Objective To establish the non-inferior efficacy of vonoprazan versus lansoprazole in the treatment of Asian patients with erosive oesophagitis (EO). Design In this phase III, double-blind, multicentre study, patients with endoscopically confirmed EO were randomised 1:1 to receive vonoprazan 20 mg or lansoprazole 30 mg, once daily for up to 8 weeks. The primary endpoint was EO healing rate at 8 weeks. The secondary endpoints were EO healing rates at 2 and 4 weeks. Safety endpoints included treatment-emergent adverse events (TEAEs). Results In the vonoprazan (n=238) and lansoprazole (n=230) arms, 8-week EO healing rates were 92.4% and 91.3%, respectively (difference 1.1% (95% CI –3.822% to 6.087%)). The respective 2-week EO healing rates were 75.0% and 67.8% (difference 7.2% (95% CI –1.054% to 15.371%)), and the respective 4-week EO healing rates were 85.3% and 83.5% (difference 1.8% (95% CI –4.763% to 8.395%)). In patients with baseline Los Angeles classification grade C/D, 2-week, 4-week and 8-week EO healing rates were higher with vonoprazan versus lansoprazole (2 weeks: 62.2% vs 51.5%, difference 10.6% (95% CI –5.708% to 27.002%); 4 weeks: 73.3% vs 67.2%, difference 6.2% (95% CI –8.884 to 21.223); and 8 weeks: 84.0% vs 80.6%, difference 3.4% (95% CI –9.187% to 15.993%)). Overall, EO healing rates appeared higher with vonoprazan versus lansoprazole. TEAE rates were 38.1% and 36.6% in the vonoprazan and lansoprazole group, respectively. Conclusion Our findings demonstrate the non-inferior efficacy of vonoprazan versus lansoprazole in terms of EO healing rate at 8 weeks in this population. Safety outcomes were similar in the two treatment arms. Trial registration number NCT02388724.

中文翻译：

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评估沃诺拉赞与兰索拉唑在亚洲糜烂性食管炎患者中的疗效和安全性的 III 期、随机、双盲、多中心研究

目的 确定沃诺拉赞与兰索拉唑治疗亚洲糜烂性食管炎（EO）患者的非劣效性。设计 在这项 III 期、双盲、多中心研究中，内窥镜确诊 EO 患者按 1:1 随机接受沃诺拉赞 20 mg 或兰索拉唑 30 mg，每天一次，持续长达 8 周。主要终点是 8 周时的 EO 愈合率。次要终点是 2 周和 4 周的 EO 愈合率。安全终点包括治疗中出现的不良事件 (TEAE)。结果 在沃诺拉赞 (n=238) 和兰索拉唑 (n=230) 组中，8 周 EO 愈合率分别为 92.4% 和 91.3%（差异 1.1%（95% CI –3.822% 至 6.087%））。相应的 2 周 EO 愈合率分别为 75.0% 和 67.8%（差异 7.2%（95% CI –1.054% 至 15.371%）），4 周 EO 愈合率分别为 85.3% 和 83.5%（差异 1.8%（95% CI –4.763% 至 8.395%））。在基线洛杉矶分类 C/D 级的患者中，沃诺拉赞与兰索拉唑相比，2 周、4 周和 8 周 EO 愈合率更高（2 周：62.2% 对 51.5%，差异 10.6%（95% CI – 5.708% 至 27.002%）；4 周：73.3% 与 67.2%，差异 6.2%（95% CI –8.884 至 21.223）；8 周：84.0% 与 80.6%，差异 3.4%（95% CI –9.12） 15.993%))。总体而言，与兰索拉唑相比，沃诺拉赞的 EO 愈合率似乎更高。沃诺拉赞和兰索拉唑组的 TEAE 率分别为 38.1% 和 36.6%。结论我们的研究结果表明，就该人群 8 周时的 EO 愈合率而言，vonoprazan 与兰索拉唑的疗效非劣效性。两个治疗组的安全性结果相似。