Murakami Kazunari, Sakurai Yuuichi, Shiino Madoka, Funao Nobuo, Nishimura Akira, Asaka Masahiro
Department of Gastroenterology, Faculty of Medicine, Oita University, Oita, Japan.
Takeda Pharmaceutical Company Ltd., Osaka, Japan.
Gut. 2016 Sep;65(9):1439-46. doi: 10.1136/gutjnl-2015-311304. Epub 2016 Mar 2.
The objective of this study was to assess the efficacy, safety and tolerability of vonoprazan, a novel potassium-competitive acid blocker, as a component of Helicobacter pylori eradication therapy.
A randomised, double-blind, multicentre, parallel-group study was conducted to verify the non-inferiority of vonoprazan 20 mg to lansoprazole 30 mg as part of first-line triple therapy (with amoxicillin 750 mg and clarithromycin 200 or 400 mg) in H pylori-positive patients with gastric or duodenal ulcer history. The first 50 patients failing first-line therapy with good compliance also received second-line vonoprazan-based triple therapy (with amoxicillin 750 mg and metronidazole 250 mg) as an open-label treatment.
Of the 650 subjects randomly allocated to either first-line triple therapy, 641 subjects completed first-line therapy and 50 subjects completed second-line therapy. The first-line eradication rate (primary end point) was 92.6% (95% CI 89.2% to 95.2%) with vonoprazan versus 75.9% (95% CI 70.9% to 80.5%) with lansoprazole, with the difference being 16.7% (95% CI 11.2% to 22.1%) in favour of vonoprazan, thus confirming the non-inferiority of vonoprazan (p<0.0001). The second-line eradication rate (secondary end point) was also high (98.0%; 95% CI 89.4% to 99.9%) in those who received second-line therapy (n=50). Both first-line triple therapies were well tolerated with no notable differences. Second-line triple therapy was also well tolerated.
Vonoprazan is effective as part of first-line triple therapy and as part of second-line triple therapy in H pylori-positive patients with a history of gastric or duodenal ulcer.
NCT01505127.
本研究旨在评估新型钾离子竞争性酸阻滞剂沃克奥美拉唑作为幽门螺杆菌根除治疗组成部分的疗效、安全性和耐受性。
开展一项随机、双盲、多中心、平行组研究，以验证在有胃溃疡或十二指肠溃疡病史的幽门螺杆菌阳性患者中，20毫克沃克奥美拉唑作为一线三联疗法（联合750毫克阿莫西林和200或400毫克克拉霉素）的一部分，是否不劣于30毫克兰索拉唑。前50例一线治疗失败但依从性良好的患者还接受了以沃克奥美拉唑为基础的二线三联疗法（联合750毫克阿莫西林和250毫克甲硝唑），作为开放标签治疗。
在随机分配至一线三联疗法的650名受试者中，641名受试者完成了一线治疗，50名受试者完成了二线治疗。沃克奥美拉唑组的一线根除率（主要终点）为92.6%（95%置信区间89.2%至95.2%），兰索拉唑组为75.9%（95%置信区间70.9%至80.5%），差异为16.7%（95%置信区间11.2%至22.1%），支持沃克奥美拉唑，从而证实了沃克奥美拉唑的非劣效性（p<0.0001）。接受二线治疗的患者（n=50）的二线根除率（次要终点）也很高（98.0%；95%置信区间89.4%至99.9%）。两种一线三联疗法耐受性均良好，无显著差异。二线三联疗法耐受性也良好。
在有胃溃疡或十二指肠溃疡病史的幽门螺杆菌阳性患者中，沃克奥美拉唑作为一线三联疗法的一部分以及二线三联疗法的一部分均有效。
NCT01505127。
