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The Efficacy and Safety of Irsogladine Maleate in Nonsteroidal Anti-Inflammatory Drug or Aspirin-Induced Peptic Ulcer and Gastritis

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Author(s)
Ki-Nam ShimJin Il KimNayoung KimSang Gyun KimYun Ju JoSu Jin HongJeong Eun ShinGwang Ha KimKyung Sik ParkSuck Chei ChoiJoong Goo KwonJie-Hyun KimHyun Jin KimJi Won Kim
Keimyung Author(s)
Park, Kyung Sik
Department
Dept. of Internal Medicine (내과학)
Journal Title
Korean journal of internal medicine
Issued Date
2019
Volume
34
Issue
5
Keyword
Irsogladine maleateAnti-inflammatory agents, non-steroidalAspirinPeptic ulcerGastritis
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.
Keimyung Author(s)(Kor)
박경식
Publisher
School of Medicine (의과대학)
Citation
Ki-Nam Shim et al. (2019). The Efficacy and Safety of Irsogladine Maleate in Nonsteroidal Anti-Inflammatory Drug or Aspirin-Induced Peptic Ulcer and Gastritis. Korean journal of internal medicine, 34(5), 1008–1021. doi: 10.3904/kjim.2017.370
Type
Article
ISSN
2005-6648
Source
http://kjim.org/journal/view.php?doi=10.3904/kjim.2017.370
DOI
10.3904/kjim.2017.370
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/42383
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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