Rofecoxib and early relapse of inflammatory bowel disease: an open-label trial.
BACKGROUND
The safety and efficacy of selective cyclo-oxygenase-2 inhibitors in inflammatory bowel disease are under investigation.


OBJECTIVE
To assess, in a prospective, open-label trial, the efficacy and safety of rofecoxib (12.5 mg/day) in inflammatory bowel disease patients and controls.


METHODS
The inflammatory bowel disease group included 45 inactive patients (25 Crohn's disease; 20 ulcerative colitis) with associated arthralgia. The control group included 30 dyspeptic patients. The efficacy and safety of rofecoxib were assessed in inflammatory bowel disease patients and controls before and after treatment (range, 3 days to 3 months).


RESULTS
In inflammatory bowel disease, nine of the 45 patients (20%) required rofecoxib withdrawal due to gastrointestinal symptoms inducing clinical relapse, which subsided on drug discontinuation. The percentage of patients requiring rofecoxib discontinuation was comparable in patients with Crohn's disease and ulcerative colitis (20% vs. 20%), but was higher in inflammatory bowel disease patients than in controls (20% vs. 3%; P < 0.001). In inflammatory bowel disease, arthralgia relief was reported by 32 patients (71%): complete relief by eight patients (18%) and partial relief by 24 (53%). Thirteen patients (29%) reported no benefit. A comparable percentage of inflammatory bowel disease patients and controls reported arthralgia relief (71% vs. 70%).


CONCLUSIONS
Rofecoxib appears to control arthralgia in almost two-thirds of inflammatory bowel disease patients. Side-effects requiring drug discontinuation are observed, however, in almost one-quarter of patients.
Biancone
L
L
Cattedra di Gastroenterologia, Dipartimento di Medicina Interna, Center of Excellence for the Study of the Genomic Risk of Complex Multifactorial Diseases, Università degli Studi di Roma Tor Vergata, Rome, Italy. biancone@med.uniroma2.it
Tosti
C
C
Geremia
A
A
Fina
D
D
Petruzziello
C
C
Emerenziani
S
S
Pallone
F
F
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D018771:Arthralgia / Q000188:drug therapy*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007783:Lactones / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D013450:Sulfones; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib