Prevention of NSAID-associated gastroduodenal injury in healthy volunteers-a randomized, double-blind, multicenter study comparing DA-9601 with misoprostol

• Published in: Journal of Korean medical science 2011, 26(8), 154, pp.1074-1080
• Main 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
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Double-Blind Method; Duodenal Ulcer - chemically induced; Duodenal Ulcer - prevention & control; Endoscopy, Gastrointestinal; Female; Gastric Mucosa - drug effects; Humans; Male; Middle Aged; Misoprostol - adverse effects; Original; Plant Extracts - adverse effects; Stomach Ulcer - chemically induced; Stomach Ulcer - prevention & control; 의학일반
• ISSN: 1011-8934; 1598-6357
• DOI: 10.3346/jkms.2011.26.8.1074

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 µg 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.