Affiliation:
1. Department of Gastroenterology, Yokohama City University Graduate School of Medicine, Yokohama 236-0004, Japan
2. Department of Gastroenterology, Yokosuka City Hospital, Yokosuka 240-0195, Japan
Abstract
Aim: This was a prospective, multicenter, single-arm intervention, against historical controls, study of the efficacy of a vonoprazan-based 7-day triple regimen with metronidazole (VPZ-AMPC-MNZ) as a first-line therapy for eradicating clarithromycin-resistant Helicobacter pylori (H. pylori). Methods: We enrolled 35 patients positive for clarithromycin-resistant H. pylori, as assessed by culture, without a history of eradication. These 35 patients were prospectively eradicated with VPZ-AMPC-MNZ. As historical controls, we also assessed 98 patients with clarithromycin-resistant H. pylori from our prior prospective studies, who achieved H. pylori eradication with a 7-day triple regimen including clarithromycin (VPZ-AMPC-CAM). A preplanned analysis was performed as a superiority study against the historical controls (VPZ-AMPC-MNZ compared to VPZ-AMPC-CAM). In each regimen, vonoprazan was used at 20 mg bid, amoxicillin at 750 mg bid, metronidazole at 250 mg bid, and clarithromycin at 200 mg or 400 mg bid for 7 days. We assessed the outcome of eradication therapy using a 13C-urea breath test or H. pylori stool antigen test. We evaluated safety using patient questionnaires. Results: The intention-to-treat (ITT) and per-protocol (PP) eradication rates of VPZ-AMPC-MNZ were both 100% (95% confidence interval (95% CI) 90.0–100%, n = 35). The eradication rates of VPZ-AMPC-CAM were 76.5% (95% CI 66.9–84.5%, n = 98) in the ITT analysis and 77.3% (95% CI 67.7–85.2%, n = 97) in the PP analysis. The eradication rate of VPZ-AMPC-MNZ was significantly higher than that of VPZ-AMPC-CAM in both the ITT (p = 0.00052) and PP (p = 0.00095) analyses. Conclusions: The findings suggest that 7-day VPZ-AMPC-MNZ was superior to 7-day VPZ-AMPC-CAM as a first-line regimen for eradicating clarithromycin-resistant H. pylori. We suggest VPZ-AMPC-MNZ as the standard first-line regimen for eradication of clarithromycin-resistant H. pylori in Japan.
Reference30 articles.
1. Association Between Helicobacter pylori Eradication and Gastric Cancer Incidence: A Systematic Review and Meta-analysis;Lee;Gastroenterology,2016
2. The fight against gastric cancer-the IARC Working Group report;Herrero;Best Pract. Res. Clin. Gastroenterol.,2014
3. Roadmap to eliminate gastric cancer with Helicobacter pylori eradication and consecutive surveillance in Japan;Asaka;J. Gastroenterol.,2014
4. Current progress toward eradicating Helicobacter pylori in East Asian countries: Differences in the 2013 revised guidelines between China, Japan, and South Korea;Lee;World J. Gastroenterol.,2014
5. Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: A phase III, randomised, double-blind study;Murakami;Gut,2016
Cited by
3 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献