title: Prevention of NSAID-associated gastroduodenal injury in healthy volunteers-a randomized, double-blind, multicenter study comparing DA-9601 with misoprostol.
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 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.
authors.affiliation: Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
authors.forename: Kang Nyeong
authors.initials: KN
authors.lastname: Lee
authors.forename: Oh Young
authors.initials: OY
authors.lastname: Lee
authors.forename: Myung-Gyu
authors.initials: MG
authors.lastname: Choi
authors.forename: Seok Reyol
authors.initials: SR
authors.lastname: Choi
authors.forename: Dong Ho
authors.initials: DH
authors.lastname: Lee
authors.forename: Yong Chan
authors.initials: YC
authors.lastname: Lee
authors.forename: Tae Nyeun
authors.initials: TN
authors.lastname: Kim
authors.forename: Suck Chei
authors.initials: SC
authors.lastname: Choi
authors.forename: Jong Sun
authors.initials: JS
authors.lastname: Rew
authors.forename: Sang-Yong
authors.initials: SY
authors.lastname: Seol
mesh_terms: D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000139:chemically induced / Q000517:prevention & control*; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D016595:Misoprostol / Q000009:adverse effects*; D010936:Plant Extracts / Q000009:adverse effects*; D013276:Stomach Ulcer / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; C116959:DA 9601; D010936:Plant Extracts; D016595:Misoprostol