Tegoprazan-based versus esomeprazole-based triple therapy plus bismuth for first-line Helicobacter pylori eradication: A nationwide, multicenter, double-blind, double-dummy, randomized controlled trial.
Zhiqiang Song, Weihong Wang, Peng Li, Xiuli Zuo, Yin Zhu, Ye Chen, Xiaolan Zhang, Bin Lyu, Rong Lin, Yiqi Du, Cheng Lan, Hao Wu, Weixing Chen, Yanqing Ye, Huizhen Fan, Aijun Liao, Honghui Chen, Chengxia Liu, Zhenyu Zhang, Wen Wang, Zhimin Suo, Xiaoan Li, Qin Du, Xing Li, Feng Pan, Jianhua Tang, Min Xu, Xiongxiang Liu, Pengyuan Zheng, Huixin Chen, Ling Du, Jiayin Lu, Chun Feng, Wensheng Pan, Hong Wang, Zhirong Zeng, Jinhai Wang, Shengxiang Lyu, Dunju Liu, Shiming Yang, Liangping Li, Liya Zhou
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引用次数: 0
Abstract
Background: Although triple therapy plus bismuth (TTPB), comprising a proton pump inhibitor (PPI), two antibiotics, and bismuth, is widely used to eradicate Helicobacter pylori (H. pylori), eradication rates have been suboptimal. Potassium-competitive acid blockers (P-CABs) offer stronger and more stable gastric acid inhibition compared to PPIs. This study aimed to compare the efficacy, safety, and compliance of tegoprazan-based TTPB (TACB) vs. esomeprazole-based TTPB (EACB) in treatment-naïve patients with H. pylori infection.
Methods: In this nationwide, multicenter, double-blind, double-dummy, randomized controlled trial conducted from October 2022 to September 2023 across 41 centers in China, 561 eligible patients with H. pylori infection were randomized (1:1) to receive either TACB (tegoprazan 50 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth 220 mg) or EACB (esomeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth 220 mg), all administered twice daily for 14 days. H. pylori eradication was assessed using the 13C-urea breath test at 4-8 weeks post-treatment. The primary endpoint was eradication rate based on the full analysis set (FAS). Statistical analysis included the chi-squared tests, with a predefined non-inferiority margin of -10%.
Results: In the FAS population, eradication rates were 93.5% (95% confidence interval [CI]: 89.9-96.1%) in the TACB group and 86.4% (95% CI: 81.9-90.2%) in the EACB group. The between-group difference was 7.0% (95% CI: 2.1-12.0%), indicating that tegoprazan-based TTPB was non-inferior to esomeprazole-based TTPB. Furthermore, superiority tests found a significantly higher eradication rate in tegoprazan group compared with esomeprazole group (P = 0.006). Similar results were observed in the per-protocol set. The incidence of treatment-emergent adverse events was comparable between groups (75.5% in TACB vs. 73.4% in EACB), with most events being mild and transient. Compliance was high in both groups (98.4% vs. 98.8%).
Conclusion: TACB was non-inferior to EACB in H. pylori eradication efficacy, with similar safety and compliance profiles in Chinese treatment-naïve patients.
期刊介绍：
The Chinese Medical Journal (CMJ) is published semimonthly in English by the Chinese Medical Association, and is a peer reviewed general medical journal for all doctors, researchers, and health workers regardless of their medical specialty or type of employment. Established in 1887, it is the oldest medical periodical in China and is distributed worldwide. The journal functions as a window into China’s medical sciences and reflects the advances and progress in China’s medical sciences and technology. It serves the objective of international academic exchange. The journal includes Original Articles, Editorial, Review Articles, Medical Progress, Brief Reports, Case Reports, Viewpoint, Clinical Exchange, Letter,and News,etc. CMJ is abstracted or indexed in many databases including Biological Abstracts, Chemical Abstracts, Index Medicus/Medline, Science Citation Index (SCI), Current Contents, Cancerlit, Health Plan & Administration, Embase, Social Scisearch, Aidsline, Toxline, Biocommercial Abstracts, Arts and Humanities Search, Nuclear Science Abstracts, Water Resources Abstracts, Cab Abstracts, Occupation Safety & Health, etc. In 2007, the impact factor of the journal by SCI is 0.636, and the total citation is 2315.
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