PMID- 33976543
OWN - NLM
STAT- MEDLINE
DCOM- 20210727
LR  - 20220422
IS  - 1178-2005 (Electronic)
IS  - 1176-9106 (Print)
IS  - 1176-9106 (Linking)
VI  - 16
DP  - 2021
TI  - Treatment of COPD with Long-Acting Bronchodilators: Association Between Early and 
      Longer-Term Clinically Important Improvement.
PG  - 1215-1226
LID - 10.2147/COPD.S295835 [doi]
AB  - 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.
CI  - (c) 2021 Vogelmeier et al.
FAU - Vogelmeier, Claus F
AU  - Vogelmeier CF
AD  - Department of Medicine, Pulmonary and Critical Care Medicine, University Medical 
      Center Giessen and Marburg, Philipps-Universitat Marburg, Member of the German 
      Center for Lung Research (DZL), Marburg, Germany.
FAU - Naya, Ian P
AU  - Naya IP
AD  - Global Specialty & Primary Care, GSK, Brentford, Middlesex, UK.
AD  - RAMAX Ltd, Bramhall, Cheshire, UK.
FAU - Maltais, Francois
AU  - Maltais F
AUID- ORCID: 0000-0002-6809-4651
AD  - Centre De Pneumologie, Institut Universitaire De Cardiologie Et De Pneumologie De 
      Quebec, Universite Laval, Quebec, Canada.
FAU - Bjermer, Leif
AU  - Bjermer L
AUID- ORCID: 0000-0002-3441-8099
AD  - Respiratory Medicine and Allergology, Lund University, Lund, Sweden.
FAU - Kerwin, Edward M
AU  - Kerwin EM
AUID- ORCID: 0000-0002-1697-9036
AD  - Altitude Clinical Consulting and Clinical Research Institute of Southern Oregon, 
      Medford, OR, USA.
FAU - Tombs, Lee
AU  - Tombs L
AD  - Precise Approach Ltd, Contingent Worker on Assignment at GSK, Brentford, 
      Middlesex, UK.
FAU - Jones, Paul W
AU  - Jones PW
AUID- ORCID: 0000-0001-6087-9182
AD  - Global Specialty & Primary Care, GSK, Brentford, Middlesex, UK.
FAU - Compton, Chris
AU  - Compton C
AD  - Global Specialty & Primary Care, GSK, Brentford, Middlesex, UK.
FAU - Lipson, David A
AU  - Lipson DA
AUID- ORCID: 0000-0001-6732-4593
AD  - Respiratory Clinical Sciences, GSK, Collegeville, PA, USA.
AD  - Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
FAU - Boucot, Isabelle H
AU  - Boucot IH
AUID- ORCID: 0000-0003-0410-4969
AD  - Global Specialty & Primary Care, GSK, Brentford, Middlesex, UK.
AD  - Medical Emerging Markets, GSK, Brentford, Middlesex, UK.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210503
PL  - New Zealand
TA  - Int J Chron Obstruct Pulmon Dis
JT  - International journal of chronic obstructive pulmonary disease
JID - 101273481
RN  - 0 (Bronchodilator Agents)
RN  - 6EW8Q962A5 (Salmeterol Xinafoate)
SB  - IM
MH  - *Bronchodilator Agents/therapeutic use
MH  - Forced Expiratory Volume
MH  - Humans
MH  - *Pulmonary Disease, Chronic Obstructive/diagnosis/drug therapy
MH  - Salmeterol Xinafoate/therapeutic use
MH  - Treatment Outcome
PMC - PMC8106450
OTO - NOTNLM
OT  - COPD symptoms
OT  - bronchodilator
OT  - clinically important deterioration
OT  - clinically important improvement
OT  - early improvement
OT  - patient-reported outcomes
COIS- 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 Teva. EMK has 
      served on advisory boards, speaker panels or received travel reimbursement for 
      Amphastar, AstraZeneca, Boehringer Ingelheim, GSK, Mylan, Novartis, Pearl, 
      Sunovion, Teva and Theravance, and has received consulting fees from Cipla, 
      Connect Biopharma, and GSK. IHB, DAL, CC and PWJ are employees of GSK and hold 
      stock and shares in GSK. FM has received research grants for participating in 
      multicenter trials for AstraZeneca, Boehringer Ingelheim, GSK, Sanofi and 
      Novartis, and has received unrestricted research grants and personal fees from 
      Boehringer Ingelheim, Grifols and Novartis. FM also reports financial 
      participation in Oxynov, a company which is developing an oxygen delivery system. 
      IPN was an employee of GSK at the time of the study, holds stocks and shares in 
      GSK, and was a contingent worker on assignment at AstraZeneca. LT is a contingent 
      worker on assignment at GSK. LB has received honoraria for giving a lecture or 
      attending an advisory board for Airsonett, ALK-Abello, AstraZeneca, Boehringer 
      Ingelheim, Chiesi, GSK, Meda, Novartis and Teva. The authors report no other 
      conflicts of interest in this work.
EDAT- 2021/05/13 06:00
MHDA- 2021/07/28 06:00
PMCR- 2021/05/03
CRDT- 2021/05/12 07:01
PHST- 2020/12/04 00:00 [received]
PHST- 2021/03/22 00:00 [accepted]
PHST- 2021/05/12 07:01 [entrez]
PHST- 2021/05/13 06:00 [pubmed]
PHST- 2021/07/28 06:00 [medline]
PHST- 2021/05/03 00:00 [pmc-release]
AID - 295835 [pii]
AID - 10.2147/COPD.S295835 [doi]
PST - epublish
SO  - Int J Chron Obstruct Pulmon Dis. 2021 May 3;16:1215-1226. doi: 
      10.2147/COPD.S295835. eCollection 2021.