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Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study

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Title: Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study
Authors: Anzueto, AR
Kostikas, K
Mezzi, K
Shen, S
Larbig, M
Patalano, F
Fogel, R
Banerji, D
Wedzicha, JA
Item Type: Journal Article
Abstract: Background Chronic obstructive pulmonary disease (COPD) is a progressive disease and a composite endpoint could be an indicator of treatment effect on disease worsening. This post-hoc analysis assessed whether indacaterol/glycopyrronium (IND/GLY) 110/50 μg once daily reduced the risk of clinically important deterioration (CID) versus salmeterol/fluticasone (SFC) 50/500 μg twice daily in moderate-to-very severe COPD patients from the FLAME study. Methods CID was defined as ≥100 mL decrease in forced expiratory volume in 1 s (FEV1) or ≥ 4-unit increase in St. George’s Respiratory Questionnaire (SGRQ) total score or a moderate-to-severe COPD exacerbation. Changes from baseline in the rate of moderate and severe exacerbations, time to first moderate-to-severe exacerbation, and change from baseline in the SGRQ score, measured after Week 12 up to Week 52, were assessed by presence of early CID (CID+) or absence of CID (CID−) at Week 12. Results IND/GLY significantly delayed the time to CID (hazard ratio [HR] (95% confidence interval [CI]), 0.72 [0.67–0.78]; P < 0.0001), and reduced the incidences of CID versus SFC. Additionally, IND/GLY delayed the time to CID in all patient subgroups. After 12 weeks until 52 weeks, CID+ patients had a significantly higher rate of moderate-to-severe exacerbations versus CID− patients (P < 0.0001); moreover, CID+ patients experienced moderate-to-severe exacerbations significantly earlier versus CID− patients (P < 0.0001). CID+ patients had a comparable change in the SGRQ total score versus CID− patients. Conclusions IND/GLY reduced the risk of CID versus SFC. CID had a significant impact on long-term exacerbation outcomes in patients with moderate-to-very severe COPD and a history of ≥1 exacerbations in the previous year.
Issue Date: 20-Jun-2018
Date of Acceptance: 13-Jun-2018
URI: http://hdl.handle.net/10044/1/61460
DOI: https://dx.doi.org/10.1186/s12931-018-0830-z
ISSN: 1465-9921
Publisher: BioMed Central
Journal / Book Title: Respiratory Research
Volume: 19
Copyright Statement: © The Author(s). 2018. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/ ), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated.
Keywords: Science & Technology
Life Sciences & Biomedicine
Respiratory System
Chronic obstructive pulmonary disease
COPD
Clinically important deterioration
CID
Indacaterol/glycopyrronium
Salmeterol/fluticasone
LABA/LAMA
FLAME
OBSTRUCTIVE PULMONARY-DISEASE
COMPOSITE END-POINTS
3 RANDOMIZED-TRIALS
SALMETEROL-FLUTICASONE
PROGNOSTIC ASSESSMENT
POOLED ANALYSIS
PARALLEL-GROUP
LUNG-FUNCTION
DOUBLE-BLIND
BODE INDEX
1102 Cardiovascular Medicine And Haematology
1103 Clinical Sciences
Publication Status: Published
Article Number: ARTN 121
Appears in Collections:National Heart and Lung Institute
Airway Disease
Faculty of Medicine



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