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Early and sustained symptom improvement with umeclidinium/vilanterol versus monotherapy in COPD: a post hoc analysis of the EMAX randomised controlled trial
| Content Provider | SAGE Publishing |
|---|---|
| Author | Kerwin, Edward M. Boucot, Isabelle H. Vogelmeier, Claus F. Maltais, Francois Naya, Ian P. Tombs, Lee Jones, Paul W. Lipson, David A. Keeley, Tom Bjermer, Leif |
| Copyright Year | 2020 |
| Abstract | In chronic obstructive pulmonary disease (COPD), both the time needed for patients to gain symptom improvement with long-acting bronchodilator therapy and whether an early response is predictive of a sustained response is unknown. This study aimed to investigate how quickly meaningful symptom responses are seen in patients with COPD with bronchodilator therapy and whether these responses are sustained.Methods:Early MAXimisation of bronchodilation for improving COPD stability (EMAX) was a 24-week, double-blind, double-dummy, parallel-group trial that randomised patients to umeclidinium/vilanterol (UMEC/VI), umeclidinium or salmeterol. Daily Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score and rescue salbutamol use were captured via an electronic diary and analysed initially in 4-weekly periods. Post hoc analyses assessed change from baseline in daily E-RS:COPD score and rescue medication use weekly (Weeks 1–8), and association between E-RS:COPD responder status at Weeks 1–4 and later time points.Results:In the intent-to-treat population (n = 2425), reductions from baseline in E-RS:COPD scores and rescue medication use were apparent from Day 2 with all treatments. Treatment differences for UMEC/VI versus either monotherapy plateaued by Week 4–8 and were sustained at Weeks 21–24; improvements were consistently greater with UMEC/VI. For all treatments, most patients (60–85%) retained their Weeks 1–4 E-RS:COPD responder/non-responder status at Weeks 21−24. Among patients receiving UMEC/VI who were E-RS:COPD responders at Weeks 1–4, 70% were responders at Weeks 21–24.Conclusion:Patients with symptomatic COPD had greater potential for early symptom improvements with UMEC/VI versus either monotherapy. This benefit was generally maintained for 24 weeks. Early monitoring of treatment response can provide clinicians with an early indication of a patient’s likely longer-term response to prescribed bronchodilator treatment and will facilitate appropriate early adjustments in care.Clinical Trial Registration:NCT03034915, 2016-002513-22 (EudraCT Number).The reviews of this paper are available via the supplemental material section. |
| Related Links | https://journals.sagepub.com/doi/pdf/10.1177/1753466620926949?download=true |
| ISSN | 17534666 |
| Volume Number | 14 |
| Journal | Therapeutic Advances in Respiratory Disease (TAR) |
| e-ISSN | 17534666 |
| DOI | 10.1177/1753466620926949 |
| Language | English |
| Publisher | Sage Publications UK |
| Publisher Date | 2020-05-28 |
| Publisher Place | London |
| Access Restriction | Open |
| Rights Holder | © The Author(s), 2020 |
| Subject Keyword | COPD rescue medication bronchodilator therapy symptoms E-RS:COPD |
| Content Type | Text |
| Resource Type | Article |
| Subject | Pulmonary and Respiratory Medicine Pharmacology (medical) |