Ten‐day <i>versus</i> 14‐day vonoprazan‐amoxicillin high‐dose dual therapy for <i>Helicobacter pylori</i> eradication in China: A multicenter, open‐label, randomized study
Aiping Lin, Zhi Hui Lin, Yijuan Liu, Shuo Chen, Yanfeng Shao, Feng Qiu, Zhongqin Xiao, Zhangkun Xu, Longqun Chen, L Chen, Weixing Lin, Yongfu Wang, Zhonghua Huang, Zhenqun Lin, Xueping Huang
Abstract
BACKGROUND AND AIM: Only a few studies have investigated the efficacy and safety of different durations of vonoprazan and amoxicillin (VA) high-dose dual therapy for the eradication of Helicobacter pylori. We aimed to compare the efficacy and safety of 10 days versus 14 days of VA high-dose dual therapy for H. pylori eradication. METHODS: This study was conducted in 14 centers in China. A total of 250 patients infected with H. pylori were randomly assigned to Group VA-10 or VA-14. Both groups received the VA dual therapy (vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily). The primary endpoint was the H. pylori eradication rate. Secondary endpoints included adverse events and patient compliance. RESULTS: Group VA-10 achieved eradication rates of 89.60%, 91.06%, and 91.67% as determined by the intention-to-treat (ITT), modified intention-to-treat (MITT), and per-protocol (PP) analysis, respectively. The eradication rates were similar to those in Group VA-14: 91.20%, 93.44%, and 93.39%. The difference and 90% confidence interval boundary -1.60% (-7.73% to 4.53%) in the ITT analysis, -2.39% (-8.00% to 3.23%) in the MITT analysis, and -1.72% (-7.29% to 3.85%) in the PP analysis were greater than the predefined noninferiority margin of -10%, establishing a noninferiority of Group VA-10 versus Group VA-14 (noninferiority P = 0.001 in ITT analysis, P < 0.001 in MITT analysis, and P < 0.001 in PP analysis, respectively). No significant differences were observed in adverse events between the two groups. CONCLUSIONS: Ten-day VA dual therapy achieves comparable efficacy and safety to the 14-day regimen in Chinese population, providing patients with greater convenience and economic benefits.