Gut Liver.  2022 Jul;16(4):535-546. 10.5009/gnl220055.

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

Affiliations
  • 1Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
  • 2Department of Microbiology and Institute of Biomedical Science, Hanyang University College of Medicine, Seoul, Korea.
  • 3Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  • 4Department of Internal Medicine, Inje University Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea.
  • 5Department of Internal Medicine, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, Goyang, Korea.
  • 6Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Korea.
  • 7Department of Internal Medicine, Uijeongbu Eulji Medical Center, Eulji University, Uijeongbu, Korea.
  • 8Department of Internal Medicine, Hanyang University Medical Center, Seoul, Korea.
  • 9Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.
  • 10Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
  • 11Department of Internal Medicine, Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, Korea.
  • 12Department of Internal Medicine, Ewha Womans University Mokdong Hospital, Seoul, Korea.
  • 13Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
  • 14Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea.
  • 15Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 16Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
  • 17Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
  • 18Department of Internal Medicine, College of Medicine, Kyung Hee University, Seoul, Korea.

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

Keyword

Helicobacter pylori; Potassium-competitive acid blocker; Tegoprazan
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