Dual bronchodilator therapy as first-line treatment in maintenance-naïve patients with symptomatic copd : A pre-specified analysis of the emax trial
(2021) In International Journal of COPD 16. p.1939-1956- Abstract
Introduction: Limited prospective evidence is available to guide selection of first-line maintenance therapy in patients with COPD. This pre-specified analysis of the EMAX trial explored the efficacy and safety of dual-versus mono-bronchodilator therapy in maintenance-naïve and maintenance-treated patients. Methods: The 24-week EMAX trial evaluated lung function, symptoms (including rescue medication use), exacerbations, and safety with umeclidinium/vilanterol, umeclidinium, and salmeterol in symptomatic patients at low exacerbation risk who were not receiving inhaled corticosteroids. Maintenance-naïve and maintenance-treated subgroups were defined by maintenance bronchodilator use 30 days before screening. Results: The analysis... (More)
Introduction: Limited prospective evidence is available to guide selection of first-line maintenance therapy in patients with COPD. This pre-specified analysis of the EMAX trial explored the efficacy and safety of dual-versus mono-bronchodilator therapy in maintenance-naïve and maintenance-treated patients. Methods: The 24-week EMAX trial evaluated lung function, symptoms (including rescue medication use), exacerbations, and safety with umeclidinium/vilanterol, umeclidinium, and salmeterol in symptomatic patients at low exacerbation risk who were not receiving inhaled corticosteroids. Maintenance-naïve and maintenance-treated subgroups were defined by maintenance bronchodilator use 30 days before screening. Results: The analysis included 749 (31%) maintenance-naïve and 1676 (69%) maintenance-treated patients. For both subgroups, improvements from baseline in trough FEV1 at Week 24 (primary endpoint) were greater with umeclidinium/vilanterol versus umeclidinium (mean difference [95% CI]; maintenance-naïve: 44 mL [1, 87]; maintenance-treated: 77 mL [50, 104]), and salmeterol (maintenance-naïve: 128 mL [85, 171]; maintenance-treated: 145 mL [118, 172]), and in rescue medication inhalations/day over 24 weeks versus umeclidinium (maintenance-naïve: −0.44 [−0.73, −0.16]; maintenance-treated: −0.28 [−0.45, −0.12]) and salmeterol (maintenance-naïve: −0.37 [−0.66, −0.09]; maintenance-treated: −0.25 [−0.41, −0.08]). In maintenance-naïve patients, umeclidinium/vilanterol numerically improved scores at Week 24 for Transition Dyspnea Index versus umeclidinium (0.37 [−0.21, 0.96]) and versus salmeterol (0.47 [−0.10, 1.05]) and Evaluating Respiratory Symptoms–COPD versus umeclidinium (−0.26 [−1.04, 0.53]) and versus salmeterol (−0.58 [−1.36, 0.20]), with similar improvements seen in maintenance-treated patients. All treatments were well tolerated across both subgroups. Conclusion: Similar to maintenance-treated patients, maintenance-naïve patients receiving umeclidinium/vilanterol showed greater improvements in lung function and symptoms com-pared with patients receiving umeclidinium or salmeterol. These findings provide support for the consideration of dual bronchodilator treatment in symptomatic maintenance-naïve patients with COPD.
(Less)
- author
- Bjermer, Leif LU ; Boucot, Isabelle H. ; Maltais, François ; Kerwin, Edward M. ; Naya, Ian P. ; Tombs, Lee ; Jones, Paul W. ; Compton, Chris ; Lipson, David A. and Vogelmeier, Claus F.
- organization
- publishing date
- 2021
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- COPD treatment, First-line therapy, Maintenance-naïve, Salmeterol, Umeclidinium, Umeclidinium/vilanterol
- in
- International Journal of COPD
- volume
- 16
- pages
- 18 pages
- publisher
- Dove Medical Press Ltd.
- external identifiers
-
- pmid:34234425
- scopus:85109327677
- ISSN
- 1176-9106
- DOI
- 10.2147/COPD.S291751
- language
- English
- LU publication?
- yes
- id
- 2f99491f-9a08-468f-aea7-854f12509e1d
- date added to LUP
- 2021-08-12 12:23:21
- date last changed
- 2024-04-06 06:38:09
@article{2f99491f-9a08-468f-aea7-854f12509e1d,
abstract = {{<p>Introduction: Limited prospective evidence is available to guide selection of first-line maintenance therapy in patients with COPD. This pre-specified analysis of the EMAX trial explored the efficacy and safety of dual-versus mono-bronchodilator therapy in maintenance-naïve and maintenance-treated patients. Methods: The 24-week EMAX trial evaluated lung function, symptoms (including rescue medication use), exacerbations, and safety with umeclidinium/vilanterol, umeclidinium, and salmeterol in symptomatic patients at low exacerbation risk who were not receiving inhaled corticosteroids. Maintenance-naïve and maintenance-treated subgroups were defined by maintenance bronchodilator use 30 days before screening. Results: The analysis included 749 (31%) maintenance-naïve and 1676 (69%) maintenance-treated patients. For both subgroups, improvements from baseline in trough FEV<sub>1</sub> at Week 24 (primary endpoint) were greater with umeclidinium/vilanterol versus umeclidinium (mean difference [95% CI]; maintenance-naïve: 44 mL [1, 87]; maintenance-treated: 77 mL [50, 104]), and salmeterol (maintenance-naïve: 128 mL [85, 171]; maintenance-treated: 145 mL [118, 172]), and in rescue medication inhalations/day over 24 weeks versus umeclidinium (maintenance-naïve: −0.44 [−0.73, −0.16]; maintenance-treated: −0.28 [−0.45, −0.12]) and salmeterol (maintenance-naïve: −0.37 [−0.66, −0.09]; maintenance-treated: −0.25 [−0.41, −0.08]). In maintenance-naïve patients, umeclidinium/vilanterol numerically improved scores at Week 24 for Transition Dyspnea Index versus umeclidinium (0.37 [−0.21, 0.96]) and versus salmeterol (0.47 [−0.10, 1.05]) and Evaluating Respiratory Symptoms–COPD versus umeclidinium (−0.26 [−1.04, 0.53]) and versus salmeterol (−0.58 [−1.36, 0.20]), with similar improvements seen in maintenance-treated patients. All treatments were well tolerated across both subgroups. Conclusion: Similar to maintenance-treated patients, maintenance-naïve patients receiving umeclidinium/vilanterol showed greater improvements in lung function and symptoms com-pared with patients receiving umeclidinium or salmeterol. These findings provide support for the consideration of dual bronchodilator treatment in symptomatic maintenance-naïve patients with COPD.</p>}},
author = {{Bjermer, Leif and Boucot, Isabelle H. and Maltais, François and Kerwin, Edward M. and Naya, Ian P. and Tombs, Lee and Jones, Paul W. and Compton, Chris and Lipson, David A. and Vogelmeier, Claus F.}},
issn = {{1176-9106}},
keywords = {{COPD treatment; First-line therapy; Maintenance-naïve; Salmeterol; Umeclidinium; Umeclidinium/vilanterol}},
language = {{eng}},
pages = {{1939--1956}},
publisher = {{Dove Medical Press Ltd.}},
series = {{International Journal of COPD}},
title = {{Dual bronchodilator therapy as first-line treatment in maintenance-naïve patients with symptomatic copd : A pre-specified analysis of the emax trial}},
url = {{http://dx.doi.org/10.2147/COPD.S291751}},
doi = {{10.2147/COPD.S291751}},
volume = {{16}},
year = {{2021}},
}