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PEDIATRICS Vol. 111 No. 6 June 2003, pp. e706-e713

ELECTRONIC ARTICLE

Long-Term Safety of Fluticasone Propionate and Nedocromil Sodium on Bone in Children With Asthma

Christian Roux, MD, PhD*, Sami Kolta, MD*, Jean-Luc Desfougères, MD{ddagger}, Pascal Minini, PhD{ddagger} and Etienne Bidat, MD§

* Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Université René Descartes, Paris, France
{ddagger} GlaxoSmithKline, Marly Le Roi, France
§ Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris, Boulogne-Billancourt, France

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 µg/d or nedocromil sodium (NS) 8 mg/d (if uncontrolled, maximum doses of 400 µg/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.

Key Words: bone mineral density • fluticasone propionate • long-term safety • height

Abbreviations: ICS, inhaled corticosteroid • BMD, bone mineral density • FP, fluticasone propionate • NS, nedocromil sodium • PEFR, peak expiratory flow rate • FEV1, forced expiratory volume in 1 second • BHR, bronchial hyperreactivity • DXA, dual-energy x-ray absorptiometry • CI, confidence interval • ITT, intention-to treat

Received for publication Oct 8, 2002; Accepted Jan 30, 2003.




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