Abstract
BackgroundProspective 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.MethodsThe 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 62.5/25 μg once-daily, umeclidinium 62.5 μg once-daily or salmeterol 50 μg twice-daily. The primary endpoint was trough forced expiratory volume in 1 s (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.ResultsChange from baseline in trough FEV1 at Week 24 was 66 mL (95% confidence interval [CI]: 43, 89) and 141 mL (95% CI: 118, 164) greater with umeclidinium/vilanterol versus umeclidinium and salmeterol, respectively (both p < 0.001). 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], p = 0.018; vs salmeterol: 0.45 [95% CI: 0.15, 0.76], p = 0.004) 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% [p < 0.01]) and salmeterol (by 26–41% [p < 0.001]). Safety profiles were similar between treatments.ConclusionsUmeclidinium/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.
Highlights
Prospective evidence is lacking regarding incremental benefits of long-acting dual- versus monobronchodilation 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
long-acting muscarinic antagonists (LAMAs)/Long-acting β2-agonists (LABAs) therapy is more effective than LAMA or LABA monotherapy for improving lung function in patients with COPD; variability exists across studies in the reported magnitude of improvements of symptoms and health status with dual bronchodilation [2,3,4,5,6,7,8]
Concurrent use or recent withdrawal of inhaled corticosteroids (ICS) may limit the generalisability of the results of such bronchodilator studies and confound the results regarding the incremental benefits of LAMA/LABAs compared with mono-bronchodilator therapies [11, 12]
Summary
Prospective evidence is lacking regarding incremental benefits of long-acting dual- versus monobronchodilation 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. LAMA/LABA therapy is more effective than LAMA or LABA monotherapy for improving lung function in patients with COPD; variability exists across studies in the reported magnitude of improvements of symptoms and health status with dual bronchodilation [2,3,4,5,6,7,8]. Trials comparing dual- versus mono-bronchodilator therapy have generally included large proportions of patients with predominantly low exacerbation risk, but who were using concurrent inhaled corticosteroids (ICS) [2, 5, 9, 10]. Further trials of UMEC/VI versus mono-bronchodilator therapy in symptomatic patients not receiving concurrent ICS are warranted to prospectively assess treatment optimisation in this patient population
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