Patients not receiving ICS treatment are an important and prevalent category of patients and usually reflect earlier stages of COPD. That study demonstrated improvements in lung function and rescue medication use with UMEC/VI versus both monotherapies but did not demonstrate any incremental improvements in self-reported breathlessness or other patient-reported outcomes (PROs). In the only 24-week Phase III RCT comparing the LAMA/LABA umeclidinium/vilanterol (UMEC/VI) versus UMEC and VI monotherapy, half of the patients continued using concurrent ICS. A recent integrated analysis of 23 randomised controlled trials (RCTs n = 23,213) evaluating the effect of LAMA/LABAs versus LAMAs, LABAs or placebo, on lung function, symptoms and exacerbation rates reported that 54% of enrolled patients were using concurrent ICS. Concurrent use or recent withdrawal of 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. Until now, trials comparing dual- versus mono-bronchodilator therapy have generally included large proportions of patients with predominantly low exacerbation risk, but who were nevertheless using concurrent inhaled corticosteroids (ICS). LAMA/LABA therapy is more effective than LAMA or LABA monotherapy for improving lung function in patients with COPD however, variability exists across studies in the reported magnitude of improvements of symptoms and health status with dual bronchodilation. LAMA/LABA dual therapy is also considered appropriate initial therapy in patients who experience severe breathlessness however, based on current evidence, a stepwise approach is generally preferred. The recommended first-line treatment for patients with symptomatic COPD at low exacerbation risk is LAMA or LABA monotherapy. ![]() Long-acting bronchodilators, including long-acting muscarinic antagonists (LAMAs) and long-acting β 2-agonists (LABAs), form the basis of maintenance therapy in chronic obstructive pulmonary disease (COPD). ![]() These findings suggest a potential for early use of dual bronchodilators to help optimise therapy in this patient group. 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. Safety profiles were similar between treatments. 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% ) and salmeterol (by 26–41% ). Umeclidinium/vilanterol demonstrated consistent improvements in Transition Dyspnoea Index versus both monotherapies at Week 24 (vs umeclidinium: 0.37, p = 0.018 vs salmeterol: 0.45, p = 0.004) and all other symptom measures at all time points. ResultsĬhange from baseline in trough FEV 1 at Week 24 was 66 mL (95% confidence interval : 43, 89) and 141 mL (95% CI: 118, 164) greater with umeclidinium/vilanterol versus umeclidinium and salmeterol, respectively (both p < 0.001). 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. ![]() The study was also powered for the secondary endpoint of Transition Dyspnoea Index at Week 24. The primary endpoint was trough forced expiratory volume in 1 s (FEV 1) at Week 24. 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 62.5/25 μg once-daily, umeclidinium 62.5 μg once-daily or salmeterol 50 μg twice-daily. 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.
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