J Korean Med Sci.  2011 Aug;26(8):1074-1080. 10.3346/jkms.2011.26.8.1074.

Prevention of NSAID-Associated Gastroduodenal Injury in Healthy Volunteers-A Randomized, Double-Blind, Multicenter Study Comparing DA-9601 with Misoprostol

• Lee KN
• Lee OY
• Choi MG
• Choi SR
• Lee DH
• Lee YC
• Kim TN
• Choi SC
• Rew JS
• Seol SY

• KMID: 1777847
• DOI: http://doi.org/10.3346/jkms.2011.26.8.1074

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 microg 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.

Keyword

DA-9601; Misoprostol; NSAID-associated; Gastroduodenal Injury

MeSH Terms

Adolescent
Adult
Anti-Inflammatory Agents, Non-Steroidal/*adverse effects
Double-Blind Method
Duodenal Ulcer/chemically induced/*prevention & control
Endoscopy, Gastrointestinal
Female
Gastric Mucosa/drug effects
Humans
Male
Middle Aged
Misoprostol/*adverse effects
Plant Extracts/*adverse effects
Stomach Ulcer/chemically induced/*prevention & control

Figure

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  Fig. 1 Patient disposition. Cumulative number of dropouts and medical reasons for withdrawal from the study.

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