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Safety of formoterol in children and adolescents: experience from asthma clinical trials

Price, J. F.; Radner, F.; Lenney, W. and Lindberg, Bengt LU (2010) In Archives of Disease in Childhood 95(12). p.1047-1053
Abstract
Background The safety of long-acting beta(2) agonist (LABA) therapy in asthma remains controversial but no large scale analyses have been published of LABA safety in children. Methods The frequency of asthma-related deaths and hospitalisations following formoterol use in children (4-11 years) and adolescents (12-17 years), compared with non-LABA treatment, was assessed in all AstraZeneca-sponsored, randomised, controlled, parallel-group trials (>= 3 months) where formoterol was used as maintenance and/or as reliever therapy. Results 11 849 children and adolescents under the age of 18 years from 41 trials were identified, 82% of whom used an inhaled corticosteroid (ICS) as concomitant medication. The number of asthma-related deaths (one... (More)
Background The safety of long-acting beta(2) agonist (LABA) therapy in asthma remains controversial but no large scale analyses have been published of LABA safety in children. Methods The frequency of asthma-related deaths and hospitalisations following formoterol use in children (4-11 years) and adolescents (12-17 years), compared with non-LABA treatment, was assessed in all AstraZeneca-sponsored, randomised, controlled, parallel-group trials (>= 3 months) where formoterol was used as maintenance and/or as reliever therapy. Results 11 849 children and adolescents under the age of 18 years from 41 trials were identified, 82% of whom used an inhaled corticosteroid (ICS) as concomitant medication. The number of asthma-related deaths (one 13-year-old boy among 7796 formoterol-treated patients, and none among 4053 non-LABA-treated patients) was too low to allow any between-group comparison. The frequency of patients with asthma-related hospitalisations was not different in formoterol-treated versus non-LABA-treated patients, either in children (1.16% (38/3263) vs 1.11% (24/2165)) or in adolescents (0.51% (23/4533) vs 0.85% (16/1888)). Asthma-related hospitalisations based on daily dose of formoterol were: (A) 4.5 or 9 mu g: 1.9% (18/980); (B) 18 mu g: 0.5% (14/2870); (C) 36 mu g: 0% (0/67); and (D) variable dosing: 0.75% (29/3879). There was no difference between formoterol-treated and non-LABA-treated patients as regards ethnicity. Conclusions Formoterol use in children and adolescents (4-17 years) with asthma in this large study where the majority are prescribed concomitant ICS is not associated with any increased risk of asthma-related hospitalisations. The results are not influenced by dose or ethnicity. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Archives of Disease in Childhood
volume
95
issue
12
pages
1047 - 1053
publisher
BMJ Publishing Group
external identifiers
  • wos:000284619100022
  • scopus:78649840031
ISSN
0003-9888
DOI
10.1136/adc.2010.183814
language
English
LU publication?
yes
id
d9381919-55a1-460a-8c84-4001368ae5c7 (old id 1752656)
date added to LUP
2011-01-04 07:37:11
date last changed
2018-05-29 10:27:06
@article{d9381919-55a1-460a-8c84-4001368ae5c7,
  abstract     = {Background The safety of long-acting beta(2) agonist (LABA) therapy in asthma remains controversial but no large scale analyses have been published of LABA safety in children. Methods The frequency of asthma-related deaths and hospitalisations following formoterol use in children (4-11 years) and adolescents (12-17 years), compared with non-LABA treatment, was assessed in all AstraZeneca-sponsored, randomised, controlled, parallel-group trials (>= 3 months) where formoterol was used as maintenance and/or as reliever therapy. Results 11 849 children and adolescents under the age of 18 years from 41 trials were identified, 82% of whom used an inhaled corticosteroid (ICS) as concomitant medication. The number of asthma-related deaths (one 13-year-old boy among 7796 formoterol-treated patients, and none among 4053 non-LABA-treated patients) was too low to allow any between-group comparison. The frequency of patients with asthma-related hospitalisations was not different in formoterol-treated versus non-LABA-treated patients, either in children (1.16% (38/3263) vs 1.11% (24/2165)) or in adolescents (0.51% (23/4533) vs 0.85% (16/1888)). Asthma-related hospitalisations based on daily dose of formoterol were: (A) 4.5 or 9 mu g: 1.9% (18/980); (B) 18 mu g: 0.5% (14/2870); (C) 36 mu g: 0% (0/67); and (D) variable dosing: 0.75% (29/3879). There was no difference between formoterol-treated and non-LABA-treated patients as regards ethnicity. Conclusions Formoterol use in children and adolescents (4-17 years) with asthma in this large study where the majority are prescribed concomitant ICS is not associated with any increased risk of asthma-related hospitalisations. The results are not influenced by dose or ethnicity.},
  author       = {Price, J. F. and Radner, F. and Lenney, W. and Lindberg, Bengt},
  issn         = {0003-9888},
  language     = {eng},
  number       = {12},
  pages        = {1047--1053},
  publisher    = {BMJ Publishing Group},
  series       = {Archives of Disease in Childhood},
  title        = {Safety of formoterol in children and adolescents: experience from asthma clinical trials},
  url          = {http://dx.doi.org/10.1136/adc.2010.183814},
  volume       = {95},
  year         = {2010},
}