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 language | English |
|---|---|
| Pages (from-to) | 1074-1080 |
| Number of pages | 7 |
| Journal | Journal of Korean medical science |
| Volume | 26 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - 2011 Aug 1 |
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All Science Journal Classification (ASJC) codes
- Medicine(all)
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Prevention of NSAID-associated gastroduodenal injury in healthy volunteers-A randomized, double-blind, multicenter study comparing DA-9601 with misoprostol. / 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.
In: Journal of Korean medical science, Vol. 26, No. 8, 01.08.2011, p. 1074-1080.Research output: Contribution to journal › Article
TY - JOUR
T1 - Prevention of NSAID-associated gastroduodenal injury in healthy volunteers-A randomized, double-blind, multicenter study comparing DA-9601 with misoprostol
AU - Lee, Kang Nyeong
AU - Lee, Oh Young
AU - Choi, Myung Gyu
AU - Choi, Seok Reyol
AU - Lee, Dong Ho
AU - Lee, Yong Chan
AU - Kim, Tae Nyeun
AU - Choi, Suck Chei
AU - Rew, Jong Sun
AU - Seol, Sang Yong
PY - 2011/8/1
Y1 - 2011/8/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=80052652803&partnerID=8YFLogxK
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U2 - 10.3346/jkms.2011.26.8.1074
DO - 10.3346/jkms.2011.26.8.1074
M3 - Article
C2 - 21860559
AN - SCOPUS:80052652803
VL - 26
SP - 1074
EP - 1080
JO - Journal of Korean Medical Science
JF - Journal of Korean Medical Science
SN - 1011-8934
IS - 8
ER -