High-dose ibuprofen in cystic fibrosis: Canadian safety and effectiveness trial.

Author(s): Lands LC, Milner R, Cantin AM, Manson D, Corey M

Affiliation(s): Department of Pediatrics, Montreal Children's Hospital-McGill University Health Center, Montreal, Quebec, Canada. larry.lands@muhc.mcgill.ca

Publication date & source: 2007-09, J Pediatr., 151(3):249-54. Epub 2007 Jun 26.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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 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.