| Autor: |
Hou X; Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology., Wang J; Department of Gastroenterology, China-Japan Union Hospital, Jilin University., Du Q; Department of Gastroenterology, The Second Affiliated Hospital, Zhejiang University School of Medicine., Tian D; Department of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology., Hu N; Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University., Liu D; Department of Gastroenterology, The Second Xiangya Hospital of Central South University., Zhou F; Takeda Pharmaceutical Company Ltd., Xie L; Takeda Pharmaceutical Company Ltd., Gu L; Takeda Development Center Asia., Kudou K; Takeda Pharmaceutical Company Ltd., Zhang S; Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University. |
| Abstrakt: |
Helicobacter pylori eradication is crucial in the treatment of peptic ulcers caused by H. pylori infection, a disease highly prevalent in Asia. We present a pooled analysis of two randomized, double-blind, double-dummy, phase 3 studies evaluating the efficacy and safety of vonoprazan-based bismuth-containing quadruple therapy for H. pylori eradication. 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 (duodenal ulcers) or 8 weeks (gastric ulcers). H. pylori-positive patients received vonoprazan- or lansoprazole-based bismuth-containing quadruple therapy for the first 2 weeks. H. pylori eradication was determined using the carbon-13 urea breath test at a follow-up visit 4 weeks post-treatment. 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 rates were 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 H. pylori-positive patients at baseline in the vonoprazan vs. lansoprazole arm. H. pylori eradication with vonoprazan-based quadruple therapy was noninferior 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). |
