Clinical use of Ibuprofen is associated with slower FEV1 decline in children with cystic fibrosis.
BACKGROUND
High-dose ibuprofen in a 4-year controlled trial slowed FEV(1) decline in young subjects with cystic fibrosis, but the effectiveness of ibuprofen has not been assessed in a large group of patients treated clinically with this therapy.


OBJECTIVE
To assess the effect of ibuprofen therapy on FEV(1) decline in children and adolescents with cystic fibrosis, using observational data from the Cystic Fibrosis Foundation Patient Registry.


METHODS
The rate of decline in FEV(1) percent predicted over 2-7 years among patients age 6-17 years with FEV(1) > 60% predicted, and who were treated with ibuprofen (1,365), was compared with patients of similar age and disease severity who were not treated with this therapy (8,960). Multilevel repeated-measures mixed-regression models were used to estimate rates of decline, adjusting for characteristics and therapies that influenced FEV(1) decline. Adverse effects were compared among those treated versus not treated with ibuprofen.


RESULTS
FEV(1) declined less rapidly among patients treated with ibuprofen (difference, 0.60% predicted per year; 95% confidence interval, 0.31 to 0.89; P < 0.0001); a 29% reduction in slope based on an average decline of 2.08% predicted per year for patients not treated. Those treated with ibuprofen were more likely to have an episode of gastrointestinal bleeding requiring hospitalization, but the occurrence was rare in both groups (annual incidence, 0.37 vs. 0.14%; relative risk, 2.72; P < 0.001).


CONCLUSIONS
Slower rates of FEV(1) decline are seen in children and adolescents with cystic fibrosis who are treated with ibuprofen. The apparent benefits of ibuprofen therapy outweigh the small risk of gastrointestinal bleeding.
Konstan
Michael W
MW
Rainbow Babies and Children's Hospital, 11100 Euclid Avenue, Cleveland, OH 44106, USA. michael.konstan@case.edu
Schluchter
Mark D
MD
Xue
Wei
W
Davis
Pamela B
PB
D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D003550:Cystic Fibrosis / Q000188:drug therapy* / Q000503:physiopathology*; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects*; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced / Q000453:epidemiology / Q000628:therapy; D006760:Hospitalization; D006801:Humans; D007052:Ibuprofen / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D008297:Male; D012042:Registries
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007052:Ibuprofen