Prevention of NSAID-Associated Gastroduodenal Injury in Healthy Volunteers-A Randomized, Double-Blind, Multicenter Study Comparing DA-9601 with Misoprostolopen access
- Authors
- Lee, Kang Nyeong; Lee, Oh Young; Choi, Myung-Gyu; Choi, Seok Reyol; Lee, Dong Ho; Lee, Yong Chan; Kim, Tae Nyeun; Choi, Suck Chei; Rew, Jong Sun; Seol, Sang-Yong
- Issue Date
- Aug-2011
- Publisher
- KOREAN ACAD MEDICAL SCIENCES
- Keywords
- DA-9601; Misoprostol; NSAID-associated; Gastroduodenal Injury
- Citation
- JOURNAL OF KOREAN MEDICAL SCIENCE, v.26, no.8, pp.1074 - 1080
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- JOURNAL OF KOREAN MEDICAL SCIENCE
- Volume
- 26
- Number
- 8
- Start Page
- 1074
- End Page
- 1080
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/167839
- DOI
- 10.3346/jkms.2011.26.8.1074
- ISSN
- 1011-8934
- 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.
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