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.
Pulm Pharmacol Ther. 2019 08; 57:101802.PP

Abstract

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 β2-agonist dry powder combination in elderly patients with COPD and patients with moderate-to-very severe airflow limitation.

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 (FEV1), a common efficacy measure in all trials, proportion of FEV1 responders (≥100 mL increase from baseline) and safety outcomes were analyzed at Day 28, 56, and 84 in patients classified by age (<65, ≥65, and ≥75 years of age) and severity of baseline airflow limitation (Global initiative for chronic Obstructive Lung Disease [GOLD] stage 2 [moderate] and stage 3/4 [severe/very severe]). A 24-week analysis was also conducted for the UMEC/VI versus TIO comparison.

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 FEV1 at Day 84 were observed with UMEC/VI versus TIO or FP/SAL irrespective of age (all p ≤ 0.029) or GOLD stage (all p < 0.001). The proportion of FEV1 responders at Day 84 was significantly greater with UMEC/VI versus TIO or FP/SAL across all age groups (all p ≤ 0.016) and GOLD stages (all p < 0.001). Safety profiles were similar between treatment groups.

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.

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Authors+Show Affiliations

Ray R
US Medical Affairs, GSK, 5 Moore Drive, Research Triangle Park, NC, 27709-3398, USA. Electronic address: riju.x.ray@gsk.com.
Tombs L
Precise Approach Ltd, Contingent Worker on Assignment at GSK, Stockley Park West, Uxbridge, Middlesex, UK. Electronic address: lee.x.tombs@gsk.com.
Naya I
Global Respiratory Franchise, GSK, 980 Great West Road, Brentford, Middlesex, UK. Electronic address: ian.p.naya@gsk.com.
Compton C
Global Respiratory Franchise, GSK, 980 Great West Road, Brentford, Middlesex, UK. Electronic address: chris.h.compton@gsk.com.
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.
Boucot I
Global Respiratory Franchise, GSK, 980 Great West Road, Brentford, Middlesex, UK. Electronic address: isabelle.i.boucot@gsk.com.

MeSH

Administration, InhalationAdultAgedAged, 80 and overBenzyl AlcoholsBronchodilator AgentsChlorobenzenesDrug CombinationsFemaleFluticasone-Salmeterol Drug CombinationForced Expiratory VolumeHumansLungMaleMiddle AgedMuscarinic AntagonistsPulmonary Disease, Chronic ObstructiveQuinuclidinesTiotropium BromideTreatment Outcome

Pub Type(s)

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

Language

eng

PubMed ID

31096036