Ten-day vonoprazan-amoxicillin dual therapy versus standard fourteen-day Bismuth-based quadruple therapy for first-line Helicobacter pylori eradication: a multicenter randomized clinical trial.,The American Journal of Gastroenterology

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Ten-day vonoprazan-amoxicillin dual therapy versus standard fourteen-day Bismuth-based quadruple therapy for first-line Helicobacter pylori eradication: a multicenter randomized clinical trial.
The American Journal of Gastroenterology ( IF 9.8 ) Pub Date : 2023-11-17 , DOI: 10.14309/ajg.0000000000002592
Tian-Lian Yan ₁ , Jing-Hua Wang ₁ , Xin-Jue He ₁ , Ya-Bi Zhu ₂ , Lin-Jie Lu ₃ , Yan-Jiao Wang ₂ , Zi-Wei Wang ₁ , Jian-Guo Gao ₁ , Cheng-Fu Xu ₁ , Han Ma ₁ , Shuang-Mei Luan ₂ , Lan Li ₁ , Yi Chen ₁

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BACKGROUND AND AIMS Whether 10-day short course vonoprazan-amoxicillin dual therapy (VA-dual) is non-inferior to the standard 14-days bismuth-based quadruple therapy (B-quadruple) against H. pylori eradication has not been determined. This trial aimed to compare the eradication rate, adverse events and compliance of 10-days VA-dual regimen with standard 14-days B-quadruple regimen as first-line H. pylori treatment. METHODS This prospective, randomized clinical trial was performed at three institutions in eastern China. A total of 314 treatment-naive, H. pylori infected patients were randomly assigned in a 1:1 ratio to either 10-days VA-dual group, or 14-days B-quadruple group. Eradication success was determined by 13C-urea breath test at least 4 weeks after treatment. Eradication rates, adverse events, and compliance were compared between groups. RESULTS Eradication rates of VA-dual and B-quadruple groups were 86.0% and 89.2% (P＝0.389), respectively, by intention-to-treat (ITT) analysis; 88.2% and 91.5% (P＝0.338), respectively, by modified ITT (mITT) analysis; and 90.8% and 91.3% (P＝0.884), respectively, by per-protocol (PP) analysis. The efficacy of the VA-dual remained non-inferiority to B-quadruple therapy in all ITT, MITT, and PP analysis. The incidence of adverse events in the VA-dual group was significantly lower compared to the B-quadruple group (P＜0.001). Poor compliance contributed to eradication failure in VA-dual group (P＜0.001), while not B-quadruple group (P＝0.110). CONCLUSIONS The 10-day VA-dual therapy provided satisfactory eradication rates of >90% (PP analysis), lower rates of adverse events compared with standard 14-day B-quadruple therapy as first-line H. pylori therapy. TRAIL REGISTRATION NUMBER ChiCTR2300070100.

更新日期：2023-11-17

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