Evidence from controlled trials in patients with COPD suggest that maintenance therapy with fluticasone/salmeterol combination (FS) may improve lung function and symptoms compared with inhaled corticosteroids alone (IC), salmeterol alone (SL), or ipratropium with albuterol (IA). The objective of this study was to compare risk of COPD related emergency department (ED) visit or hospitalization in COPD patients receiving different initial maintenance therapies.
Data from a large US health-insurance claims database was used to identify patients with diagnoses of COPD (ICD-9-CM 491.xx, 492.xx, 496.xx) who initiated inhaled maintenance therapy with FS, IC, SL, ipratropium (IP), or IA between 1/98-12/04. Risk of COPD-related ED/hospitalization was analyzed using repeated-measures logistic regression analysis with exposure to study therapies and other characteristics (age, sex, emphysema diagnosis, Charlson comorbidity index, use of short-acting beta agonists, oral corticosteroids, antibiotics, or oxygen therapy, and ED visit/hospitalization in the previous year) included as time-dependent covariates.
36,076 subjects were identified with 41,268 person years of follow-up. 3,425 experienced a COPD-related ED visit/hospitalization during follow-up (8.1 per 100 person years). The unadjusted rate of ED visit/hospitalization per 100 person years of exposure to study therapy was 6.8 for FS, 11.0 for IC, 9.1 for SL, 30.2 for IP, 21.9 for IA, and 18.1 for combinations of two or more study therapies. In multivariate analysis, exposure to FS was associated with lower risk of COPD-related ED visit/hospitalization compared with IC (adjusted odds ratio [OR] 0.68, 95% confidence interval [CI] 0.55-0.83), IP (OR 0.41, 95%CI 0.34-0.50), IA (OR 0.39, 95%CI 0.33-0.46), and combinations of two or more study therapies (OR 0.46, 95%CI 0.38-0.54). Results were similar when patients with an asthma diagnosis were excluded, as well as for all-cause ED visit/hospitalization.
Therapy with FS is associated with reduced risk of COPD-related ED visit/hospitalization compared with IC, IP, or IA.
Although results of observational studies alone are insufficient to establish causality, these findings provide further evidence of clinical benefits for FS as initial therapy in patients with COPD.
Thomas Delea, Employee R Borker and R Borker are employees of GSK.; Grant monies (from industry related sources) This study was funded by GSK.; Consultant fee, speaker bureau, advisory committee, etc. T Delea and M Hagiwara are employees of PAI which has received research funding and consulting fees from GSK.