Background: The safety and efficacy of selective cyclooxygenase-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.

Biancone L., T.C. (2004). Rofecoxib and early relapse of inflammatory bowel disease: an open-label trial, 19(7), 755-764 [10.1111/j.1365-2036.2004.01907.x].

Rofecoxib and early relapse of inflammatory bowel disease: an open-label trial

BIANCONE, LIVIA;PALLONE, FRANCESCO
2004

Abstract

Background: The safety and efficacy of selective cyclooxygenase-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.
Pubblicato
Rilevanza internazionale
Articolo
Sì, ma tipo non specificato
Settore MED/12 - Gastroenterologia
English
budesonide; ciprofloxacin; cyclooxygenase 2 inhibitor; domperidone; mesalazine; methotrexate; metronidazole; nonsteroid antiinflammatory agent; omeprazole; proton pump inhibitor; rofecoxib; sulfalazine; abdominal pain; adult; aged; arthralgia; article; clinical article; clinical trial; controlled clinical trial; controlled study; Crohn disease; diarrhea; disease association; drug efficacy; drug safety; dyspepsia; enteritis; epigastric pain; female; gastrointestinal symptom; heartburn; human; male; melena; open study; priority journal; prospective study; relapse; side effect; treatment outcome; ulcerative colitis; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthralgia; Colitis, Ulcerative; Crohn Disease; Cyclooxygenase Inhibitors; Female; Humans; Lactones; Male; Middle Aged; Prospective Studies; Recurrence; Sulfones; Treatment Outcome
Biancone L., T.C. (2004). Rofecoxib and early relapse of inflammatory bowel disease: an open-label trial, 19(7), 755-764 [10.1111/j.1365-2036.2004.01907.x].
Biancone, L; Tosti, C; Geremia, A; Fina, D; Petruzziello, C; Emerenziani, S; Pallone, F
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2108/28781
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