Helicobacter · 2025
Vonoprazan-Based Triple Therapy Versus Esomeprazole-Based Triple Therapy for H. pylori Eradication in Adolescents (VONTAPE): A Randomized, Double-Blind Controlled Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Lashen Sameh A, Shamseyea Mohammed M, Metwally Rasha H, Abou-Farrag Galal, Elkaragy Engy S
Аннотация
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.
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.