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