The Effect of Tegoprazan on the Treatment of Endoscopic Resection-Induced Artificial Ulcers: A Multicenter, Randomized, Active-Controlled Study

Gut Liver. 2024 Mar 15;18(2):257-264. doi: 10.5009/gnl230242. Epub 2024 Feb 22.

Abstract

Background/aims: : Tegoprazan is a novel potassium-competitive acid blocker that has beneficial effects on acid-related disorders such as gastroesophageal reflux and peptic ulcer diseases. This study aimed to validate the effect of tegoprazan on endoscopic submucosal dissection (ESD)-induced artificial ulcers.

Methods: : Patients from 16 centers in Korea who underwent ESD for gastric neoplasia were enrolled. After ESD, pantoprazole was administered intravenously for 48 hours. The patients were randomly allocated to either the tegoprazan or esomeprazole group. Tegoprazan 50 mg or esomeprazole 40 mg were administered for 4 weeks, after which gastroscopic evaluation was performed. If the artificial ulcer had not healed, the same dose of tegoprazan or esomeprazole was administered for an additional 4 weeks, and a gastroscopic evaluation was performed.

Results: : One hundred sixty patients were enrolled in this study. The healing rates of artificial ulcers at 4 weeks were 30.3% (23/76) and 22.1% (15/68) in the tegoprazan and esomeprazole groups, respectively (p=0.006). At 8 weeks after ESD, the cumulative ulcer healing rates were 73.7% (56/76) and 77.9% (53/68) in the tegoprazan and esomeprazole groups, respectively (p=0.210). Delayed bleeding occurred in two patients in the tegoprazan group (2.6%) and in one patient in the esomeprazole group (1.5%). Other adverse events were negligible in both groups.

Conclusions: : Tegoprazan showed similar effects on post-ESD artificial ulcer healing in comparison with esomeprazole.

Keywords: Endoscopic resection; Endoscopic submucosal dissection; Gastric neoplasia; Multicenter prospective randomized study; Tegoprazan.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study

MeSH terms

  • Benzene Derivatives*
  • Endoscopic Mucosal Resection* / adverse effects
  • Esomeprazole / therapeutic use
  • Humans
  • Imidazoles*
  • Proton Pump Inhibitors / therapeutic use
  • Stomach Neoplasms* / etiology
  • Stomach Ulcer* / drug therapy
  • Stomach Ulcer* / etiology
  • Stomach Ulcer* / surgery
  • Ulcer / drug therapy
  • Ulcer / etiology

Substances

  • Esomeprazole
  • Proton Pump Inhibitors
  • tegoprazan
  • Benzene Derivatives
  • Imidazoles

Grants and funding

ACKNOWLEDGEMENTS This study was supported by HK Inno.N Corp. HK Inno.N provided financial support and study drug.