Therefore, the assessment of rescue medication use in patients with COPD is likely to be a useful measure of changes in symptom burden in clinical trials and routine clinical practice. In COPD clinical trials, reductions in daily SABA use (puffs/day) have also been shown to positively correlate with mean improvements in lung function, exacerbation rates and health-related quality of life. High supplementary SABA use is a marker of an increased risk of exacerbations and hospitalisation and is associated with significant economic costs. This suggests that patients with COPD who frequently use SABA may be inadequately treated with their current maintenance therapies. SABA use tends to increase with increasing COPD severity in patients who were receiving a single LAMA or LABA bronchodilator in routine US clinical practice, a mean SABA use of 3.3 puffs/day was reported in patients with less severe airflow limitation (≥50% predicted forced expiratory volume in 1 s ), compared with 5.2 puffs/day in patients with more severe airflow limitation (< 50% predicted FEV 1). Patients may use high levels of SABA for a number of reasons, including having poorly controlled COPD due to suboptimal prescribing of maintenance therapy, having a mild exacerbation, poor adherence or responsiveness to maintenance therapy, or a lack of access to appropriate therapy. An analysis of more than 23,000 patients from 23 clinical trials of mono- and dual- bronchodilators demonstrated that patients across a variety of COPD severities used approximately 4 SABA puffs/day. Some patients with chronic obstructive pulmonary disease (COPD) using long-acting muscarinic antagonists (LAMAs) or long-acting β 2-agonists (LABAs) also use frequent short-acting β 2-agonist (SABA) rescue therapy. SABA use may be a confounding factor in bronchodilator trials and in high SABA users changes in SABA use may be considered a robust symptom outcome. In high SABA users, there may be a smaller difference in treatment response between dual- and mono-bronchodilator therapy the reasons for this require further investigation. Fractional polynomial modelling showed baseline SABA use ≥4 puffs/day resulted in smaller incremental symptom improvements with umeclidinium/vilanterol versus umeclidinium compared with baseline SABA use < 4 puffs/day. Similar findings were observed when comparing umeclidinium/vilanterol and salmeterol. By contrast, significant reductions in mean SABA puffs/day with umeclidinium/vilanterol versus umeclidinium were observed only in high SABA users (high: − 0.56 low: − 0.10 ). Patients treated with umeclidinium/vilanterol versus umeclidinium demonstrated statistically significant improvements in trough FEV 1 at Week 24 in both SABA subgroups (59–74 mL p < 0.001) however, only low SABA users demonstrated significant improvements in TDI (high: 0.27 low: 0.49 ) and E-RS (high: 0.48 low: 0.60 ) scores. ResultsĪt baseline, patients in the high SABA use subgroup (mean: 3.91 puffs/day, n = 1212) had more severe airflow limitation, were more symptomatic and had worse health status versus patients in the low SABA use subgroup (0.39 puffs/day, n = 1206). A post hoc analysis used fractional polynomial modelling with continuous transformations of baseline SABA use covariates. Pre-specified subgroup analyses stratified patients by median baseline SABA use (low, < 1.5 puffs/day high, ≥1.5 puffs/day) to examine change from baseline in trough forced expiratory volume in 1 s (FEV 1), change in symptoms (Transition Dyspnoea Index, Evaluating Respiratory Symptoms-COPD ), daily SABA use and exacerbation risk. The Early MAXimisation of bronchodilation for improving COPD stability (EMAX) trial randomised symptomatic patients with low exacerbation risk not receiving inhaled corticosteroids 1:1:1 to once-daily umeclidinium/vilanterol 62.5/25 μg, once-daily umeclidinium 62.5 μg or twice-daily salmeterol 50 μg for 24 weeks. This analysis investigated whether SABA use impacts treatment differences between maintenance dual- and mono-bronchodilators in patients with COPD. Short-acting β 2-agonist (SABA) bronchodilators help alleviate symptoms in chronic obstructive pulmonary disease (COPD) and may be a useful marker of symptom severity.
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