Side-effects of fluticasone in asthmatic children: no effects after dose reduction

• Published in: The European respiratory journal Vol. 24; no. 3; pp. 420 - 425
• Main Authors: Visser, M.J, van der Veer, E, Postma, D.S, Arends, L.R, de Vries, T.W, Brand, P.L.P, Duiverman, E.J
• Format: Journal Article
• Language: English
• Published: England Eur Respiratory Soc 01.09.2004
• Subjects: Adrenal Cortex - drug effects; Androstadienes - administration & dosage; Androstadienes - adverse effects; Androstadienes - therapeutic use; Asthma - drug therapy; Bone and Bones - drug effects; Bone Density - drug effects; Bronchial Hyperreactivity - drug therapy; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; Bronchodilator Agents - therapeutic use; Child; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fluticasone; Growth - drug effects; Humans; Male; Prospective Studies
• ISSN: 0903-1936; 1399-3003
• DOI: 10.1183/09031936.04.00023904

To assess long-term effects and side-effects of fluticasone propionate (FP), a 2-yr study was performed, comparing a step-down dose approach (1,000 microg.day(-1), with reductions every 2 months to 500, 200 and 100 microg.day(-1) for the remainder of the study) versus a constant dose (200 microg.day(-1)). In 55 children with chronic persistent asthma, aged 6-10 yrs, airways hyperresponsiveness (AHR) and systemic side-effects (height, bone parameters and adrenal cortical function) were assessed at predetermined intervals in a double-blind prospective 2-yr study. AHR improved after 4 months treatment with 1,000 microg.day(-1) FP followed by 500 microg.day(-1), without significant differences during long-term treatment between the two approaches. Dose-dependent reduction of growth velocity, adrenal cortical function and biochemical bone turnover was found during therapy with 1,000 and 500 microg.day(-1) FP when compared with 200 microg.day(-1). In conclusion, doses of 1,000 and 500 microg.day(-1) fluticasone propionate are associated with marked reductions of growth velocity, bone turnover and adrenal cortical function. However, conventional doses (< or =200 microg.day(-1) fluticasone propionate) appear to be safe in the long-term management of childhood asthma. From a safety point of view, high doses of fluticasone propionate should only be prescribed in exceptions, e.g. in persistent severe asthma.