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Randomized Controlled Trial
. 2024 Oct 1;15(10):e1.
doi: 10.14309/ctg.0000000000000699.

Comparison of the Efficacy Between the Dual Therapy of Tegoprazan and the Quadruple Therapy of Tegoprazan: A Randomized Controlled Multicenter Study

Han-Ning Liu  1 , Rui Wang  2 , Yan Cao  1 , Feng Xian  2 , Xian-Jin Bi  2 , Ding-Jian Wu  2 , Bin Wang  1 , Xing-Wei Wang  1 , Chun-Hui Lan  1
Affiliations
Randomized Controlled Trial

Comparison of the Efficacy Between the Dual Therapy of Tegoprazan and the Quadruple Therapy of Tegoprazan: A Randomized Controlled Multicenter Study

Han-Ning Liu et al. Clin Transl Gastroenterol. .

Abstract

Introduction: Tegoprazan (TPZ), a potassium-competitive acid blocker, exerts a strong acid-suppression effect and a rapid onset of action. However, research on TPZ-amoxicillin (TA) dual treatment is limited. Here, we compared the safety and efficacy of TPZ-amoxicillin dual treatment and TPZ, bismuth potassium citrate, amoxicillin, and clarithromycin (TBAC) quadruple therapy in patients newly diagnosed with H. pylori infection over a 14-day treatment period.

Methods: A total of 236 patients newly diagnosed with H. pylori were enrolled in this multicenter, prospective, open-label, and randomized controlled study. Patients randomly received either TA dual or TBAC quadruple therapy. The incidence of adverse reactions and treatment compliance were recorded and then analyzed.

Results: The intention-to-treat analysis revealed that H. pylori eradication rates were 83.9% (95% confidence interval 78.2%-91.3%) and 81.4% (95% confidence interval 74.2%-88.5%) for the TA and TBAC groups, respectively, with no statistically significant difference between them ( P = 0.606). The per-protocol analysis revealed that the H. pylori eradication rates were 88.3% and 84.8% for the TA and TBAC groups, respectively ( P = 0.447). The incidence of adverse reactions was significantly lower in the TA group than in the TBAC group (4.2% vs 15.3%, P = 0.004). Moreover, the TA group demonstrated substantially higher treatment compliance than the TBAC group (94.1% vs 89.0%, P = 0.020).

Discussion: The TA dual therapy successfully eradicated H. pylori with a high eradication rate and a low incidence of adverse reactions. Therefore, this treatment is recommended as an alternative course for patients newly diagnosed with H. pylori infection.

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Conflict of interest statement

CONFLICT OF INTEREST STATEMENT

Figures

Figure 1.
Figure 1.
Flowchart depicting the subject shortlisting and classification.TA, tegoprazan-amoxicillin; TBAC, tegoprazan, bismuth potassium citrate, amoxicillin, and clarithromycin.
See this image and copyright information in PMC

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