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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

Authors
Choi, Yoon JinLee, Yong ChanKim, Jung MoggKim, Jin IlMoon, Jeong SeopLim, Yun JeongBaik, Gwang HoSon, Byoung KwanLee, Hang LakKim, Kyoung OhKim, NayoungKo, Kwang HyunJung, Hye-KyungShim, Ki -NamChun, Hoon JaiKim, Byung-WookLee, HyukKim, Jie-HyunChung, HyunsooKim, Sang GyunJang, Jae Young
Issue Date
Jul-2022
Publisher
거트앤리버 발행위원회
Keywords
Helicobacter pylori; Potassium-competitive acid blocker; Tegoprazan
Citation
Gut and Liver, v.16, no.4, pp.535 - 546
Indexed
SCIE
SCOPUS
KCI
Journal Title
Gut and Liver
Volume
16
Number
4
Start Page
535
End Page
546
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/61270
DOI
10.5009/gnl220055
ISSN
1976-2283
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 (ClinicalTrials.gov identifier NCT03317223).
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Chun, Hoon Jai
Anam Hospital (Department of Gastroenterology and Hepatology, Anam Hospital)
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