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Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol in Maintenance-Naïve Patients with Moderate Symptomatic Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis.
Pulm Ther. 2018 Dec; 4(2):171-183.PT

Abstract

INTRODUCTION

Appropriate timing for dual bronchodilator therapy initiation in chronic obstructive pulmonary disease (COPD) management is uncertain. Combination therapy is recommended as step-up from monotherapy or first-line treatment in patients with persistent symptoms. In this setting, umeclidinium/vilanterol (UMEC/VI) demonstrated improved lung function and reduced rescue medication use over tiotropium/olodaterol (TIO/OLO). This subgroup analysis explored efficacy differences between these combinations in patients naïve to COPD maintenance therapy before study entry.

METHODS

Post hoc analysis of an 8-week, randomized, open-label, assessor-blind, two-period crossover study (204990; NCT02799784) comparing UMEC/VI 62.5/25 mcg and TIO/OLO 5/5 mcg, focused on maintenance-naïve (MN) patients with moderate COPD and persistent symptoms (modified Medical Research Council dyspnea score ≥ 2). Change from baseline (CFB) in trough forced expiratory volume in 1 s (FEV1), percentage of FEV1 responders (CFB ≥ 100 ml), rescue medication use and safety were evaluated.

RESULTS

The MN population comprised 63% of the intent-to-treat (ITT) population (148/236 patients) and had similar baseline demographics. At week 8, adjusted mean (standard error) improvements in trough FEV1 from baseline were clinically meaningful for both combinations (UMEC/VI: 167 [17] ml; TIO/OLO 110 [18] ml; adjusted mean difference [95% confidence interval (CI)]: 57 [23-92] ml; p = 0.001; %CFB: 11 vs. 8%). Proportion of FEV1 responders was greater with UMEC/VI versus TIO/OLO at week 8 (60 vs. 42%; odds ratio [95% CI] 1.90 [1.12-3.22]; p = 0.018). Reduction in rescue medication use was 0.20 (95% CI 0.07-0.34) puffs/day greater with UMEC/VI versus TIO/OLO over weeks 1-8 (p = 0.003). Adverse events incidence was similar (UMEC/VI: 24%; TIO/OLO: 29%).

CONCLUSIONS

These results highlight that the efficacy difference between UMEC/VI and TIO/OLO demonstrated in the ITT population is maintained in MN patients. Greater lung function improvements with UMEC/VI versus TIO/OLO were accompanied by symptom improvements, as reflected in a significantly lower need for supplemental rescue medication.

FUNDING

GSK.

TRIAL REGISTRATION

NCT02799784.

Authors+Show Affiliations

Neumología, Hospital de Alta Resolución de Loja, Granada, Spain. balcazarnavarrete@gmail.com.Global Respiratory Franchise, GSK, Brentford, Middlesex, UK.Global Respiratory Franchise, GSK, Brentford, Middlesex, UK.Precise Approach Ltd, Contingent Worker on Assignment at GSK, Stockley Park West, Uxbridge, Middlesex, UK.Respiratory Research and Development, GSK, Collegeville, PA, USA.Global Respiratory Franchise, GSK, Brentford, Middlesex, UK.Discovery Medicine, GSK, Stockley Park West, Uxbridge, Middlesex, UK.South Carolina Pharmaceutical Research, Spartanburg, SC, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32026389

