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

Yoon Jin Choi, Yong Chan Lee, Jung Mogg Kim, Jin Il Kim, Jeong Seop Moon, Yun Jeong Lim, Gwang Ho Baik, Byoung Kwan Son, Hang Lak Lee, Kyoung Oh Kim, Nayoung Kim, Kwang Hyun Ko, Hye Kyung Jung, Ki Nam Shim, Hoon Jai Chun, Byung Wook Kim, Hyuk Lee, Jie Hyun Kim, Hyunsoo Chung, Sang Gyun KimJae Young Jang

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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.

Original languageEnglish
Pages (from-to)533-546
Number of pages14
JournalGut and Liver
Volume16
Issue number4
DOIs
StatePublished - Jul 2022

Keywords

  • Helicobacter pylori
  • Potassium-competitive acid blocker
  • Tegoprazan

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