Fourteen‐and Ten‐Day Tegoprazan–Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for <scp> <i>Helicobacter pylori</i> </scp> Eradication—A Noninferiority, Multicenter, Randomized Controlled Trial
Yan Fan, Chuanfei Li, Wenguang Zhang, Jinlian Shi, Renzheng Liang, Meng Deng, Shengtao Liao, Xiao Xiao, Ke Zhan, Liewang Qiu, Zhechuan Mei, Lin Lv
Abstract
BACKGROUND AND AIM: Tegoprazan has shown great potential in the eradication of Helicobacter pylori infection. This study aims to evaluate the efficacy and safety of Tegoprazan-based dual therapy for H. pylori eradication. METHODS: This was a noninferiority, multicenter, randomized controlled trial in China. Subjects were randomly assigned to three groups: the 14-THA group, the 10-THA group (Tegoprazan 50 mg twice/day, Amoxicillin 1 g 3 times/day, for 14 and 10 days), and the B-quadruple group (esomeprazole 20 mg, bismuth 220 mg, Amoxicillin 1 g, twice/day, tetracycline 0.5 g 3 times/day, for 14 days). The three groups' eradication rates, adverse events, and compliance were compared. RESULTS: A total of 228 individuals were included in the randomization. According to the per-protocol analysis (PP), modified intention-to-treat (MITT) analysis, and intention-to-treat (ITT) analysis, there was no statistically significant difference between the 14-THA group and B-quadruple group (PP: 90.3% vs. 91.8%, MITT: 84.8% vs. 90.5%, ITT: 73.7% vs. 75.0%, p > 0.05). However, the 10-THA group has a lower eradication rate than the B-quadruple group (PP: 67.2% vs. 91.8%, MITT: 64.1% vs. 90.5%, ITT: 53.9% vs. 75.0%, p < 0.05). Additionally, the efficacy of the 14-THA group was not inferior to that of the B-quadruple group in PP (p = 0.0488). Adverse events and compliance rates did not differ among the three groups (p > 0.05). CONCLUSION: The eradication rate of the 14-THA group is > 90%, which is not inferior to the current bismuth-containing quadruple regimen, with a favorable safety profile. However, the efficacy of the 10-THA dual therapy is unacceptable.