Lung function and symptom improvement with fluticasone propionate/salmeterol and ipratropium bromide/albuterol in COPD: Response by beta-agonist reversibility

This retrospective analysis of data from two multi-center, randomized, double-blind, parallel group studies compared the efficacy of fluticasone propionate/salmeterol (FSC) 250/50 mcg twice daily with ipratropium bromide/albuterol (IB/ALB) 36/206 mcg four times daily in albuterol-reversible (n = 320 [44%]) and non-reversible (n = 399 [56%]) patients with COPD. In reversible and non-reversible patients, both treatments significantly increased FEV(1)AUC(0-6h) from baseline and the magnitude of improvement was larger in reversible patients. FSC increased FEV(1)AUC(0-6h) by 1.46 +/- 0.08 and 1.98 +/- 0.13 I-h at Day 1 and Week 8, respectively, in reversible patients, compared with 0.71 +/- 0.06 and 0.94 +/- 0.10 I-h in non-reversible patients (p<0.001). With IB/ALB, increases were 1.46 +/- 0.08 and 1.19 +/- 0.11 I-h at Day I in reversible patients and Week 8, respectively, and 0.89 +/- 0.06 and 0.74 +/- 0.09 I-h (p <= 0.041) in non-reversible patients. After 8 weeks, in both the reversible and non-reversible populations, the FEV1 AUC(0-6h) significantly increased with FSC treatment (p <= 0.002) and significantly decreased with IB/ALB (p <= 0.010). In both reversibility groups, improvement in Transition Dyspnea Index (TDI) scores, overall daytime diary symptom scores and nocturnal symptom measures were significantly greater with FSC treatment compared with IB/ALB(p <= 0.044). Reversibility, status was not predictive of the magnitude of reduction in symptom scores. We conclude that both reversible and non-reversible patients receive greater clinical benefit with FSC compared with IB/ALB and acute bronchodilator reversibility, is not useful for differentiating patients based on symptomatic responses to FSC compared with IB/ALB. (C) 2008 Elsevier Ltd. All rights reserved.