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Randomized Controlled Trial
. 2011 Aug;26(8):1074-80.
doi: 10.3346/jkms.2011.26.8.1074. Epub 2011 Jul 29.

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

Kang Nyeong Lee  1 , 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
Affiliations
Randomized Controlled Trial

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

Kang Nyeong Lee et al. J Korean Med Sci. 2011 Aug.

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.

Keywords: DA-9601; Gastroduodenal Injury; Misoprostol; NSAID-associated.

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Figures

Fig. 1
Fig. 1
Patient disposition. Cumulative number of dropouts and medical reasons for withdrawal from the study.
See this image and copyright information in PMC

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