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Open Respir Med J. 2012;6:37-43. doi: 10.2174/1874306401206010037. Epub 2012 Jun 21.

Clinical and economic outcomes associated with low-dose fluticasone propionate versus montelukast in children with asthma aged 4 to 11 years.

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  • 1GlaxoSmithKline, Research Triangle Park, North Carolina, USA.



Inhaled corticosteroids (ICS) are preferred first-line controller agents for adults and adolescents with asthma. There is limited effectiveness data comparing ICS to leukotriene receptor antagonists (LTRA) in children with asthma aged 4 to 11 years.


A retrospective, matched cohort study was conducted using medical and pharmacy claims data. Asthma patients (ICD-9, 493.xx) naïve to any asthma controller therapy, and having ≥1 dispensing of fluticasone propionate 44 mcg (FP44), an ICS, or montelukast any dose (MON), an LTRA, were identified. Drug cohorts were matched (1:2) using propensity scores. Outcomes during follow-up included asthma-related ED visits, composite measure of asthma-related ED/hospital visit, asthma-related costs per month, and monthly rescue medication use. Statistical differences between cohorts were evaluated using multivariate regression models.


The final matched sample included 6,636 patients (FP44=2,212; MON=4,424). During follow-up, the FP44 cohort had a 29% significantly lower risk of an asthma-related ED visit (Hazard ratio (95% CI) =0.71 (0.52, 0.96)) compared to the MON cohort. Monthly asthma-related costs were significantly reduced on average by 36% in the FP44 compared to the MON cohort ($48 vs $75, p<0.05). Use of short-acting beta-agonists per month were similar between cohorts but monthly adjusted number of oral corticosteroid prescriptions were significantly lower in the FP44 compared to the MON cohort (0.03 vs 0.04, p<0.001).


Initiation of FP44 versus MON in children with asthma aged 4 to 11 years is associated with a significant reduction in asthma-related ED visits, costs, and oral corticosteroid use.


Asthma; costs.; inhaled corticosteroids; leukotriene; outcomes; pediatrics; receptor antagonists

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