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HERO ID
8496628
Reference Type
Journal Article
Title
Efficacy of umeclidinium/vilanterol versus umeclidinium and salmeterol monotherapies in symptomatic patients with COPD not receiving inhaled corticosteroids: the EMAX randomised trial
Author(s)
Maltais, F; Bjermer, L; Kerwin, EM; Jones, PW; Watkins, ML; Tombs, L; Naya, IP; Boucot, IH; Lipson, DA; Compton, C; Vahdati-Bolouri, M; Vogelmeier, CF
Year
2019
Is Peer Reviewed?
1
Journal
Respiratory Research
ISSN:
1465-9921
EISSN:
1465-993X
Publisher
NLM (Medline)
Volume
20
Issue
1
Page Numbers
238
Language
English
DOI
10.1186/s12931-019-1193-9
Abstract
BACKGROUND: Prospective evidence is lacking regarding incremental benefits of long-acting dual- versus mono-bronchodilation in improving symptoms and preventing short-term disease worsening/treatment failure in low exacerbation risk patients with chronic obstructive pulmonary disease (COPD) not receiving inhaled corticosteroids. METHODS: The 24-week, double-blind, double-dummy, parallel-group Early MAXimisation of bronchodilation for improving COPD stability (EMAX) trial randomised patients at low exacerbation risk not receiving inhaled corticosteroids, to umeclidinium/vilanterol 62.5/25âμg once-daily, umeclidinium 62.5âμg once-daily or salmeterol 50âμg twice-daily. The primary endpoint was trough forced expiratory volume in 1âs (FEV1) at Week 24. The study was also powered for the secondary endpoint of Transition Dyspnoea Index at Week 24. Other efficacy assessments included spirometry, symptoms, heath status and short-term disease worsening measured by the composite endpoint of clinically important deterioration using three definitions. RESULTS: Change from baseline in trough FEV1 at Week 24 was 66âmL (95% confidence interval [CI]: 43, 89) and 141âmL (95% CI: 118, 164) greater with umeclidinium/vilanterol versus umeclidinium and salmeterol, respectively (both pâ<â0.001). Umeclidinium/vilanterol demonstrated consistent improvements in Transition Dyspnoea Index versus both monotherapies at Week 24 (vs umeclidinium: 0.37 [95% CI: 0.06, 0.68], pâ=â0.018; vs salmeterol: 0.45 [95% CI: 0.15, 0.76], pâ=â0.004) and all other symptom measures at all time points. Regardless of the clinically important deterioration definition considered, umeclidinium/vilanterol significantly reduced the risk of a first clinically important deterioration compared with umeclidinium (by 16-25% [pâ<â0.01]) and salmeterol (by 26-41% [pâ<â0.001]). Safety profiles were similar between treatments. CONCLUSIONS: Umeclidinium/vilanterol consistently provides early and sustained improvements in lung function and symptoms and reduces the risk of deterioration/treatment failure versus umeclidinium or salmeterol in symptomatic patients with low exacerbation risk not receiving inhaled corticosteroids. These findings suggest a potential for early use of dual bronchodilators to help optimise therapy in this patient group.
Keywords
Bronchodilator therapy; Clinically important deterioration; COPD; Dyspnoea; Lung function
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