Efficacy and safety of vonoprazan-based quadruple therapy for the eradication of Helicobacter pylori in patients with peptic ulcers: a pooled analysis of two randomized, double-blind, double-dummy, phase 3 trials
Abstract
AbstractBackgroundHelicobacter pylorieradication is a key goal in treating peptic ulcers withH. pyloriinfection, a disease highly prevalent in Asia. We present a pooled analysis of two randomized, double-blind, double-dummy, phase 3 studies to evaluate the efficacy and safety of vonoprazan-based bismuth-containing quadruple therapy inH. pylorieradication.MethodsPatients aged ≥18 years with endoscopically confirmed duodenal or gastric ulcers were randomized 1:1 to receive vonoprazan 20 mg or lansoprazole 30 mg once daily for up to 6 or 8 weeks, wherebyH. pylori-positive patients received vonoprazan- or lansoprazole-based bismuth-containing quadruple therapy for the first 2 weeks.H. pylorieradication was determined by a carbon-13 urea breath test at a follow-up visit 4 weeks post-treatment.ResultsTheH. pylorieradication rate was90.6% with vonoprazan vs 85.2% with lansoprazole (difference: 5.4%; 95% confidence interval [CI]: −0.1, 10.8).H. pylorieradication was 7.1% (95% CI: 1.4, 12.8) and 12.6% (95% CI: 3.9, 22.0) higher in patients aged H. pylorieradication rate was 92.0% with vonoprazan vs 86.0% with lansoprazole (difference: 6.1%; 95% CI: 0.5, 11.7). Treatment‑emergent adverse events occurred in 72.7% vs 62.6% of patients who wereH. pyloripositive at baseline in the vonoprazan vs lansoprazole arm.ConclusionsH. pylorieradication with vonoprazan-based quadruple therapy was indicated to be non-inferior to lansoprazole-based quadruple therapy and exceeded 90%, a clinically…
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Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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