Ten-day vonoprazan–amoxicillin dual therapy versus 14-day esomeprazole–amoxicillin dual therapy for first-line eradication: a prospective multicenter randomized controlled trial

Ten-day vonoprazan–amoxicillin dual therapy versus 14-day esomeprazole–amoxicillin dual therapy for first-line eradication: a prospective multicenter randomized controlled trial

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Background: The efficacy of the 14-day esomeprazole–amoxicillin (EA) dual therapy in eradicating Helicobacter pylori ( H.pylori ) has been widely discussed previously.Vonoprazan, a novel potassium-competitive acid blocker, presents rapid, potent, and long-lasting acid inhibitory effects compared to esomeprazole.

However, there is currently a scarcity of direct comparisons between the 10-day vonoprazan–amoxicillin (VA) and the 14-day EA dual therapy for H.pylori eradication.Objectives: This study aimed to compare the efficacy and safety of the 10-day VA and the 14-day EA dual therapy for H.

pylori first-line eradication.Design: This study was a prospective, multicenter, open-label, randomized Lumber Support controlled trial.Methods: The study was conducted at 10 hospitals in China.

In total, 570 newly diagnosed H.pylori -infected patients were recruited from April 2023 to February 2024.These patients were randomly assigned to either the 10-day VA group (vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily) or the 14-day EA group (esomeprazole 20 mg four times daily + amoxicillin 750 mg four times daily).

The primary outcome was the eradication rate, with secondary outcomes including adverse events and compliance.Results: The 10-day VA regimen outperformed the 14-day EA regimen in terms of eradication rates in intention-to-treat (ITT) analysis (85.4% vs 76.

7%, p  = 0.008), modified ITT analysis (90.7% vs 84.

8%, p  = 0.036), and per-protocol (PP) analysis (91.1% versus 85.

5%, p  = 0.047).The non-inferiority p -values in all three analyses were less than 0.

001.No statistically significant difference was observed in the incidence of adverse events between the two groups (9.1% vs 11.

7%, p  = 0.308).The 10-day VA regimen demonstrated higher compliance compared to the 14-day EA regimen Lip Gloss ( p  = 0.

006).Conclusion: The 10-day VA dual therapy showed a satisfactory eradication rate of 91.1% (PP analysis), demonstrating good safety and better compliance compared to the 14-day EA dual therapy as the first-line eradication.

Trial registration: This trial was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2300070475) on April 12, 2023.