Vonoprazan-based quadruple therapy is non-inferior to esomeprazole-based quadruple therapy for Helicobacter pylori eradication: A multicenter, double-blind, randomized, phase 3 study.
10.1097/CM9.0000000000003437
- Author:
Zhiqiang SONG
1
;
Qin DU
2
;
Guoxin ZHANG
3
;
Zhenyu ZHANG
4
;
Fei LIU
5
;
Nonghua LU
6
;
Liqun GU
7
;
Shingo KURODA
8
;
Liya ZHOU
1
Author Information
1. Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China.
2. Department of Gastroenterology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang 310000, China.
3. Department of Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210000, China.
4. Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210000, China.
5. Department of Gastroenterology, Shanghai East Hospital Affiliated Tongji University, Shanghai 200000, China.
6. Department of Gastroenterology, First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330000, China.
7. Takeda Development Center Asia, Shanghai 200000, China.
8. Takeda Pharmaceutical Company Limited, Osaka 034-0041, Japan.
- Publication Type:Clinical Trial, Phase III
- Keywords:
China;
Esomeprazole;
Phase 3;
Vonoprazan;
quadruple therapy
- MeSH:
Humans;
Esomeprazole/therapeutic use*;
Double-Blind Method;
Helicobacter Infections/drug therapy*;
Male;
Female;
Middle Aged;
Helicobacter pylori/pathogenicity*;
Pyrroles/therapeutic use*;
Sulfonamides/therapeutic use*;
Adult;
Clarithromycin/therapeutic use*;
Amoxicillin/therapeutic use*;
Aged;
Anti-Bacterial Agents/therapeutic use*;
Pyrrolidines/therapeutic use*;
Drug Therapy, Combination;
Proton Pump Inhibitors/therapeutic use*
- From:
Chinese Medical Journal
2025;138(22):2938-2946
- CountryChina
- Language:English
-
Abstract:
BACKGROUND:Owing to the high prevalence of antibiotic resistance in Helicobacter pylori ( H. pylori ) in China, bismuth-containing quadruple therapies have been recommended for H. pylori eradication. This study compared the efficacy and safety of quadruple regimens containing vonoprazan vs . esomeprazole for H. pylori eradication in a patient population in China.
METHODS:This was a phase 3, multicenter, randomized, double-blind study. Patients with confirmed H. pylori infection were randomized 1:1 to receive quadruple therapy for 14 days: amoxicillin 1000 mg and clarithromycin 500 mg after meals, bismuth potassium citrate 600 mg before meals, plus either vonoprazan 20 mg or esomeprazole 20 mg before meals, all twice daily. The primary outcome was the eradication rate of H. pylori , evaluated using a 13 C urea breath test at 4 weeks after treatment. The non-inferiority margin was at 10%.
RESULTS:The study included 510 patients, 506 of whom completed the follow-up assessment. The primary analysis revealed eradication rates of 86.8% (210/242) and 86.7% (208/240) for vonoprazan and esomeprazole therapy, respectively (treatment difference: 0.1%; 95% confidence interval [CI]: -5.95, 6.17; non-inferiority P = 0.0009). Per-protocol analysis showed eradication rates of 87.4% for vonoprazan and 86.3% for esomeprazole (treatment difference: 1.2%; 95% CI: -5.03, 7.36; non-inferiority P = 0.0004). Vonoprazan and esomeprazole were well tolerated, with similar safety profiles.
CONCLUSION:Vonoprazan was found to be well-tolerated and non-inferior to esomeprazole for eradicating H. pylori in patients from China.
TRIAL REGISTRATION:ClinicalTrials.gov , NCT04198363.
