Effects of long-acting bronchodilators in COPD patients according to COPD severity and ICS use

Background: Indacaterol is a once-daily, long-acting beta(2)-agonist bronchodilator that improves dyspnoea and health status in patients with moderate-to-severe COPD. While its bronchodilator effects have been shown to be maintained in different patient subgroups, effects on clinical outcomes in certain subgroups are not yet defined. Methods: Post-hoc analysis of pooled clinical study data to investigate efficacy and safety of indacaterol compared with placebo and other long-acting bronchodilators (formoterol, salmeterol, open-label tiotropium) in patient subgroups defined by COPD severity (GOLD stage II or III; n = 4082) and ICS use at baseline (no/yes; n = 4088). Efficacy outcomes were trough (24-h post-dose) FEV1, dyspnoea (transition dyspnoea index; TDI) and health status (St George's Respiratory Questionnaire; SGRQ) after 26 weeks. Results: All active treatments significantly improved trough FEV1 and dyspnoea compared with placebo, and all apart from open-label tiotropium improved health status compared with placebo. Among active treatments, indacaterol 150 mu g had the best overall efficacy profile in the GOLD II and no-ICS subgroups. In the GOLD III and ICS subgroups, indacaterol 300 mu g had the best overall efficacy, including a marked effect on dyspnoea (1.4-point improvement in TDI total score vs. placebo; p < 0.001). Within subgroups, the incidence of adverse events was similar between treatments. Conclusion: Indacaterol maintained its efficacy regardless of disease severity or use of concurrent ICS. Indacaterol 150 mu g had the best overall efficacy profile in the GOLD stage II patients while, in patients with more severe disease, indacaterol 300 mu g provided useful improvements in dyspnoea. (C) 2012 Elsevier Ltd. All rights reserved.