Citation

Alcázar Navarrete, Bernardino, et al. "Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol in Maintenance-Naïve Patients With Moderate Symptomatic Chronic Obstructive Pulmonary Disease: a Post Hoc Analysis." Pulmonary Therapy, vol. 4, no. 2, 2018, pp. 171-183.
Alcázar Navarrete B, Boucot I, Naya I, et al. Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol in Maintenance-Naïve Patients with Moderate Symptomatic Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis. Pulm Ther. 2018;4(2):171-183.
Alcázar Navarrete, B., Boucot, I., Naya, I., Tombs, L., Lipson, D. A., Compton, C., Sousa, A. R., & Feldman, G. (2018). Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol in Maintenance-Naïve Patients with Moderate Symptomatic Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis. Pulmonary Therapy, 4(2), 171-183. https://doi.org/10.1007/s41030-018-0057-7
Alcázar Navarrete B, et al. Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol in Maintenance-Naïve Patients With Moderate Symptomatic Chronic Obstructive Pulmonary Disease: a Post Hoc Analysis. Pulm Ther. 2018;4(2):171-183. PubMed PMID: 32026389.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol in Maintenance-Naïve Patients with Moderate Symptomatic Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis. AU - Alcázar Navarrete,Bernardino, AU - Boucot,Isabelle, AU - Naya,Ian, AU - Tombs,Lee, AU - Lipson,David A, AU - Compton,Chris, AU - Sousa,Ana R, AU - Feldman,Gregory, Y1 - 2018/06/20/ PY - 2018/04/16/received PY - 2020/2/7/entrez PY - 2018/12/1/pubmed PY - 2018/12/1/medline KW - COPD KW - LABA KW - LAMA KW - Long-acting muscarinic antagonist KW - Long-acting β2-agonist KW - Maintenance-naïve KW - Olodaterol KW - Tiotropium KW - Umeclidinium KW - Vilanterol SP - 171 EP - 183 JF - Pulmonary therapy JO - Pulm Ther VL - 4 IS - 2 N2 - INTRODUCTION: Appropriate timing for dual bronchodilator therapy initiation in chronic obstructive pulmonary disease (COPD) management is uncertain. Combination therapy is recommended as step-up from monotherapy or first-line treatment in patients with persistent symptoms. In this setting, umeclidinium/vilanterol (UMEC/VI) demonstrated improved lung function and reduced rescue medication use over tiotropium/olodaterol (TIO/OLO). This subgroup analysis explored efficacy differences between these combinations in patients naïve to COPD maintenance therapy before study entry. METHODS: Post hoc analysis of an 8-week, randomized, open-label, assessor-blind, two-period crossover study (204990; NCT02799784) comparing UMEC/VI 62.5/25 mcg and TIO/OLO 5/5 mcg, focused on maintenance-naïve (MN) patients with moderate COPD and persistent symptoms (modified Medical Research Council dyspnea score ≥ 2). Change from baseline (CFB) in trough forced expiratory volume in 1 s (FEV1), percentage of FEV1 responders (CFB ≥ 100 ml), rescue medication use and safety were evaluated. RESULTS: The MN population comprised 63% of the intent-to-treat (ITT) population (148/236 patients) and had similar baseline demographics. At week 8, adjusted mean (standard error) improvements in trough FEV1 from baseline were clinically meaningful for both combinations (UMEC/VI: 167 [17] ml; TIO/OLO 110 [18] ml; adjusted mean difference [95% confidence interval (CI)]: 57 [23-92] ml; p = 0.001; %CFB: 11 vs. 8%). Proportion of FEV1 responders was greater with UMEC/VI versus TIO/OLO at week 8 (60 vs. 42%; odds ratio [95% CI] 1.90 [1.12-3.22]; p = 0.018). Reduction in rescue medication use was 0.20 (95% CI 0.07-0.34) puffs/day greater with UMEC/VI versus TIO/OLO over weeks 1-8 (p = 0.003). Adverse events incidence was similar (UMEC/VI: 24%; TIO/OLO: 29%). CONCLUSIONS: These results highlight that the efficacy difference between UMEC/VI and TIO/OLO demonstrated in the ITT population is maintained in MN patients. Greater lung function improvements with UMEC/VI versus TIO/OLO were accompanied by symptom improvements, as reflected in a significantly lower need for supplemental rescue medication. FUNDING: GSK. TRIAL REGISTRATION: NCT02799784. SN - 2364-1746 UR - https://www.unboundmedicine.com/medline/citation/32026389/Umeclidinium/Vilanterol_Versus_Tiotropium/Olodaterol_in_Maintenance_Naïve_Patients_with_Moderate_Symptomatic_Chronic_Obstructive_Pulmonary_Disease:_A_Post_Hoc_Analysis_ L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/32026389/ DB - PRIME DP - Unbound Medicine ER -