Vonoprazan‐ vs proton‐pump inhibitor‐based first‐line 7‐day triple therapy for clarithromycin‐susceptible Helicobacter pylori: A multicenter, prospective, randomized trial. Issue 2 (21st December 2017)

• Record Type: Journal Article
• Authors: Sue, Soichiro; Ogushi, Marina; Arima, Isao; Kuwashima, Hirofumi; Nakao, Satoshi; Naito, Makoto; Komatsu, Kazuo; Kaneko, Hiroaki; Tamura, Toshihide; Sasaki, Tomohiko; Kondo, Masaaki; Shibata, Wataru; Maeda, Shin
• Is Part Of: Helicobacter. Volume 23:Issue 2(2018)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2017-12-21
• Subjects: 7‐day triple therapy -- clarithromycin‐susceptible -- Helicobacter pylori eradication -- vonoprazan; Helicobacter -- Periodicals; Helicobacter infections -- Periodicals; Stomach -- Diseases -- Periodicals; 616.3301405
• DOI: 10.1111/hel.12456
• Languages: English
• ISSNs: 1083-4389

Abstract

Abstract: Background: The eradication rate of vonoprazan‐based first‐line triple therapy (combined with clarithromycin and amoxicillin) (V‐AC) was reported to be 97.6% in patients with clarithromycin (CAM)‐susceptible Helicobacter pylori in a phase III study, whereas our real‐world, prospective, multicenter cohort study yielded an eradication rate <90%. Objective: To validate the eradication rate of V‐AC using CAM‐susceptible testing in a multicenter, prospective, randomized trial. Methods: We included 147 treatment‐naïve H. pylori ‐positive patients [41 with CAM‐resistant infections and 106 with CAM‐susceptible infections]. The CAM‐susceptible group patients were randomized to either the V‐AC group (vonoprazan 20 mg bid, amoxicillin 750 mg bid, and clarithromycin 200 or 400 mg bid) or PPI‐AC group (lansoprazole 30 mg, rabeprazole 10 mg, or esomeprazole 20 mg bid; amoxicillin 750 mg bid; and clarithromycin 200 or 400 mg bid). All CAM‐resistant H. pylori were eradicated by V‐AC, as measured by the urea breath test around 8 weeks after eradication. Safety was evaluated by patient questionnaires. Results: The intention‐to‐treat and per‐protocol eradication rates of V‐AC in the CAM‐susceptible H. pylori ‐infected patients were 87.3% (95% confidence interval 75.5%‐94.7%) and 88.9% (77.4%‐95.8%). The respective eradication rates of PPI‐AC were 76.5% (62.5%‐87.2%) and 86.7% (73.2%‐94.9%). No significant difference was observed between the V‐AC and PPI‐AC regimes in terms of the intention‐to‐treat ( P = .21) or per‐protocol ( P = .77) analyses. The questionnaire scores did not differ significantly between the groups. Both the intention‐to‐treat and per‐protocol eradication rates of V‐AC in the CAM‐resistant patients were 82.9% (67.9%‐92.8%). Conclusion: The eradication rate of V‐AC treatment in the CAM‐susceptible H. pylori‐ infected patients was <90%, as was that by PPI‐AC, thus V‐AC is not ideal regimen in CAM‐susceptible H. pylori . However, the 82.9% eradication rate of V‐AC in the CAM‐resistant infections may indicate the potential of V‐AC with modified dose, dosing interval, and treatment duration. (UMIN000016337).