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

Research output: Contribution to journalArticle

13 Citations (Scopus)

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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Misoprostol
Double-Blind Method
Multicenter Studies
Healthy Volunteers
Anti-Inflammatory Agents
Wounds and Injuries
Pharmaceutical Preparations
Prostaglandin-Endoperoxide Synthases
Gastric Mucosa
DA 9601
Endoscopy
Reactive Oxygen Species
Stomach
Therapeutics
Antioxidants
Safety

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

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. / Prevention of NSAID-associated gastroduodenal injury in healthy volunteers-A randomized, double-blind, multicenter study comparing DA-9601 with misoprostol. In: Journal of Korean medical science. 2011 ; Vol. 26, No. 8. pp. 1074-1080.
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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.",
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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 journalArticle

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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

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AU - Rew, Jong Sun

AU - Seol, Sang Yong

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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.

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