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- W4293793717 abstract "Abstract Background Helicobacter 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. Methods Patients 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. Results The 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. Conclusions H. 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)." @default.
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- W4293793717 date "2022-08-22" @default.
- W4293793717 modified "2023-10-15" @default.
- W4293793717 title "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" @default.
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- W4293793717 doi "https://doi.org/10.21203/rs.3.rs-1837897/v1" @default.
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