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Evaluation of selective cyclooxygenase‐2 inhibitor‐induced small bowel injury: Randomized cross‐over study compared with loxoprofen in healthy subjects
Author(s) -
Mizukami Kazuhiro,
Murakami Kazunari,
Yamauchi Mika,
Matsunari Osamu,
Ogawa Ryo,
Nakagawa Yoshifumi,
Okimoto Tadayoshi,
Kodama Masaaki,
Fujioka Toshio
Publication year - 2013
Publication title -
digestive endoscopy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.5
H-Index - 56
eISSN - 1443-1661
pISSN - 0915-5635
DOI - 10.1111/j.1443-1661.2012.01379.x
Subject(s) - celecoxib , medicine , clinical endpoint , gastroenterology , cyclooxygenase , capsule endoscopy , intestinal mucosa , valdecoxib , randomized controlled trial , enzyme , biochemistry , chemistry , rofecoxib
Aim Non‐steroidal anti‐inflammatory drugs have the potential to injure the mucosa of the upper digestive tract and small bowel, whereas celecoxib (a selective cyclooxygenase‐2 inhibitor) has less influence on the entire digestive tract mucosa. The present study was conducted to compare the extents of small bowel mucosal injury induced by celecoxib and loxoprofen (the most frequently used non‐steroidal anti‐inflammatory drugs in J apan). Methods Ten healthy adult males were given celecoxib (200 mg/day, Group C ) and loxoprofen (180 mg/day, Group L ) in a cross‐over design for 14 days, and the influence of each drug on small bowel mucosa was evaluated by comparing pre‐ and post‐treatment capsule endoscopy findings. We measured the percentage of patients with small bowel mucosal injury following administration of these drugs as primary endpoint. Additionally, mean number of small bowel mucosal injuries per subject was analyzed as secondary endpoint. Results The percentage of subjects experiencing small bowel mucosal injury as primary endpoint was 10% in Group C and 70% in Group L after treatment. This magnitude of the difference of between Group C and Group L was statistically significant ( P = 0.031). The number of small bowel mucosal injuries as secondary endpoint differed significantly between the two groups, and the influence of celecoxib on small bowel injury was less than that of loxoprofen . Conclusion These results indicate that celecoxib has less influence on small bowel mucosa than loxoprofen and can be used safely.