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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; 57:101802PP

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
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, p. 101802. doi: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 - 2019/5/17/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 -