High-dose ibuprofen in cystic fibrosis: Canadian safety and effectiveness trial.
OBJECTIVE
To assess the effectiveness and safety of high-dose ibuprofen when used as part of routine therapy in patients with cystic fibrosis (CF).


METHODS
In this multicenter, double-blinded, placebo-controlled trial, a total of 142 patients age 6 to 18 years with mild lung disease (forced expiratory volume in 1 minute [FEV1] > 60 predicted) were randomized to receive either high-dose ibuprofen (70 subjects, 20 to 30 mg/kg/twice daily, adjusted to a peak serum concentration of 50 to 100 mug/mL) or placebo (72 subjects) for a 2-year period. The primary outcome was the annualized rate of change in FEV1% predicted.


RESULTS
The patients in the high-dose ibuprofen group exhibited a significant reduction in the rate of decline of forced vital capacity percent predicted (0.07 +/- 0.51 vs -1.62 +/- 0.52; P = .03), but not FEV1%. The ibuprofen group also spent fewer days in hospital after adjusting for age (1.8 vs 4.1 days per year; P = .07). A total of 11 patients (4 in the ibuprofen group and 7 in the placebo group) withdrew due to adverse events.


CONCLUSIONS
High-dose ibuprofen has a significant effect on slowing the progression of lung disease in CF and generally is well tolerated.
Lands
Larry C
LC
Department of Pediatrics, Montreal Children's Hospital-McGill University Health Center, Montreal, Quebec, Canada. larry.lands@muhc.mcgill.ca
Milner
Ruth
R
Cantin
André M
AM
Manson
David
D
Corey
Mary
M
D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000493:pharmacokinetics; D002170:Canada; D002648:Child; D002851:Chromatography, High Pressure Liquid; D003550:Cystic Fibrosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage* / Q000493:pharmacokinetics; D008297:Male; D018579:Patient Selection; D012044:Regression Analysis; D014797:Vital Capacity
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007052:Ibuprofen