Randomized trial of vonoprazan‐based versus proton‐pump inhibitor‐based third‐line triple therapy with sitafloxacin for Helicobacter pylori.

Background and Aim: This was a prospective, randomized trial of the efficacy of vonoprazan‐based and proton‐pump inhibitor‐based 7‐day triple regimens with amoxicillin and sitafloxacin as a third‐line therapy for eradicating Helicobacter pylori after failure of clarithromycin‐based and metronidazole‐based first‐line and second‐line therapy. Methods: We enrolled 63 patients positive for H. pylori in whom first‐line and second‐line regimens for eradicating failed. Patients were randomized to the V‐AS group (vonoprazan 20‐mg bid, amoxicillin 750‐mg bid, and sitafloxacin 100‐mg bid for 7 days) or PPI‐AS group (esomeprazole 20‐mg bid, rabeprazole 10‐mg bid, or lansoprazole 30‐mg bid; amoxicillin 750‐mg bid; and sitafloxacin 100‐mg bid for 7 days). We assessed the outcome of eradication therapy using the 13C‐urea breath test. We evaluated safety using patient questionnaires. This study was registered in the UMIN Clinical Trials Registry (UMIN000016336). Results: The intention‐to‐treat and per‐protocol eradication rates of V‐AS were 75.8% (95% confidence interval [CI]: 57.7–88.9%) and 83.3% (95% CI: 65.3–94.4%), respectively. The respective eradication rates of PPI‐AS were 53.3% (95% CI: 34.3–71.7%) and 57.1% (95% CI: 37.2–75.5%). In per‐protocol analyses, the eradication rate of the V‐AS group was significantly higher than that of the PPI‐AS group (P = 0.043); however, no significant differences were observed in intention‐to‐treat analyses (P = 0.071). Questionnaire scores did not differ significantly between the groups. Conclusions: The findings suggest that 7‐day triple therapy with vonoprazan, amoxicillin, and sitafloxacin is more effective than proton‐pump inhibitor, amoxicillin, and sitafloxacin as a third‐line regimen for eradicating H. pylori. [ABSTRACT FROM AUTHOR]