Prevention of NSAID-Associated Gastroduodenal Injury in Healthy Volunteers-A Randomized, Double-Blind, Multicenter Study Comparing DA-9601 with Misoprostol.
10.3346/jkms.2011.26.8.1074
- Author:
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
Author Information
1. Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
- Publication Type:Original Article ; Comparative Study ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
- Keywords:
DA-9601;
Misoprostol;
NSAID-associated;
Gastroduodenal Injury
- MeSH:
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
- From:Journal of Korean Medical Science
2011;26(8):1074-1080
- CountryRepublic of Korea
- Language:English
-
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.
