Preventive effect of rebamipide on NSAID-induced lower gastrointestinal tract injury using FAERS and JADER

• Published in: Scientific reports Vol. 12; no. 1; p. 2631
• Main Authors: Imai, Toru, Hazama, Katsuyuki, Kosuge, Yasuhiro, Suzuki, Shinichiro, Ootsuka, Susumu
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 16.02.2022; Nature Publishing Group; Nature Portfolio
• Subjects: 692/308/575; 692/4020/2741/520; Adverse Drug Reaction Reporting Systems; Adverse events; Alanine - administration & dosage; Alanine - analogs & derivatives; Alanine - therapeutic use; Analgesics; Anti-inflammatory agents; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Clinical trials; Databases, Factual; Diclofenac; Diclofenac - administration & dosage; Diclofenac - therapeutic use; Drug Therapy, Combination; Gastrointestinal Diseases - chemically induced; Gastrointestinal Diseases - prevention & control; Gastrointestinal Tract; Humanities and Social Sciences; Humans; Inflammation; Japan; multidisciplinary; Nonsteroidal anti-inflammatory drugs; Phenylpropionates - administration & dosage; Phenylpropionates - therapeutic use; Prophylaxis; Quinolones - administration & dosage; Quinolones - therapeutic use; Science; Science (multidisciplinary); United States; United States Food and Drug Administration; United States; Japan
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-022-06611-y

Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for their antipyretic, analgesic, and anti-inflammatory properties. However, various aspects of NSAID-induced lower gastrointestinal tract injury remain unclear, and effective prophylaxis has not been established. Based on its pharmacological effect and clinical trials, rebamipide may prevent lower gastrointestinal tract injury, although this evidence is limited by the small scale of trials. The present study used the FDA Adverse Event Reporting System (FAERS) and the Japanese Adverse Event Reporting Database (JADER) to assess the efficacy of rebamipide in combination with loxoprofen and diclofenac in preventing NSAID-induced lower gastrointestinal tract injury. The calculated reporting odds ratio and 95% confidence interval (CI) for rebamipide in combination with loxoprofen and diclofenac were 1.15 (95% CI 0.88–1.51) and 1.28 (95% CI 0.82–2.01) for FAERS, and 0.50 (95% CI 0.35–0.71) and 0.43 (95% CI 0.27–0.67) for JADER, respectively. No signal was detected when combining drugs. These results suggest a prophylactic effect of rebamipide on NSAID-induced lower gastrointestinal tract injury.