Magnitude of umeclidinium/vilanterol lung function effect depends on monotherapy responses: Results from two randomised controlled trials.
Respir Med
; 112: 65-74, 2016 Mar.
Article
em En
| MEDLINE
| ID: mdl-26797016
ABSTRACT
PURPOSE:
Dual therapy with bronchodilators of different pharmacological classes may produce greater lung function improvements than either drug alone. However, the relationship between a patient's response to monotherapy and response to dual bronchodilator therapy is currently unknown. We aimed to investigate whether dual therapy with umeclidinium/vilanterol provides additional benefit over umeclidinium or vilanterol monotherapy in patients with chronic obstructive pulmonary disease (COPD) identified as responsive (increase from baseline in forced expiratory volume in 1s [FEV1] of ≥ 12% and ≥ 200 mL, Day 1) or non-responsive to monotherapy.METHODS:
In two randomised, double-blind, three-way complete-block, cross-over studies (DB2116132 n = 207; DB2116133 n = 182; intent-to-treat), all patients (moderate-to-very severe COPD) were randomised to 1 of 6 sequences and received once-daily umeclidinium 62.5 mcg, vilanterol 25 mcg, and umeclidinium/vilanterol 62.5/25 mcg (one treatment/14-day period; 10-14-day washout). Key endpoints were 0-6 h weighted mean FEV1 (Day 14) and trough FEV1 (Day 15). Adverse events, vital signs and COPD exacerbations were assessed. Pooled data are presented.RESULTS:
Umeclidinium/vilanterol significantly (p ≤ 0.001, unless stated otherwise) increased 0-6 h weighted mean FEV1 versus umeclidinium in umeclidinium-responders (+114 mL), versus vilanterol in vilanterol-responders (+92 mL) and versus umeclidinium (+70 mL) and vilanterol (+62 mL) in non-responders. Improvements in trough FEV1 occurred with umeclidinium/vilanterol versus umeclidinium in umeclidinium-responders (+77 mL), versus vilanterol in vilanterol-responders (+86 mL), and versus umeclidinium (+42 mL [p = 0.020]) and vilanterol (+58 mL) in non-responders. All treatments were well tolerated.CONCLUSIONS:
Once-daily umeclidinium/vilanterol significantly improved lung function in patients with COPD, with quantitatively greater improvements in patients identified as responders to umeclidinium and vilanterol monotherapy than non-responders.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Quinuclidinas
/
Álcoois Benzílicos
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Broncodilatadores
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Clorobenzenos
/
Agonistas Adrenérgicos beta
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Antagonistas Muscarínicos
/
Doença Pulmonar Obstrutiva Crônica
Tipo de estudo:
Clinical_trials
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Respir Med
Ano de publicação:
2016
Tipo de documento:
Article