Prevention of NSAID-Associated Gastroduodenal Injury in Healthy Volunteers-A Randomized, Double-Blind, Multicenter Study Comparing DA-9601 with Misoprostol

Title
Prevention of NSAID-Associated Gastroduodenal Injury in Healthy Volunteers-A Randomized, Double-Blind, Multicenter Study Comparing DA-9601 with Misoprostol
Author(s)
김태년이강녕[이강녕]이오영[이오영]최명규[최명규]최석렬[최석렬]이동호[이동호]이용찬[이용찬]최석채[최석채]류종선[류종선]설상용[설상용]
Keywords
NONSTEROIDAL ANTIINFLAMMATORY DRUGS; GASTRIC EPITHELIAL-CELLS; LONG-TERM USERS; ARTEMISIA-ASIATICA; GASTROINTESTINAL COMPLICATIONS; OXIDATIVE STRESS; ULCER PREVENTION; EXTRACT; RATS; DAMAGE
Issue Date
201108
Publisher
KOREAN ACAD MEDICAL SCIENCES
Citation
JOURNAL OF KOREAN MEDICAL SCIENCE, v.26, no.8, pp.1074 - 1080
Abstract
In addition to inhibiting cyclooxygenase and prostaglandin, nonsteroidal anti-inflammatory drugs (NSAIDs) may cause gastroduodenal injuries due to reactive oxygen species produced by recruited inflammatory cells. DA-9601 is a novel antioxidant with anti-inflammatory and cyto-protective effects. This study was conducted to compare the efficacy and safety of DA-9601 with misoprostol for preventing NSAID-associated gastroduodenal injury. In this randomized, double-blind, multicenter, noninferiority trial we compared the extents of protection of gastric and duodenal mucosae by endoscopy after 4 weeks of treatment with DA-9601 60 mg or misoprostol 200 mu g three times daily, in subjects with normal baseline endoscopic findings who received an NSAID twice daily for 4 weeks. A total of 266 subjects were randomized to treatment. At week 4, the gastric protection rates with DA-9601 and misoprostol were 85.1% and 95.2%, respectively; the difference between the groups was -10.1% (var = 0.001), which was shown to indicate noninferiority of DA-9601 compared to misoprostol. Adverse events were lower in the DA-9601 group, 56.4% (95% CI, 48.0%-64.8%) than in the misoprostol group, 69.2% (95% CI, 61.3%-77.0%) (P = 0.031). DA-9601 is not inferior to misoprostol for preventing NSAID-associated gastroduodenal injury, and superior to it with respect to treatment-related side effects.
URI
http://hdl.handle.net/YU.REPOSITORY/24799http://dx.doi.org/10.3346/jkms.2011.26.8.1074
ISSN
1011-8934
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의과대학 > 내과학교실 > Articles
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