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Side-effects of fluticasone in asthmatic children: no effects after dose reduction
M J Visser1, E van der Veer, D S Postma
1Dept of Pulmonology, University Hospital Groningen, P.O.Box 30,001, 9700 RB, Groningen, the Netherlands. M.Visser@int.azg.nl
Insights
High-dose fluticasone propionate (FP) in children with asthma reduced growth and adrenal function. Lower doses (≤200 microg.day(-1)) of FP appear safe for long-term childhood asthma management.
Area of Science:
- Pediatric Pulmonology
- Pharmacology
- Endocrinology
Background:
- Inhaled corticosteroids (ICS) are first-line therapy for persistent asthma.
- Fluticasone propionate (FP) is a commonly prescribed ICS.
- Long-term safety data, particularly regarding growth and systemic effects, are crucial for pediatric asthma management.
Purpose of the Study:
- To compare the long-term effects and side-effects of a step-down versus a constant dose of fluticasone propionate (FP) in children with chronic persistent asthma.
- To assess airways hyperresponsiveness (AHR) and systemic side-effects, including growth, bone parameters, and adrenal cortical function.
Main Methods:
- A 2-year, double-blind, prospective study involving 55 children (aged 6-10 years) with chronic persistent asthma.
- Comparison of a step-down FP dose regimen (1000 to 100 microg.day(-1)) versus a constant dose (200 microg.day(-1)).
- Assessment of AHR, growth velocity, bone turnover markers, and adrenal cortical function at regular intervals.
Main Results:
- Both treatment approaches improved AHR, with no significant long-term differences observed.
- Doses of 1000 and 500 microg.day(-1) FP were associated with dose-dependent reductions in growth velocity, adrenal function, and bone turnover compared to 200 microg.day(-1).
- Conventional doses (≤200 microg.day(-1)) demonstrated safety in long-term management.
Conclusions:
- High doses of fluticasone propionate (1000 and 500 microg.day(-1)) are linked to significant reductions in growth, bone turnover, and adrenal function in children.
- Conventional doses (≤200 microg.day(-1)) of FP are considered safe for the long-term management of childhood asthma.
- High-dose FP should be reserved for exceptional cases, such as persistent severe asthma, due to safety concerns.
Abstract:
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.
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