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

Kang Nyeong Lee, Oh Young Lee, Myung Gyu Choi, Seok Reyol Choi, Dong Ho Lee, Yong Chan Lee, Tae Nyeun Kim, Suck Chei Choi, Jong Sun Rew, Sang Yong Seol

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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.

Original languageEnglish
Pages (from-to)1074-1080
Number of pages7
JournalJournal of Korean medical science
Volume26
Issue number8
DOIs
Publication statusPublished - 2011 Aug 1

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All Science Journal Classification (ASJC) codes

  • Medicine(all)

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