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Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Helicobacter pylori Infection: A Randomized, Double-Blind, Phase III, Clinical Trial
- Title
- Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Helicobacter pylori Infection: A Randomized, Double-Blind, Phase III, Clinical Trial
- Authors
- Choi Y.J.; Lee Y.C.; Kim J.M.; Kim J.I.; Moon J.S.; Lim Y.J.; Baik G.H.; Son B.K.; Lee H.L.; Kim K.O.; Kim N.; Ko K.H.; Jung H.-K.; Shim K.-N.; Chun H.J.; Kim B.-W.; Lee H.; Kim J.-H.; Chung H.; Kim S.G.; Jang J.Y.
- Ewha Authors
- 정혜경; 심기남
- SCOPUS Author ID
- 정혜경; 심기남
- Issue Date
- 2022
- Journal Title
- Gut and Liver
- ISSN
- 1976-2283
- Citation
- Gut and Liver vol. 16, no. 4, pp. 533 - 546
- Keywords
- Helicobacter pylori; Potassium-competitive acid blocker; Tegoprazan
- Publisher
- Editorial Office of Gut and Liver
- Indexed
- SCIE; SCOPUS; KCI
- Document Type
- Article
- Abstract
- Background/Aims: We examined the efficacy and safety of tegoprazan as a part of first-line triple therapy for Helicobacter pylori eradication. Methods: A randomized, double-blind, controlled, multicenter study was performed to evaluate whether tegoprazan (50 mg)-based triple therapy (TPZ) was noninferior to lansoprazole (30 mg)- based triple therapy (LPZ) (with amoxicillin 1 g and clarithromycin 500 mg; all administered twice daily for 7 days) for treating H. pylori. The primary endpoint was the H. pylori eradication rate. Subgroup analyses were performed according to the cytochrome P450 (CYP) 2C19 genotype, the minimum inhibitory concentration (MIC) of amoxicillin and clarithromycin, and underlying gastric diseases. Results: In total, 350 H. pylori-positive patients were randomly allocated to the TPZ or LPZ group. The H. pylori eradication rates in the TPZ and LPZ groups were 62.86% (110/175) and 60.57% (106/175) in an intention-to-treat analysis and 69.33% (104/150) and 67.33% (101/150) in a per-protocol analysis (non-inferiority test, p=0.009 and p=0.013), respectively. Subgroup analyses according to MICs or CYP2C19 did not show remarkable differences in eradication rate. Both first-line triple therapies were well-tolerated with no notable differences. Conclusions: TPZ is as effective as proton pump inhibitor-based triple therapy and is as safe as first-line H. pylori eradication therapy but does not overcome the clarithromycin resistance of H. pylori in Korea. © 2022 Editorial Office of Gut and Liver. All rights reserved.
- DOI
- 10.5009/gnl220055
- Appears in Collections:
- 의과대학 > 의학과 > Journal papers
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