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

Title
The efficacy and safety of irsogladine maleate in nonsteroidal anti-inflammatory drug or aspirin-induced peptic ulcer and gastritis
Authors
Shim, Ki-NamKim, Jin IlKim, NayoungKim, Sang GyunJo, Yun JuHong, Su JinShin, Jeong EunKim, Gwang HaPark, Kyung SikChoi, Suck CheiKwon, Joong GooKim, Jie-HyunKim, Hyun JinKim, Ji Won
Ewha Authors
심기남
SCOPUS Author ID
심기남scopus
Issue Date
2019
Journal Title
KOREAN JOURNAL OF INTERNAL MEDICINE
ISSN
1226-3303JCR Link

2005-6648JCR Link
Citation
KOREAN JOURNAL OF INTERNAL MEDICINE vol. 34, no. 5, pp. 1008 - +
Keywords
Irsogladine maleateAnti-inflammatory agentsnon-steroidalAspirinPeptic ulcerGastritis
Publisher
KOREAN ASSOC INTERNAL MEDICINE
Indexed
SCIE; SCOPUS; KCI WOS scopus
Document Type
Article
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, loo 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.
DOI
10.3904/kjim.2017.370
Appears in Collections:
의과대학 > 의학과 > Journal papers
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