Vonoprazan Versus Tegoprazan-Amoxicillin Dual Therapy for Treatment-Naïve Patients With Helicobacter pylori Infection: A Prospective, Multicenter, Open-Label, Randomized Controlled Study
Abstract
BACKGROUND: High-dose dual therapy (HDDT) has been shown to achieve eradication rates non-inferior to the bismuth quadruple therapy (BQT) in treatment-naïve patients of Helicobacter pylori (H. pylori) infection, with advantages including greater convenience and fewer adverse events. However, the efficacy of different potassium-competitive acid blockers (P-CABs) in HDDT regimens remains incompletely defined due to variations in their pharmacokinetic properties. Therefore, this study aims to evaluate the eradication rates, incidence of adverse events, and compliance of the dual regimens of vonoprazan/tegoprazan combined with amoxicillin in patients with treatment-naïve H. pylori infection.
METHOD: This prospective, multicenter, open-label, randomized controlled clinical trial enrolled newly diagnosed patients with H. pylori infection from six centers in China. All subjects were randomly assigned to the VA group (vonoprazan 20 mg bid+amoxicillin 1 g tid, 14 days) or the TA group (tegoprazan 50 mg bid+amoxicillin 1 g tid, 14 days). The basic information and clinical data of the patients were collected via electronic questionnaires, WeChat, or telephone follow-ups. H. pylori eradication was assessed 4 weeks post-treatment using the urea breath test (UBT). The adverse events and compliance were meticulously recorded throughout the treatment period.
RESULT: Between June 2024 and May 2025, 710 patients were randomly assigned, and 653 subjects were included. In the intention-to-treat…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 653 participants or records.
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