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- Maltais, F.Laval University,Institut universitaire de cardiologie et de pneumologie de Québec (author)
Salbutamol use in relation to maintenance bronchodilator efficacy in COPD : a prospective subgroup analysis of the EMAX trial
- Article/chapterEnglish2020
Publisher, publication year, extent ...
- 2020-10-22
- Springer Science and Business Media LLC,2020
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- LIBRIS-ID:oai:lup.lub.lu.se:38f168f5-e957-4467-a022-ad3715cbe780
- https://lup.lub.lu.se/record/38f168f5-e957-4467-a022-ad3715cbe780URI
- https://doi.org/10.1186/s12931-020-01451-8DOI
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- Language:English
- Summary in:English
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- Background: Short-acting β2-agonist (SABA) bronchodilators help alleviate symptoms in chronic obstructive pulmonary disease (COPD) and may be a useful marker of symptom severity. This analysis investigated whether SABA use impacts treatment differences between maintenance dual- and mono-bronchodilators in patients with COPD. Methods: 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. 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 (FEV1), change in symptoms (Transition Dyspnoea Index [TDI], Evaluating Respiratory Symptoms-COPD [E-RS]), daily SABA use and exacerbation risk. A post hoc analysis used fractional polynomial modelling with continuous transformations of baseline SABA use covariates. Results: At 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). Patients treated with umeclidinium/vilanterol versus umeclidinium demonstrated statistically significant improvements in trough FEV1 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 [p = 0.241]; low: 0.49 [p = 0.025]) and E-RS (high: 0.48 [p = 0.138]; low: 0.60 [p = 0.034]) scores. By contrast, significant reductions in mean SABA puffs/day with umeclidinium/vilanterol versus umeclidinium were observed only in high SABA users (high: − 0.56 [p < 0.001]; low: − 0.10 [p = 0.132]). Similar findings were observed when comparing umeclidinium/vilanterol and salmeterol. 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. Conclusions: 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. 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. Funding: GlaxoSmithKline (study number 201749 [NCT03034915]).
Subject headings and genre
- MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Lungmedicin och allergi hsv//swe
- MEDICAL AND HEALTH SCIENCES Clinical Medicine Respiratory Medicine and Allergy hsv//eng
- (3–10): dual bronchodilators
- COPD
- Lung function
- Rescue therapy
- SABA
- Salbutamol
- Symptoms
Added entries (persons, corporate bodies, meetings, titles ...)
- Naya, I. P.RAMAX Ltd,SmithKline Beecham Pharmaceuticals (author)
- Vogelmeier, C. F.University Hospital Giessen and Marburg,Philipp University of Marburg (author)
- Boucot, I. H.SmithKline Beecham Pharmaceuticals (author)
- Jones, P. W.SmithKline Beecham Pharmaceuticals (author)
- Bjermer, L.Lund University,Lunds universitet,Klinisk lungmedicin,Forskargrupper vid Lunds universitet,Clinical Respiratory Medicine,Lund University Research Groups(Swepub:lu)lung-lbj (author)
- Tombs, L.SmithKline Beecham Pharmaceuticals (author)
- Compton, C.SmithKline Beecham Pharmaceuticals (author)
- Lipson, D. A.GlaxoSmithKline,University of Pennsylvania (author)
- Kerwin, E. M.Clinical Research Institute of Southern Oregon (author)
- Laval UniversityInstitut universitaire de cardiologie et de pneumologie de Québec (creator_code:org_t)
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- In:Respiratory Research: Springer Science and Business Media LLC21:11465-99211465-993X
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