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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.

Authors+Show Affiliations

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

Pub Type(s)

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

Language

eng

PubMed ID

31096036

Citation

Ray, Riju, et al. "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." Pulmonary Pharmacology & Therapeutics, vol. 57, 2019, p. 101802.
Ray R, Tombs L, Naya I, et al. 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;57:101802.
Ray, R., Tombs, L., Naya, I., Compton, C., Lipson, D. A., & Boucot, I. (2019). 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. Pulmonary Pharmacology & Therapeutics, 57, 101802. https://doi.org/10.1016/j.pupt.2019.101802
Ray R, et al. 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;57:101802. PubMed PMID: 31096036.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Ray,Riju, AU - Tombs,Lee, AU - Naya,Ian, AU - Compton,Chris, AU - Lipson,David A, AU - Boucot,Isabelle, Y1 - 2019/05/13/ PY - 2019/01/11/received PY - 2019/05/01/revised PY - 2019/05/08/accepted PY - 2019/5/17/pubmed PY - 2020/4/16/medline PY - 2019/5/17/entrez KW - (Max. 6): COPD KW - Dry powder inhaler KW - Elderly KW - GOLD stage KW - LAMA/LABA KW - Umeclidinium/vilanterol SP - 101802 EP - 101802 JF - Pulmonary pharmacology & therapeutics JO - Pulm Pharmacol Ther VL - 57 N2 - 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. SN - 1522-9629 UR - https://www.unboundmedicine.com/medline/citation/31096036/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1094-5539(19)30015-X DB - PRIME DP - Unbound Medicine ER -