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). Study design In this multicenter, double-blinded, placebo-controlled trial, a total of 142 patients age 6 to 18 years with mild lung disease (forced exp...

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Bibliographic Details
Published in:The Journal of pediatrics 2007-09, Vol.151 (3), p.249-254
Main Authors: Lands, Larry C., MD, PhD, Milner, Ruth, PhD, Cantin, André M., MD, Manson, David, MD, Corey, Mary, PhD
Format: Article
Language:English
Subjects:
Adolescent
Anti-Inflammatory Agents, Non-Steroidal - administration & dosage
Anti-Inflammatory Agents, Non-Steroidal - pharmacokinetics
Biological and medical sciences
Canada
Child
Chromatography, High Pressure Liquid
Cystic Fibrosis - drug therapy
Double-Blind Method
Errors of metabolism
Female
Forced Expiratory Volume
General aspects
Humans
Ibuprofen - administration & dosage
Ibuprofen - pharmacokinetics
Male
Medical sciences
Metabolic diseases
Miscellaneous hereditary metabolic disorders
Patient Selection
Pediatrics
Regression Analysis
Vital Capacity
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Summary:Objective To assess the effectiveness and safety of high-dose ibuprofen when used as part of routine therapy in patients with cystic fibrosis (CF). Study design 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 μg/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.
ISSN:0022-3476
1097-6833
DOI:10.1016/j.jpeds.2007.04.009