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Salbutamol use in r...
Salbutamol use in relation to maintenance bronchodilator efficacy in COPD : a prospective subgroup analysis of the EMAX trial
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- Maltais, F. (author)
- Laval University,Institut universitaire de cardiologie et de pneumologie de Québec
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- Naya, I. P. (author)
- RAMAX Ltd,SmithKline Beecham Pharmaceuticals
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- Vogelmeier, C. F. (author)
- University Hospital Giessen and Marburg,Philipp University of Marburg
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- Boucot, I. H. (author)
- SmithKline Beecham Pharmaceuticals
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- Jones, P. W. (author)
- SmithKline Beecham Pharmaceuticals
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- Bjermer, L. (author)
- Lund University,Lunds universitet,Klinisk lungmedicin,Forskargrupper vid Lunds universitet,Clinical Respiratory Medicine,Lund University Research Groups
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- Tombs, L. (author)
- SmithKline Beecham Pharmaceuticals
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- Compton, C. (author)
- SmithKline Beecham Pharmaceuticals
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- Lipson, D. A. (author)
- GlaxoSmithKline,University of Pennsylvania
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- Kerwin, E. M. (author)
- Clinical Research Institute of Southern Oregon
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(creator_code:org_t)
- 2020-10-22
- 2020
- English.
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In: Respiratory Research. - : Springer Science and Business Media LLC. - 1465-9921 .- 1465-993X. ; 21:1
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Abstract
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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
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Lungmedicin och allergi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Respiratory Medicine and Allergy (hsv//eng)
Keyword
- (3–10): dual bronchodilators
- COPD
- Lung function
- Rescue therapy
- SABA
- Salbutamol
- Symptoms
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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Maltais, F.
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Naya, I. P.
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Vogelmeier, C. F ...
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Boucot, I. H.
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Jones, P. W.
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Bjermer, L.
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show more...
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Tombs, L.
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Compton, C.
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Lipson, D. A.
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Kerwin, E. M.
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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Respiratory Rese ...
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Lund University