Efficacy and safety of revefenacin for nebulization in patients with chronic obstructive pulmonary disease taking concomitant ICS/LABA or LABA: subgroup analysis from phase III trials.
Administration, Inhalation
Adrenal Cortex Hormones
/ administration & dosage
Adrenergic beta-Agonists
/ administration & dosage
Aged
Benzamides
/ administration & dosage
Bronchodilator Agents
/ administration & dosage
Carbamates
/ administration & dosage
Clinical Trials, Phase III as Topic
Drug Administration Schedule
Drug Therapy, Combination
Female
Forced Expiratory Volume
Humans
Lung
/ drug effects
Male
Middle Aged
Muscarinic Antagonists
/ administration & dosage
Nebulizers and Vaporizers
Pulmonary Disease, Chronic Obstructive
/ diagnosis
Randomized Controlled Trials as Topic
Recovery of Function
Time Factors
Treatment Outcome
long-acting muscarinic receptor antagonist
nebulization
triple therapy
Journal
Therapeutic advances in respiratory disease
ISSN: 1753-4666
Titre abrégé: Ther Adv Respir Dis
Pays: England
ID NLM: 101316317
Informations de publication
Date de publication:
Historique:
entrez:
29
2
2020
pubmed:
29
2
2020
medline:
2
6
2021
Statut:
ppublish
Résumé
Combinations of a long-acting muscarinic receptor antagonist (LAMA), long-acting β-agonist (LABA), and inhaled corticosteroid (ICS) are used for patients with persistent chronic obstructive pulmonary disease (COPD) exacerbations on bronchodilator monotherapy. In this prespecified subgroup analysis, we assessed the efficacy and safety of the LAMA revefenacin in patients with COPD taking concomitant LABA, including ICS/LABA (LABA subgroup). Efficacy data were obtained from two 12-week, replicate, placebo-controlled trials and safety data were pooled from the 12-week and a 52-week tiotropium-controlled trial. Patients received revefenacin 175 µg or placebo in the 12-week or tiotropium 18 µg in the 52-week studies. The efficacy endpoint was least squares (LS) mean change from baseline in trough forced expiratory volume in 1 second (FEV Revefenacin produced similar improvements from baseline in trough FEV Once daily revefenacin for nebulization can be an effective and well-tolerated treatment for patients who require concomitant use of LABA with or without ICS. NCT02512510, NCT02459080, NCT02518139
Sections du résumé
BACKGROUND
Combinations of a long-acting muscarinic receptor antagonist (LAMA), long-acting β-agonist (LABA), and inhaled corticosteroid (ICS) are used for patients with persistent chronic obstructive pulmonary disease (COPD) exacerbations on bronchodilator monotherapy. In this prespecified subgroup analysis, we assessed the efficacy and safety of the LAMA revefenacin in patients with COPD taking concomitant LABA, including ICS/LABA (LABA subgroup).
METHODS
Efficacy data were obtained from two 12-week, replicate, placebo-controlled trials and safety data were pooled from the 12-week and a 52-week tiotropium-controlled trial. Patients received revefenacin 175 µg or placebo in the 12-week or tiotropium 18 µg in the 52-week studies. The efficacy endpoint was least squares (LS) mean change from baseline in trough forced expiratory volume in 1 second (FEV
RESULTS
Revefenacin produced similar improvements from baseline in trough FEV
CONCLUSIONS
Once daily revefenacin for nebulization can be an effective and well-tolerated treatment for patients who require concomitant use of LABA with or without ICS.
CLINICALTRIALS.GOV IDENTIFIERS
NCT02512510, NCT02459080, NCT02518139
Identifiants
pubmed: 32106777
doi: 10.1177/1753466620905278
pmc: PMC7052452
doi:
Substances chimiques
Adrenal Cortex Hormones
0
Adrenergic beta-Agonists
0
Benzamides
0
Bronchodilator Agents
0
Carbamates
0
Muscarinic Antagonists
0
revefenacin
G2AE2VE07O
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1753466620905278Références
NPJ Prim Care Respir Med. 2017 Apr 3;27(1):22
pubmed: 28373682
Int J Chron Obstruct Pulmon Dis. 2018 Sep 19;13:2917-2929
pubmed: 30275690
Thorax. 2015 Jun;70(6):519-27
pubmed: 25841237
Respir Med. 2012 Jan;106(1):91-101
pubmed: 22040533
Int J Chron Obstruct Pulmon Dis. 2016 Oct 18;11:2585-2596
pubmed: 27799757
Lancet Respir Med. 2017 Sep;5(9):691-706
pubmed: 28822787
Pulm Pharmacol Ther. 2018 Feb;48:71-79
pubmed: 28987804
PLoS Med. 2006 Nov;3(11):e442
pubmed: 17132052
BMJ. 2018 Nov 6;363:k4388
pubmed: 30401700
Respir Med. 2019 Jul;153:38-43
pubmed: 31150963
Chronic Obstr Pulm Dis. 2019 Apr 9;6(2):154-165
pubmed: 30974049
Respir Res. 2017 Nov 2;18(1):182
pubmed: 29096627
Am J Respir Crit Care Med. 2017 Aug 15;196(4):438-446
pubmed: 28375647
Respir Med. 2012 Mar;106(3):382-9
pubmed: 21975275
Clin Interv Aging. 2014;9:23-30
pubmed: 24376347
Respir Med. 1991 Sep;85 Suppl B:25-31; discussion 33-7
pubmed: 1759018
COPD. 2012 Feb;9(1):58-72
pubmed: 22292598
JAMA. 2013 Nov 27;310(20):2191-4
pubmed: 24141714
Thorax. 2008 Jul;63(7):592-8
pubmed: 18245142
Am J Respir Crit Care Med. 2009 Oct 15;180(8):741-50
pubmed: 19644045
COPD. 2016;13(1):1-10
pubmed: 26451734
Lancet. 2016 Sep 3;388(10048):963-73
pubmed: 27598678