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

• Published in: Biological & pharmaceutical bulletin 2024/08/01, Vol.47(8), pp.1405-1414
• Main Authors: Hou, Xiaohua, Wang, Jiangbin, Du, Qin, Tian, Dean, Hu, Naizhong, Liu, Deliang, Zhou, Fang, Xie, Li, Gu, Liqun, Kudou, Kentarou, Zhang, Shutian
• Format: Article
• Language: English
• Subjects: Adult; Aged; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - therapeutic use; Anti-Ulcer Agents - administration & dosage; Anti-Ulcer Agents - adverse effects; Anti-Ulcer Agents - therapeutic use; bismuth-containing quadruple therapy; Breath Tests; Carbon 13; Clinical trials; Double-Blind Method; Drug Therapy, Combination; Eradication; Female; Helicobacter Infections - drug therapy; Helicobacter Infections - microbiology; Helicobacter pylori; Helicobacter pylori - drug effects; Humans; lansoprazole; Lansoprazole - administration & dosage; Lansoprazole - adverse effects; Lansoprazole - therapeutic use; Male; Middle Aged; peptic ulcer; Peptic Ulcer - drug therapy; Peptic Ulcer - microbiology; Peptic ulcers; Proton Pump Inhibitors - administration & dosage; Proton Pump Inhibitors - adverse effects; Proton Pump Inhibitors - therapeutic use; Pyrroles - administration & dosage; Pyrroles - adverse effects; Pyrroles - therapeutic use; Sulfonamides - administration & dosage; Sulfonamides - adverse effects; Sulfonamides - therapeutic use; Treatment Outcome; Ulcers; vonoprazan
• ISSN: 0918-6158; 1347-5215; 1347-5215
• DOI: 10.1248/bpb.b24-00011

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