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

BackgroundHelicobacter pylori eradication is a key goal in treating peptic ulcers with H. pylori infection, 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 in H. pylori eradication. 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, whereby H. pylori-positive patients received vonoprazan- or lansoprazole-based bismuth-containing quadruple therapy for the first 2 weeks. H. pylori eradication was determined by a carbon-13 urea breath test at a follow-up visit 4 weeks post-treatment. ResultsThe H. pylori eradication rate was 90.6% with vonoprazan vs 85.2% with lansoprazole (difference: 5.4%; 95% confidence interval [CI]: −0.1, 10.8). H. pylori eradication was 7.1% (95% CI: 1.4, 12.8) and 12.6% (95% CI: 3.9, 22.0) higher in patients aged <65 years and current smokers, respectively, with vonoprazan vs lansoprazole. In the Chinese subpopulation, the H. pylori eradication 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 were H. pylori positive at baseline in the vonoprazan vs lansoprazole arm.ConclusionsH. pylori eradication with vonoprazan-based quadruple therapy was indicated to be non-inferior to lansoprazole-based quadruple therapy and exceeded 90%, a clinically relevant threshold for determining the efficacy of H. pylori eradication regimens. (ClinicalTrials.gov identifier: NCT03050359; NCT03050307).

LC–MS/MS method for quick detection of vonoprazan fumarate in human plasma: Development, validation and its application to a bioequivalence study

“…The pharmacokinetic parameter results for vonoprazan fumarate tablet resembled this in the published literature (Yoneyama et al, 2016). In terms of safety results, the safety was favorable and similar to that in previous reports (Fass et al, 2023; Hou et al, 2022; Jenkins et al, 2015; Parsons & Keeling, 2005; Xiao et al, 2020). Moreover, the two‐cycle crossover design of this trial provided a reference for subsequent BE studies of vonoprazan.…”