Gut Liver.
2014 Jul;8(4):371-379.
Preventive Efficacy and Safety of Rebamipide in Nonsteroidal Anti-Inflammatory Drug-Induced Mucosal Toxicity
- Affiliations
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- 1Department of Gastroenterology, Yeouido St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea. psheon5132@naver.com
- 2Department of Rheumatology, Yeouido St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea.
- 3Department of Gastroenterology, Chonbuk National University Hospital, Chonbuk National University Medical School, Jeonju, Korea.
- 4Department of Rheumatology, Chonbuk National University Hospital, Chonbuk National University Medical School, Jeonju, Korea.
- 5Department of Gastroenterology, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea.
- 6Department of Rheumatology, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea.
- 7Department of Gastroenterology, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Korea.
- 8Department of Rheumatology, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Korea.
- 9Department of Rheumatology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
- 10Department of Gastroenterology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
- 11Department of Rheumatology, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.
- 12Department of Gastroenterology, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.
Abstract
- BACKGROUND/AIMS
The use of proton pump inhibitors or misoprostol is known to prevent the gastrointestinal complications of nonsteroidal anti-inflammatory drugs (NSAIDs). Rebamipide is known to increase the mucosal generation of prostaglandins and to eliminate free oxygen radicals, thus enhancing the protective function of the gastric mucosa. However, it is unknown whether rebamipide plays a role in preventing NSAID-induced gastropathy. The aim of this study was to determine the effectiveness of rebamipide compared to misoprostol in preventing NSAID-induced gastrointestinal complications in patients requiring continuous NSAID treatment.
METHODS
We studied 479 patients who required continuous NSAID treatment. The patients were randomly assigned to groups that received 100 mg of rebamipide three times per day or 200 microg of misoprostol three times per day for 12 weeks. The primary endpoint of the analysis was the occurrence rate of gastric ulcers, as determined by endoscopy after 12 weeks of therapy.
RESULTS
Of the 479 patients in the study, 242 received rebamipide, and 237 received misoprostol. Ultimately, 44 patients (18.6%) withdrew from the misoprostol group and 25 patients (10.3%) withdrew from the rebamipide group. There was a significant difference in withdrawal rate between the two groups (p=0.0103). The per protocol analysis set was not valid because of the dropout rate of the misoprostol group; thus, the intention to treat (ITT) analysis set is the main set for the efficacy analysis in this study. After 12 weeks, the occurrence rate of gastric ulcers was similar in the rebamipide and misoprostol groups (20.3% vs 21.9%, p=0.6497) according to ITT analysis. In addition, the therapeutic failure rate was similar in the rebamipide and misoprostol groups (13.6% vs 13.1%, p=0.8580). The total severity score of the gastrointestinal symptoms was significantly lower in the rebamipide group than in the misoprostol group (p=0.0002). The amount of antacid used was significantly lower in the rebamipide group than in the misoprostol group (p=0.0258).
CONCLUSIONS
Rebamipide can prevent gastric ulcers when used with NSAIDs and can decrease the gastrointestinal symptoms associated with NSAID administration. When the possibility of poor compliance and the potential adverse effects of misoprostol are considered, rebamipide appears to be a clinically effective and safe alternative.
Keyword
MeSH Terms
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Adult
Aged
Alanine/administration & dosage/adverse effects/*analogs & derivatives
Anti-Inflammatory Agents, Non-Steroidal/*adverse effects
Anti-Ulcer Agents/*administration & dosage/adverse effects
Arthritis/drug therapy
Butanones/adverse effects
Diclofenac/adverse effects/analogs & derivatives
Double-Blind Method
Drug Administration Schedule
Gastric Mucosa
Humans
Middle Aged
Misoprostol/*administration & dosage/adverse effects
Quinolones/*administration & dosage/adverse effects
Stomach Ulcer/chemically induced/*prevention & control
Thiazines/adverse effects
Thiazoles/adverse effects
Treatment Outcome
Alanine
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Butanones
Diclofenac
Quinolones
Thiazines
Thiazoles
Misoprostol
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