Long-term safety of fluticasone propionate and nedocromil sodium on bone in children with asthma.
OBJECTIVE
Inhaled corticosteroids are recommended as first-line therapy for pediatric asthma. However, few controlled long-term studies have investigated their effect on bone mineral density (BMD) and growth.


METHODS
Children who were aged 6 to 14 years and had persistent asthma were randomized to 24 months' treatment with fluticasone propionate (FP) 200 micro g/d or nedocromil sodium (NS) 8 mg/d (if uncontrolled, maximum doses of 400 micro g/d and 16 mg/d, respectively). BMD was assessed blind and analyzed at a central facility on the basis of dual-energy x-ray absorptiometry measurements of the lumbar spine and femoral neck at months 0, 6, 12, and 24. Height was measured at months 0, 12, and 24. Efficacy parameters (lung function, asthma control, occurrence of exacerbations) were measured every 3 months.


RESULTS
In total, 174 children were randomized to treatment (87 received FP, and 87 received NS). At month 24, the adjusted mean percentage increase in lumbar spine BMD was 11.6% in the FP group compared with 10.4% in NS-treated children (95% confidence interval for treatment difference: -0.7% to 3.1%). The corresponding increases in femoral neck BMD were 8.9% and 8.5%, respectively. There was no significant difference in growth between the 2 groups: adjusted mean growth rates were 6.1 cm/y with FP and 5.8 cm/y with NS. FP was significantly superior for every efficacy parameter investigated and was similarly well tolerated as NS.


CONCLUSIONS
The long-term effects of FP and NS on BMD accrual and growth are similar among children with asthma. The benefit:risk ratio of FP may be considered superior to that of NS.
Roux
Christian
C
Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Université René Descartes, Paris, France. christian.roux@cch.ap-hop-paris.fr
Kolta
Sami
S
Desfougères
Jean-Luc
JL
Minini
Pascal
P
Bidat
Etienne
E
D000280:Administration, Inhalation; D000293:Adolescent; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D001827:Body Height / Q000187:drug effects; D015519:Bone Density / Q000187:drug effects; D001842:Bone and Bones / Q000187:drug effects*; D002648:Child; D002657:Child Development / Q000187:drug effects; D005260:Female; D000068298:Fluticasone; D006801:Humans; D008137:Longitudinal Studies; D008159:Lumbar Vertebrae / Q000187:drug effects; D008297:Male; D017835:Nedocromil / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D012727:Sex Characteristics; D016896:Treatment Outcome
D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D017835:Nedocromil; D000068298:Fluticasone