title: Safety of long-acting beta agonists and inhaled corticosteroids in children and adolescents with asthma.
abstract: The introduction of long-acting beta agonists (LABAs) was considered a major advance in bronchodilator therapy for adult, as well as pediatric, patients with asthma. However, the use of LABAs has raised safety concerns, especially the potential for severe asthma exacerbations (SAEs) resulting in hospitalizations or even death. Meanwhile, the use of inhaled corticosteroids (ICSs), a cornerstone in the treatment of mild-to-severe persistent asthma, has been associated with growth suppression in children. The purpose of this review was to identify and discuss the major published safety studies surrounding LABA, ICS, and combined LABA/ICS usage in children. By way of a critical search for influential published clinical trials, meta-analyses, and observational studies, six studies relevant to the safety of LABA monotherapy, seven studies relevant to ICS monotherapy, and four studies on the subject of LABA/ICS combination usage were identified and reviewed. Based on the reviewed literature, the controversy surrounding these anti-asthma medications was clearly exposed. On the one hand, there is some evidence that LABA monotherapy may be associated with SAEs and asthma-related death, while ICS monotherapy may be associated with a higher risk of growth suppression. On the other hand, the concurrent use of a LABA with an ICS has been associated with positive outcomes including symptom reduction and reduced rate and severity of exacerbations. Further clinical research is warranted and has been called for by the US Food and Drug Administration.
authors.affiliation: Division of Pharmacy Practice and Administrative Sciences, James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA.
authors.forename: Ying
authors.initials: Y
authors.lastname: Xia
authors.affiliation: Division of Pharmacy Practice & Administrative Sciences, James L. Winkle College of Pharmacy, and Carl H. Lindner College of Business, University of Cincinnati, Cincinnati, OH, USA.
authors.forename: Christina M L
authors.initials: CM
authors.lastname: Kelton
authors.affiliation: College of Medicine, State University of New York at Buffalo, Buffalo, NY, USA.
authors.forename: Liang
authors.initials: L
authors.lastname: Xue
authors.affiliation: University of Cincinnati, James L. Winkle College of Pharmacy, 3225 Eden Avenue, Cincinnati, OH 45267-0004, USA.
authors.forename: Jeff J
authors.initials: JJ
authors.lastname: Guo
authors.affiliation: Division of Pharmacy Practice and Administrative Sciences, James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA.
authors.forename: Boyang
authors.initials: B
authors.lastname: Bian
authors.affiliation: Division of Pharmacy Practice and Administrative Sciences, James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA.
authors.forename: Patricia R
authors.initials: PR
authors.lastname: Wigle
keywords: Drug safety; growth suppression; inhaled corticosteroids; long-acting beta-agonists; pediatric asthma; serious asthma exacerbations
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