Safety of formoterol in children and adolescents: experience from asthma clinical trials
(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
- Price, J. F. ; Radner, F. ; Lenney, W. and Lindberg, Bengt LU
- organization
- publishing date
- 2010
- 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
- pmid:21030368
- 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
- 2016-04-01 13:19:20
- date last changed
- 2025-04-04 15:31:13
@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}},
doi = {{10.1136/adc.2010.183814}},
volume = {{95}},
year = {{2010}},
}