Efficacy and safety of the dual bronchodilator combination umeclidinium/vilanterol in COPD by age and airflow limitation severity: A pooled post hoc analysis of seven clinical trials.


Journal

Pulmonary pharmacology & therapeutics
ISSN: 1522-9629
Titre abrégé: Pulm Pharmacol Ther
Pays: England
ID NLM: 9715279

Informations de publication

Date de publication:
08 2019
Historique:
received: 11 01 2019
revised: 01 05 2019
accepted: 08 05 2019
pubmed: 17 5 2019
medline: 16 4 2020
entrez: 17 5 2019
Statut: ppublish

Résumé

Elderly patients with chronic obstructive pulmonary disease (COPD) and those with more severe airway limitation are perceived to experience reduced efficacy from inhaled bronchodilators, especially those administered in a dry powder inhaler. This study compared the efficacy and safety of a long-acting muscarinic antagonist/long-acting β This post hoc pooled analysis of seven randomized studies of ≥12 weeks' duration investigated the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) 62.5/25 μg versus tiotropium (TIO) 18 μg or fluticasone propionate/salmeterol (FP/SAL) 250/50 μg. Change from baseline in trough forced expiratory volume in 1 s (FEV The pooled intent-to-treat population comprised 3821 patients (≥65 years: 44-45%; ≥75 years: 9-10%; GOLD stage 3/4: 50-55%); 2246, 874, and 701 patients received UMEC/VI, TIO, or FP/SAL, respectively. Significant improvements in trough FEV UMEC/VI consistently demonstrated improved lung function versus TIO and FP/SAL across age and airflow limitation severity subgroups, with no safety concerns, indicating that UMEC/VI provides no loss in efficacy or additional safety concerns for both elderly patients with COPD and patients with severe/very severe airway limitation.

Sections du résumé

BACKGROUND
Elderly patients with chronic obstructive pulmonary disease (COPD) and those with more severe airway limitation are perceived to experience reduced efficacy from inhaled bronchodilators, especially those administered in a dry powder inhaler. This study compared the efficacy and safety of a long-acting muscarinic antagonist/long-acting β
METHODS
This post hoc pooled analysis of seven randomized studies of ≥12 weeks' duration investigated the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) 62.5/25 μg versus tiotropium (TIO) 18 μg or fluticasone propionate/salmeterol (FP/SAL) 250/50 μg. Change from baseline in trough forced expiratory volume in 1 s (FEV
RESULTS
The pooled intent-to-treat population comprised 3821 patients (≥65 years: 44-45%; ≥75 years: 9-10%; GOLD stage 3/4: 50-55%); 2246, 874, and 701 patients received UMEC/VI, TIO, or FP/SAL, respectively. Significant improvements in trough FEV
CONCLUSION
UMEC/VI consistently demonstrated improved lung function versus TIO and FP/SAL across age and airflow limitation severity subgroups, with no safety concerns, indicating that UMEC/VI provides no loss in efficacy or additional safety concerns for both elderly patients with COPD and patients with severe/very severe airway limitation.

Identifiants

pubmed: 31096036
pii: S1094-5539(19)30015-X
doi: 10.1016/j.pupt.2019.101802
pii:
doi:

Substances chimiques

Benzyl Alcohols 0
Bronchodilator Agents 0
Chlorobenzenes 0
Drug Combinations 0
Fluticasone-Salmeterol Drug Combination 0
GSK573719 0
Muscarinic Antagonists 0
Quinuclidines 0
vilanterol 028LZY775B
Tiotropium Bromide XX112XZP0J

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

101802

Informations de copyright

Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.

Auteurs

Riju Ray (R)

US Medical Affairs, GSK, 5 Moore Drive, Research Triangle Park, NC, 27709-3398, USA. Electronic address: riju.x.ray@gsk.com.

Lee Tombs (L)

Precise Approach Ltd, Contingent Worker on Assignment at GSK, Stockley Park West, Uxbridge, Middlesex, UK. Electronic address: lee.x.tombs@gsk.com.

Ian Naya (I)

Global Respiratory Franchise, GSK, 980 Great West Road, Brentford, Middlesex, UK. Electronic address: ian.p.naya@gsk.com.

Chris Compton (C)

Global Respiratory Franchise, GSK, 980 Great West Road, Brentford, Middlesex, UK. Electronic address: chris.h.compton@gsk.com.

David A Lipson (DA)

Respiratory Research and Development, GSK, 1250 S Collegeville Rd, Collegeville, PA, PA, 19426, USA; Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA, 19104, USA. Electronic address: david.a.lipson@gsk.com.

Isabelle Boucot (I)

Global Respiratory Franchise, GSK, 980 Great West Road, Brentford, Middlesex, UK. Electronic address: isabelle.i.boucot@gsk.com.

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Classifications MeSH