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KMID : 1188320220160040535
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Gut and Liver
2022 Volume.16 No. 4 p.535 ~ p.546
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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
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Choi Yoon-Jin
Lee Yong-Chan
Kim Jung-Mogg
Kim Jin-Il
Moon Jeong-Seop
Lim Yun-Jeong
Baik Gwang-Ho
Son Byoung-Kwan
Lee Hang-Lak
Kim Kyoung-Oh
Kim Na-Young
Ko Kwang-Hyun
Jung Hye-Kyung
Shim Ki-Nam
Chun Hoon-Jai
Kim Byung-Wook
Lee Hyuk
Kim Jie-Hyun
Chung Hyun-Soo
Kim Sang-Gyun
Jang Jae-Young
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Abstract
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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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KEYWORD
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Helicobacter pylori, Potassium-competitive acid blocker, Tegoprazan
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