Safety of selective cyclooxygenase-2 inhibitors in inflammatory bowel disease.
OBJECTIVE
Nonsteroidal anti-inflammatory drugs (NSAIDs) are relatively contraindicated in patients with inflammatory bowel disease (IBD) for fear of disease aggravation. Cyclooxygenase-2 inhibitors have fewer GI side effects than traditional NSAIDs in unselected patients. We report the safety of these agents in patients with IBD.


METHODS
Patients with Crohn's disease, ulcerative colitis, or pouchitis who used celecoxib or rofecoxib were identified from computerized prescription records. A retrospective chart review was conducted. Concomitant medications, past NSAID use, indication for cyclooxygenase-2 inhibitor, dose, and duration were obtained. IBD disease activity before cyclooxygenase-2 inhibitor use was graded using a modified disease activity index. Change in disease activity was graded as improved, no change, or worsened. Patients were contacted to provide data not found in the charts. The proportion of patients receiving cyclooxygenase-2 inhibitors who experienced exacerbation of IBD was determined.


RESULTS
Eleven patients were treated with celecoxib (median dose = 200 mg/day), and 16 patients were treated with rofecoxib (median dose = 25 mg/day). Median duration of therapy was 9 months (range = 1 wk-22 months). The drug was beneficial in 14 patients, of partial benefit in eight, and of no benefit in five. Two patients (7.4%) (95% CI = 2-23%) had aggravations of IBD. Three patients (11%) had other adverse events (renal insufficiency, rash, and asymptomatic colonic ulceration). All adverse events were reversible.


CONCLUSIONS
Our preliminary results suggest that cyclooxygenase-2 inhibitors may be safe and beneficial in most patients with IBD. A placebo-controlled trial to confirm these preliminary observations is needed.
Mahadevan
Uma
U
Division of Gastroenterology and Hepatology, University of California, San Francisco, 55905, USA.
Loftus
Edward V
EV
Tremaine
William J
WJ
Sandborn
William J
WJ
D000328:Adult; D000368:Aged; D000068579:Celecoxib; D003093:Colitis, Ulcerative / Q000139:chemically induced* / Q000503:physiopathology; D003424:Crohn Disease / Q000139:chemically induced* / Q000503:physiopathology; D051546:Cyclooxygenase 2; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects*; D018450:Disease Progression; D005260:Female; D006801:Humans; D007422:Intestines / Q000187:drug effects / Q000503:physiopathology; D007527:Isoenzymes / Q000009:adverse effects* / Q000037:antagonists & inhibitors*; D007783:Lactones / Q000009:adverse effects*; D008297:Male; D008565:Membrane Proteins; D008875:Middle Aged; D019449:Pouchitis / Q000139:chemically induced* / Q000503:physiopathology; D011451:Prostaglandin-Endoperoxide Synthases / Q000009:adverse effects*; D011720:Pyrazoles; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000009:adverse effects*; D013450:Sulfones
D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors; D007527:Isoenzymes; D007783:Lactones; D008565:Membrane Proteins; D011720:Pyrazoles; D013449:Sulfonamides; D013450:Sulfones; C116926:rofecoxib; D051546:Cyclooxygenase 2; C496540:PTGS2 protein, human; D011451:Prostaglandin-Endoperoxide Synthases; D000068579:Celecoxib