Wtreatment of copd with long-acting bronchodilators : Association between early and longer-term clinically important improvement
(2021) In International Journal of COPD 16. p.1215-1226- Abstract
Introduction: This post hoc analysis of the “Early MAXimization of bronchodilation for improving COPD stability” (EMAX) trial investigated whether patients achieving early clinically important improvement (CII) sustained longer-term improvements and lower risk of clinically important deterioration (CID). Methods: Patients were randomized to umeclidinium/vilanterol, umeclidinium, or salmeterol for 24 weeks. The patient-reported outcomes (PROs) Transition Dyspnea Index (TDI), Evaluating Respiratory Symptoms, St George’s Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) were assessed. CII, defined as attaining minimum clinically important differences (MCID) in ≥2 PROs, was assessed at Weeks 4, 12 and 24. CID was defined as a... (More)
Introduction: This post hoc analysis of the “Early MAXimization of bronchodilation for improving COPD stability” (EMAX) trial investigated whether patients achieving early clinically important improvement (CII) sustained longer-term improvements and lower risk of clinically important deterioration (CID). Methods: Patients were randomized to umeclidinium/vilanterol, umeclidinium, or salmeterol for 24 weeks. The patient-reported outcomes (PROs) Transition Dyspnea Index (TDI), Evaluating Respiratory Symptoms, St George’s Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) were assessed. CII, defined as attaining minimum clinically important differences (MCID) in ≥2 PROs, was assessed at Weeks 4, 12 and 24. CID was defined as a deterioration in CAT, SGRQ, TDI by the MCID and/or a moderate/severe exacerbation from Day 30. Results: Of 2425 patients, 50%, 53% and 51% achieved a CII at Weeks 4, 12 and 24, respectively. Patients with a CII at Week 4 versus those without had significantly greater odds of achieving a CII at Weeks 12 and 24 (odds ratio: 5.57 [95% CI: 4.66, 6.66]; 4.09 [95% CI: 3.44, 4.86]). The risk of a CID was higher in patients who did not achieve a CII at Week 4 compared with patients who did (hazard ratio [95% CI]: 2.09 [1.86, 2.34]). Patients treated with umeclidinium/vilanterol versus either monotherapy had significantly greater odds of achieving CII at Weeks 4, 12 and 24. Conclusion: Achieving a CII at Week 4 was associated with longer-term improvement in PROs and a reduced risk of deterioration. Further research is required to investigate the importance of an early response to treatment on the long-term disease course.
(Less)
- author
- Vogelmeier, Claus F. ; Naya, Ian P. ; Maltais, François ; Bjermer, Leif LU ; Kerwin, Edward M. ; Tombs, Lee ; Jones, Paul W. ; Compton, Chris ; Lipson, David A. and Boucot, Isabelle H.
- organization
- publishing date
- 2021
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Bronchodilator, Clinically important deterioration, Clinically important improvement, COPD symptoms, Early improvement, Patient-reported outcomes
- in
- International Journal of COPD
- volume
- 16
- pages
- 12 pages
- publisher
- Dove Medical Press Ltd.
- external identifiers
-
- scopus:85105766735
- pmid:33976543
- ISSN
- 1176-9106
- DOI
- 10.2147/COPD.S295835
- language
- English
- LU publication?
- yes
- additional info
- Funding Information: Editorial support (in the form of writing assistance, assembling figures, collating author comments, grammatical editing, and referencing) was provided by Katie White, PhD, and Liam Campbell, PhD, of Fishawack Indicia Ltd, UK, part of Fishawack Health, and was funded by GSK. ELLIPT A and DISKUS are owned by/licensed to the GSK group of companies. Funding Information: This study was funded by GlaxoSmithKline (GSK study 201749; NCT03034915). Funding Information: CFV has received grants from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Grifols, Mundipharma, Novartis, and the German Federal Ministry of Education and Research (BMBF) Competence Network Asthma and COPD (ASCONET), and has received personal fees from AstraZeneca, Boehringer Ingelheim, Berlin Chemie/ Menarini, Chiesi, CSL Behring, GSK, Grifols, MedUpdate, Nuvaira, Novartis and T eva. EMK has served on advisory boards, speaker panels or received travel reimbursement for Amphastar , AstraZeneca, Boehringer Ingelheim, GSK, Mylan, Novartis, Pearl, Sunovion, T eva and Theravance, and has received consulting fees from Cipla, Connect Biopharma, and GSK. IHB, DAL, CC
- id
- 78a6d3a0-38bb-49ae-8b62-19c360ccf699
- date added to LUP
- 2021-05-27 12:43:38
- date last changed
- 2024-06-15 11:34:22
@article{78a6d3a0-38bb-49ae-8b62-19c360ccf699,
abstract = {{<p>Introduction: This post hoc analysis of the “Early MAXimization of bronchodilation for improving COPD stability” (EMAX) trial investigated whether patients achieving early clinically important improvement (CII) sustained longer-term improvements and lower risk of clinically important deterioration (CID). Methods: Patients were randomized to umeclidinium/vilanterol, umeclidinium, or salmeterol for 24 weeks. The patient-reported outcomes (PROs) Transition Dyspnea Index (TDI), Evaluating Respiratory Symptoms, St George’s Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) were assessed. CII, defined as attaining minimum clinically important differences (MCID) in ≥2 PROs, was assessed at Weeks 4, 12 and 24. CID was defined as a deterioration in CAT, SGRQ, TDI by the MCID and/or a moderate/severe exacerbation from Day 30. Results: Of 2425 patients, 50%, 53% and 51% achieved a CII at Weeks 4, 12 and 24, respectively. Patients with a CII at Week 4 versus those without had significantly greater odds of achieving a CII at Weeks 12 and 24 (odds ratio: 5.57 [95% CI: 4.66, 6.66]; 4.09 [95% CI: 3.44, 4.86]). The risk of a CID was higher in patients who did not achieve a CII at Week 4 compared with patients who did (hazard ratio [95% CI]: 2.09 [1.86, 2.34]). Patients treated with umeclidinium/vilanterol versus either monotherapy had significantly greater odds of achieving CII at Weeks 4, 12 and 24. Conclusion: Achieving a CII at Week 4 was associated with longer-term improvement in PROs and a reduced risk of deterioration. Further research is required to investigate the importance of an early response to treatment on the long-term disease course.</p>}},
author = {{Vogelmeier, Claus F. and Naya, Ian P. and Maltais, François and Bjermer, Leif and Kerwin, Edward M. and Tombs, Lee and Jones, Paul W. and Compton, Chris and Lipson, David A. and Boucot, Isabelle H.}},
issn = {{1176-9106}},
keywords = {{Bronchodilator; Clinically important deterioration; Clinically important improvement; COPD symptoms; Early improvement; Patient-reported outcomes}},
language = {{eng}},
pages = {{1215--1226}},
publisher = {{Dove Medical Press Ltd.}},
series = {{International Journal of COPD}},
title = {{Wtreatment of copd with long-acting bronchodilators : Association between early and longer-term clinically important improvement}},
url = {{http://dx.doi.org/10.2147/COPD.S295835}},
doi = {{10.2147/COPD.S295835}},
volume = {{16}},
year = {{2021}},
}