Document Detail

Rofecoxib and early relapse of inflammatory bowel disease: an open-label trial.
MedLine Citation:
PMID:  15043516     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The safety and efficacy of selective cyclo-oxygenase-2 inhibitors in inflammatory bowel disease are under investigation. AIM: 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.
L Biancone; C Tosti; A Geremia; D Fina; C Petruzziello; S Emerenziani; F Pallone
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Publication Detail:
Type:  Clinical Trial; Controlled Clinical Trial; Journal Article    
Journal Detail:
Title:  Alimentary pharmacology & therapeutics     Volume:  19     ISSN:  0269-2813     ISO Abbreviation:  Aliment. Pharmacol. Ther.     Publication Date:  2004 Apr 
Date Detail:
Created Date:  2004-03-26     Completed Date:  2004-07-20     Revised Date:  2005-11-17    
Medline Journal Info:
Nlm Unique ID:  8707234     Medline TA:  Aliment Pharmacol Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  755-64     Citation Subset:  IM    
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.
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MeSH Terms
Anti-Inflammatory Agents, Non-Steroidal / adverse effects,  therapeutic use*
Arthralgia / drug therapy*
Colitis, Ulcerative / drug therapy*
Crohn Disease / drug therapy*
Cyclooxygenase Inhibitors / adverse effects,  therapeutic use*
Lactones / adverse effects,  therapeutic use*
Middle Aged
Prospective Studies
Treatment Outcome
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 0/Cyclooxygenase Inhibitors; 0/Lactones; 0/Sulfones; 0/rofecoxib

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