Hou Xiaohua, Meng Fandong, Wang Jiangbin, Sha Weihong, Chiu Cheng-Tang, Chung Woo Chul, Gu Liqun, Kudou Kentarou, Chong Chui Fung, Zhang Shutian
Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
J Gastroenterol Hepatol. 2022 Jul;37(7):1275-1283. doi: 10.1111/jgh.15837. Epub 2022 May 5.
Duodenal ulcers, especially caused by increasingly drug-resistant Helicobacter pylori, are a concern in Asia. We compared oral vonoprazan versus lansoprazole for efficacy (healing duodenal ulcers) and safety in non-Japanese Asian patients.
In this phase 3, randomized (1:1), double-blind, double-dummy, parallel-group, non-inferiority study (April 5, 2017, to July 19, 2019), patients with ≥ 1 endoscopically confirmed duodenal ulcer, at 52 hospitals (China, South Korea, and Taiwan), received vonoprazan 20 mg once daily (QD) or lansoprazole 30 mg QD for 6 weeks maximum. Patients with H. pylori received bismuth-containing quadruple therapy including vonoprazan 20 mg twice daily (BID) or lansoprazole 30 mg BID, for 2 weeks, followed by vonoprazan or lansoprazole monotherapy QD (4 weeks maximum). Endpoints were endoscopically confirmed duodenal ulcer healing (Week 4/6; primary) and H. pylori eradication (4 weeks post-treatment; secondary); non-inferiority margins were -6% and -10%, using a two-sided 95% confidence interval (CI).
Of 533 enrolled patients, one was lost to follow-up and one withdrew (full analysis set: 531 patients [vonoprazan, n = 263; lansoprazole, n = 268]; 85.4% = H. pylori positive). Vonoprazan was non-inferior to lansoprazole for duodenal ulcer healing (96.9% vs 96.5%; difference 0.4% [95% CI -3.00, 3.79]). H. pylori eradication rates were 91.5% (vonoprazan) and 86.8% (lansoprazole; difference 4.7% [95% CI -1.28, 10.69]). Vonoprazan and lansoprazole were well tolerated, with similar safety profiles, no new safety signals; no deaths occurred.
Vonoprazan was well tolerated and non-inferior to lansoprazole for duodenal ulcer healing and achieved H. pylori eradication above the clinically meaningful threshold (90%), in non-Japanese Asian patients.
十二指肠溃疡，尤其是由耐药性日益增强的幽门螺杆菌引起的溃疡，在亚洲备受关注。我们比较了口服沃克奥美拉唑与兰索拉唑在非日本亚洲患者中的疗效（十二指肠溃疡愈合情况）和安全性。
在这项3期、随机（1:1）、双盲、双模拟、平行组、非劣效性研究（2017年4月5日至2019年7月19日）中，来自52家医院（中国、韩国和台湾）的内镜检查确诊为十二指肠溃疡且溃疡数量≥1个的患者，接受每日一次20毫克沃克奥美拉唑或每日一次30毫克兰索拉唑治疗，最长治疗6周。幽门螺杆菌阳性患者接受含铋四联疗法，其中包括每日两次20毫克沃克奥美拉唑或每日两次30毫克兰索拉唑，治疗2周，随后接受沃克奥美拉唑或兰索拉唑单药治疗，每日一次（最长4周）。观察终点为内镜检查确认的十二指肠溃疡愈合情况（第4/6周；主要终点）和幽门螺杆菌根除情况（治疗后4周；次要终点）；使用双侧95%置信区间（CI）时，非劣效界值分别为-6%和-10%。
在533名入组患者中，1名失访，1名退出（完整分析集：531名患者[沃克奥美拉唑组，n = 263；兰索拉唑组，n = 268]；85.4%为幽门螺杆菌阳性）。在十二指肠溃疡愈合方面，沃克奥美拉唑不劣于兰索拉唑（96.9%对96.5%；差异0.4%[95% CI -3.00, 3.79]）。幽门螺杆菌根除率分别为91.5%（沃克奥美拉唑组）和86.8%（兰索拉唑组；差异4.7%[95% CI -1.28, 10.69]）。沃克奥美拉唑和兰索拉唑耐受性良好，安全性相似，未出现新的安全信号；无死亡病例。
在非日本亚洲患者中，沃克奥美拉唑耐受性良好，在十二指肠溃疡愈合方面不劣于兰索拉唑，且幽门螺杆菌根除率达到了具有临床意义的阈值（90%）。
