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Drug Safety

, Volume 29, Issue 7, pp 599–612 | Cite as

Clinical Safety of Inhaled Corticosteroids for Asthma in Children

An Update of Long-Term Trials
  • Søren Pedersen
Review Article

Abstract

Inhaled corticosteroids are established as the mainstay of maintenance therapy for chronic asthma. However, there remains some debate regarding the safety of long-term use of these agents, particularly in children. This concern mainly stems from the findings of short-term studies assessing the effects of inhaled corticosteroids on lower leg growth rate or the hypothalamic-pituitary-adrenal axis. However, the clinical relevance of these findings to long-term treatment is unknown and significant uncertainty exists regarding the predictive value of changes in cortisol levels and clinically relevant changes in growth or bone mineral density.

To assess the safety of long-term use of inhaled corticosteroids in children with asthma, a systematic review of the literature was performed focusing on randomised, controlled studies of ≥12 months’ duration, to obtain data with maximum relevance to clinical practice. Specific searches were conducted to identify studies examining each of the following three areas: growth, bone mineral density and cortisol levels.

Fourteen studies met the inclusion criteria for statural growth, four for bone mineral density, and ten for cortisol levels. There was some evidence of a small decrease in statural growth during the initial period of inhaled corticosteroid therapy. This effect was more marked at daily doses of >200μg and did not apply to all treatment regimens. Studies examining final attained adult height found no difference between patients treated with inhaled corticosteroids and those receiving nonsteroidal therapy. None of the studies investigating effects on bone mineral density found any adverse effects of inhaled corticosteroid therapy. Finally, recommended doses of inhaled corticosteroids generally had little or no effect on plasma- or urinary-cortisol levels versus nonsteroidal therapy.

In conclusion, this literature review supports the theory that recommended doses of inhaled corticosteroids can be administered to children for the long-term management of asthma with minimal risk of clinically relevant adverse effects on growth, bone density or cortisol levels.

Keywords

Bone Mineral Density Cortisol Level Budesonide Fluticasone Propionate Nedocromil 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

Dr Pedersen has been on advisory boards and lectured for Altana, AstraZeneca, GlaxoSmithKline and Merck. Neither Dr Pedersen nor his family holds shares in any pharmaceutical company and he has no other relationship with, or economic interest in, a pharmaceutical company.

The development of this manuscript was supported by an unrestricted educational grant from GlaxoSmithKline, which involved help from a medical writer, Ken Sutor, Fishawack Communications.

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Copyright information

© Adis Data Information BV 2006

Authors and Affiliations

  1. 1.Department of PaediatricsUniversity of Southern Denmark, Kolding HospitalKoldingDenmark

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