Korean J Intern Med.  2019 Sep;34(5):1008-1021. 10.3904/kjim.2017.370.

The efficacy and safety of irsogladine maleate in nonsteroidal anti-inflammatory drug or aspirin-induced peptic ulcer and gastritis

Affiliations
  • 1Department of Internal Medicine, College of Medicine, Ewha Womans University, Ewha Medical Research Institute, Seoul, Korea.
  • 2Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  • 3Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. nayoungkim49@empas.com
  • 4Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.
  • 5Department of Internal Medicine, Eulji University School of Medicine, Seoul, Korea.
  • 6Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea.
  • 7Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea.
  • 8Department of Internal Medicine, Pusan National University School of Medicine, and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea.
  • 9Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
  • 10Department of Internal Medicine, Wonkwang University College of Medicine and Digestive Disease Research Institute, Iksan, Korea.
  • 11Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea.
  • 12Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
  • 13Department of Internal Medicine, Gyeongsang National University School of Medicine, Jinju, Korea.
  • 14Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, Korea.

Abstract

BACKGROUND/AIMS
Irsogladine maleate, an enhancer of gastric mucosal protective factors, has demonstrated its efficacy for various gastric mucosal injuries. The aim of this study was to evaluate the efficacy and safety of irsogladine for prevention of nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin-induced peptic ulcer and gastritis.
METHODS
In this multicenter, randomized, double-blind, exploratory clinical trial, 100 patients over 50 years of age who needed continuous NSAIDs or aspirin for more than 8 weeks were randomly assigned to either test group (irsogladine maleate 2 mg, twice daily, 39 patients for full analysis) or placebo group (37 patients for full analysis). Primary outcomes were incidence of peptic ulcer and ratio of modified Lanza score (MLS) 2 to 4. Secondary outcome was the number of acute erosions confirmed by endoscopy at 8 weeks. Adverse effects were also compared.
RESULTS
There were no significant differences in gastric protective effects between test and placebo groups. However, two cases of peptic ulcer in the placebo group but none in the test group were observed. These two cases of peptic ulcer were Helicobacter pylori-negative. In addition, H. pylori-negative group showed significant changes in MLS score (p = 0.0247) and edema score (p = 0.0154) after the treatment compared to those before treatment in the test group. There was no significant difference in adverse events between the two groups.
CONCLUSIONS
The efficacy of irsogladine maleate was found in H. pylori-negative group, suggesting its potential as a protective agent against NSAIDs or aspirin-induced peptic ulcer and gastritis.

Keyword

Irsogladine maleate; Anti-inflammatory agents, non-steroidal; Aspirin; Peptic ulcer; Gastritis
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