Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol in Maintenance-Naïve Patients with Moderate Symptomatic Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2018-06-20

AUTHORS

Bernardino Alcázar Navarrete, Isabelle Boucot, Ian Naya, Lee Tombs, David A. Lipson, Chris Compton, Ana R. Sousa, Gregory Feldman

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. More... »

PAGES

171-183

References to SciGraph publications

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  • 2010-09-30. Disease severity and symptoms among patients receiving monotherapy for COPD in NPJ PRIMARY CARE RESPIRATORY MEDICINE
  • 2017-08-22. A Network Meta-Analysis of Long-Acting Muscarinic Antagonist (LAMA) and Long-Acting β2-Agonist (LABA) Combinations in COPD in PULMONARY THERAPY
  • 2016-02-22. Triple Therapy of Umeclidinium + Inhaled Corticosteroids/Long-Acting Beta2 Agonists for Patients with COPD: Pooled Results of Randomized Placebo-Controlled Trials in PULMONARY THERAPY
  • 2013-05-08. Combination bronchodilator therapy in the management of chronic obstructive pulmonary disease in RESPIRATORY RESEARCH
  • 2016-02-19. Prevalence and Burden of Dyspnoea Among Patients with Chronic Obstructive Pulmonary Disease in Five European Countries in PULMONARY THERAPY
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    19 schema:description 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 (FEV<sub>1</sub>), percentage of FEV<sub>1</sub> 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 FEV<sub>1</sub> 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 FEV<sub>1</sub> 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.
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    26 schema:keywords COPD
    27 COPD maintenance therapy
    28 FEV
    29 GSK
    30 Greater lung function improvements
    31 Hoc Analysis
    32 ITT population
    33 MN patients
    34 MN population
    35 Moderate Symptomatic Chronic Obstructive Pulmonary Disease
    36 NCT02799784
    37 OLO
    38 OLO 5/5
    39 Post Hoc Analysis
    40 Proportion of FEV
    41 TIO/OLO
    42 TIO/OLO 5/5
    43 TiO
    44 UMEC/VI
    45 UMEC/VI 62.5/25
    46 Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol
    47 VI 62.5/25
    48 Versus Tiotropium/Olodaterol
    49 Vilanterol Versus Tiotropium/Olodaterol
    50 adverse event incidence
    51 analysis
    52 appropriate timing
    53 baseline
    54 baseline demographics
    55 bronchodilator therapy initiation
    56 changes
    57 chronic obstructive pulmonary disease
    58 chronic obstructive pulmonary disease (COPD) management
    59 combination
    60 combination therapy
    61 crossover study
    62 days
    63 demographics
    64 differences
    65 disease
    66 disease management
    67 dual bronchodilator therapy initiation
    68 efficacy differences
    69 entry
    70 event incidence
    71 expiratory volume
    72 first-line treatment
    73 function
    74 function improvement
    75 improvement
    76 incidence
    77 initiation
    78 intent
    79 lower need
    80 lung function
    81 lung function improvement
    82 maintenance therapy
    83 maintenance-naïve patients
    84 management
    85 mcg
    86 mean improvement
    87 medication use
    88 medications
    89 moderate COPD
    90 monotherapy
    91 need
    92 obstructive pulmonary disease
    93 obstructive pulmonary disease (COPD) management
    94 olodaterol
    95 patients
    96 percentage
    97 percentage of FEV
    98 persistent symptoms
    99 population
    100 post
    101 proportion
    102 puffs/day
    103 pulmonary disease
    104 pulmonary disease (COPD) management
    105 reduction
    106 rescue medication
    107 rescue medication use
    108 responders
    109 results
    110 safety
    111 setting
    112 similar baseline demographics
    113 study
    114 study entry
    115 subgroup analysis
    116 supplemental rescue medication
    117 symptom improvement
    118 symptomatic chronic obstructive pulmonary disease
    119 symptoms
    120 therapy
    121 therapy initiation
    122 timing
    123 tiotropium/olodaterol
    124 treat population
    125 treatment
    126 trough
    127 trough FEV
    128 two-period crossover study
    129 umeclidinium/vilanterol
    130 use
    131 vilanterol
    132 volume
    133 week 1
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