World J Gastroenterol. 2025 Dec 21;31(47):114377. doi: 10.3748/wjg.v31.i47.114377.
ABSTRACT
BACKGROUND: Helicobacter pylori (H. pylori) infection is highly prevalent worldwide, and rising antibiotic resistance has reduced the efficacy of standard therapy, underscoring the need for simplified and better-tolerated regimens.
AIM: To evaluate the efficacy, safety, and optimal dosing of vonoprazan (VPZ)-amoxicillin (AMO) dual therapy in a non-inferiority randomized trial for H. pylori eradication.
METHODS: In this multi-center, randomized trial conducted at 17 hospitals in Sichuan Province, China, 1717 adults with confirmed infection were assigned (1:1:1) to 14-day regimens: (1) VPZ 20 mg BID + AMO 0.5 g QID; (2) 0.75 g QID; or (3) 1.0 g TID. The primary endpoint was the eradication rate based on intention-to-treat (ITT) and per-protocol (PP) analyses; secondary endpoints included adverse events (AEs) and treatment compliance.
RESULTS: Eradication rates were consistently high (92.35%-97.43%). In the 0.5 g QID group, ITT and PP eradication rates were 93.3% (95%CI: 91.2-95.1) and 97.4% (95%CI: 95.7-98.5), respectively, with no significant differences among groups (P > 0.05). Compliance ranged from 98.1% to 98.3%, and AEs were infrequent (5.2%-7.5%), predominantly mild gastrointestinal symptoms, which occurred least often in the 0.5 g QID group.
CONCLUSION: VPZ-AMO dual therapy achieved excellent eradication, safety, and patient compliance. All regimens were similarly effective, whereas the 0.5 g QID dosing strategy offered the most favorable balance of efficacy and tolerability, supporting its use as a first-line option in high-prevalence settings.
PMID:41479756 | PMC:PMC12754164 | DOI:10.3748/wjg.v31.i47.114377
