Exacerbation heterogeneity in COPD: subgroup analyses from the FLAME study

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Title: Exacerbation heterogeneity in COPD: subgroup analyses from the FLAME study
Authors: Vogelmeier, CF
Chapman, KR
Miravitlles, M
Roche, N
Vestbo, J
Thach, C
Banerji, D
Fogel, R
Patalano, F
Olsson, P
Kostikas, K
Wedzicha, JA
Item Type: Journal Article
Abstract: Background: The FLAME study compared once-daily indacaterol/glycopyrronium (IND/GLY) 110/50 µg with twice-daily salmeterol/fluticasone (SFC) 50/500 µg in symptomatic patients with moderate to very severe COPD and a history of exacerbations in the previous year. Methods: This prespecified and post hoc subgroup analysis evaluated treatment efficacy on 1) moderate/severe exacerbations according to prior exacerbation history and treatment, and 2) types of exacerbations according to health care resource utilization (HCRU) during 1-year follow-up. Results: IND/GLY reduced the rate of moderate/severe exacerbations versus SFC in patients with a history of 1 exacerbation (rate ratio [RR]: 0.83, 95% CI: 0.75–0.93), ≥2 exacerbations (RR: 0.85, 95% CI: 0.70–1.03) and ≥2 exacerbations or ≥1 hospitalization in the previous year (RR: 0.86, 95% CI: 0.74–1.00). Prolonged time-to-first exacerbation was observed in all the groups according to exacerbation history. Moderate/severe exacerbations decreased with IND/GLY versus SFC, independent of previous treatment. IND/GLY significantly reduced rates of moderate/severe exacerbations treated with antibiotics (RR: 0.79, 95% CI: 0.67–0.93) and systemic corticosteroids and antibiotics (RR: 0.80, 95% CI: 0.70–0.91); rates of exacerbations treated with systemic corticosteroids alone were comparable (RR: 0.99, 95% CI: 0.80–1.22). Conclusion: Overall, IND/GLY demonstrated consistent beneficial effects versus SFC on moderate/severe exacerbations, independent of prior exacerbation history or treatment. The efficacy of IND/GLY on exacerbation prevention was superior to SFC for exacerbations treated with antibiotics with/without systemic corticosteroids and was similar for exacerbations treated with systemic corticosteroids alone.
Issue Date: 10-Apr-2018
Date of Acceptance: 4-Mar-2018
ISSN: 1176-9106
Publisher: Dove Medical Press
Start Page: 1125
End Page: 1134
Journal / Book Title: International Journal of Chronic Obstructive Pulmonary Disease
Volume: 13
Copyright Statement: © 2018 Vogelmeier et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (
Keywords: Science & Technology
Life Sciences & Biomedicine
Respiratory System
1102 Cardiovascular Medicine And Haematology
Publication Status: Published
Appears in Collections:National Heart and Lung Institute

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