Regional multi-center randomized trial of three vonoprazan-amoxicillin dosing regimens for Helicobacter pylori eradication in Sichuan Province, China
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…
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: 1,717 participants or records.
Read the paper
Related studies
- Ferulic acid regulates the AKT/GSK-3β/CRMP-2 signaling pathway in a middle cerebral artery occlusion animal model
- Novel Pharmacokinetic/Pharmacodynamic Parameters Quantify the Exposure–Effect Relationship of Levofloxacin against Fluoroquinolone-Resistant Escherichia coli
- Photochemical behavior of levofloxacin
- Correlation Between Dissolution Profiles of Salt-Form Drugs in Biorelevant Bicarbonate Buffer and Oral Drug Absorption: Importance of Dose/ Fluid Volume Ratio
- Evaluation of the synergistic potential and mechanisms of action for de novo designed cationic antimicrobial peptides
- Synthesis of [11C]levofloxacin
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.