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

• Published in: The Korean journal of internal medicine Vol. 34; no. 5; pp. 1008 - 1021
• Main Authors: Shim, Ki-Nam, Kim, Jin Il, Kim, Nayoung, Kim, Sang Gyun, Jo, Yun Ju, Hong, Su Jin, Shin, Jeong Eun, Kim, Gwang Ha, Park, Kyung Sik, Choi, Suck Chei, Kwon, Joong Goo, Kim, Jie-Hyun, Kim, Hyun Jin, Kim, Ji Won
• Format: Journal Article
• Language: English
• Published: Korea (South) The Korean Association of Internal Medicine 01.09.2019; 대한내과학회
• Subjects: Aged; Aged, 80 and over; anti-inflammatory agents, non-steroidal; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Ulcer Agents - adverse effects; Anti-Ulcer Agents - therapeutic use; aspirin; Double-Blind Method; Female; Gastric Mucosa - drug effects; Gastric Mucosa - pathology; gastritis; Gastritis - chemically induced; Gastritis - diagnosis; Gastritis - prevention & control; Humans; irsogladine maleate; Male; Middle Aged; Original; peptic ulcer; Republic of Korea; Risk Factors; Stomach Ulcer - chemically induced; Stomach Ulcer - diagnosis; Stomach Ulcer - prevention & control; Time Factors; Treatment Outcome; Triazines - adverse effects; Triazines - therapeutic use; 내과학; Republic of Korea; Peptic ulcer; Aspirin; Irsogladine maleate; Anti-inflammatory agents, non-steroidal; Gastritis
• ISSN: 1226-3303; 2005-6648; 2005-6648
• DOI: 10.3904/kjim.2017.370

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. 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. 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. 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.