScore
8.40
自引率
9.10%
发文量
76
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.
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