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Once-daily fluticasone furoate/vilanterol versus twice daily combination therapies in asthma–mixed treatment comparisons of clinical efficacy
BACKGROUND: Fluticasone furoate (FF)/vilanterol (VI) is a once-daily inhaled corticosteroid (ICS)/long-acting beta(2) agonist (LABA) combination. FF/VI, 92/22mcg and 184/22mcg, are approved in Europe as maintenance therapy in persistent asthma. We report data from mixed treatment comparisons (MTC) o...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5142397/ https://www.ncbi.nlm.nih.gov/pubmed/27965772 http://dx.doi.org/10.1186/s40733-015-0016-0 |
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author | Svedsater, Henrik Stynes, Gillian Wex, Jaro Frith, Lucy Leather, David Castelnuovo, Emanuela Detry, Michelle Berry, Scott |
author_facet | Svedsater, Henrik Stynes, Gillian Wex, Jaro Frith, Lucy Leather, David Castelnuovo, Emanuela Detry, Michelle Berry, Scott |
author_sort | Svedsater, Henrik |
collection | PubMed |
description | BACKGROUND: Fluticasone furoate (FF)/vilanterol (VI) is a once-daily inhaled corticosteroid (ICS)/long-acting beta(2) agonist (LABA) combination. FF/VI, 92/22mcg and 184/22mcg, are approved in Europe as maintenance therapy in persistent asthma. We report data from mixed treatment comparisons (MTC) of once-daily FF/VI against established twice-daily ICS/LABA combination therapies on clinical efficacy outcomes. METHODS: Data from 31 parallel-group randomised controlled trials (RCTs) of ICS/LABA, of ≥8 weeks’ duration in patients aged ≥12 years with asthma, identified by systematic review, were analysed using covariate-adjusted Bayesian hierarchical models for four efficacy outcomes (primary analysis). Lung function, assessed by change from baseline morning peak expiratory flow (PEF) (n = 18 studies) and forced expiratory volume in 1 s (FEV(1)) (n = 28), was the outcome of primary interest. Secondary objectives were assessment of relative efficacy in terms of exacerbation rates (n = 6) and health status (n = 7). Overall, 24 different treatment arms were included in the MTC; we report findings comparing FF/VI (92/22mcg and 184/22mcg) with fluticasone propionate/salmeterol (FP/SAL) (250/50mcg and 500/50mcg) and budesonide/formoterol (BUD/FORM) (320/9mcg and 640/18mcg). RESULTS: For PEF (margin = 12 l/min), FF/VI 92/22mcg demonstrated ≥94 % probability and FF/VI 184/22mcg >99 % probability of non-inferiority to corresponding doses of both FP/SAL and BUD/FORM. For FEV(1) (margin = 100 ml), FF/VI demonstrated ≥98 % (92/22mcg) and >99 % (184/22mcg) probability of non-inferiority to both FP/SAL and BUD/FORM. Findings for exacerbations were inconclusive due to lack of data: FF/VI 92/22mcg demonstrated 74 % and 82 % probability of non-inferiority (margin = 10 %) to FP/SAL 250/50mcg and BUD/FORM 320/9mcg, respectively. For Asthma Quality of Life Questionnaire (AQLQ) score, FF/VI 92/22mcg demonstrated >99 % and 90 % probability of non-inferiority (margin = 0.25) to FP/SAL 250/50mcg and BUD/FORM 320/9mcg. Data were unavailable to assess non-inferiority of FF/VI 184/22mcg on exacerbations or AQLQ. CONCLUSIONS: Both strengths of once-daily FF/VI in asthma were comparable with corresponding doses of twice-daily FP/SAL and BUD/FORM in terms of lung function in this MTC analysis. FF/VI 92/22mcg was comparable with FP/SAL and BUD/FORM on AQLQ, but exacerbation results were inconclusive. Model limitations include disconnected treatment networks and variability across studies. Our data support previous RCT findings suggesting that the efficacy of once-daily FF/VI in improving lung function and health status in asthma is comparable with twice-daily ICS/LABAs. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s40733-015-0016-0) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5142397 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-51423972016-12-13 Once-daily fluticasone furoate/vilanterol versus twice daily combination therapies in asthma–mixed treatment comparisons of clinical efficacy Svedsater, Henrik Stynes, Gillian Wex, Jaro Frith, Lucy Leather, David Castelnuovo, Emanuela Detry, Michelle Berry, Scott Asthma Res Pract Research BACKGROUND: Fluticasone furoate (FF)/vilanterol (VI) is a once-daily inhaled corticosteroid (ICS)/long-acting beta(2) agonist (LABA) combination. FF/VI, 92/22mcg and 184/22mcg, are approved in Europe as maintenance therapy in persistent asthma. We report data from mixed treatment comparisons (MTC) of once-daily FF/VI against established twice-daily ICS/LABA combination therapies on clinical efficacy outcomes. METHODS: Data from 31 parallel-group randomised controlled trials (RCTs) of ICS/LABA, of ≥8 weeks’ duration in patients aged ≥12 years with asthma, identified by systematic review, were analysed using covariate-adjusted Bayesian hierarchical models for four efficacy outcomes (primary analysis). Lung function, assessed by change from baseline morning peak expiratory flow (PEF) (n = 18 studies) and forced expiratory volume in 1 s (FEV(1)) (n = 28), was the outcome of primary interest. Secondary objectives were assessment of relative efficacy in terms of exacerbation rates (n = 6) and health status (n = 7). Overall, 24 different treatment arms were included in the MTC; we report findings comparing FF/VI (92/22mcg and 184/22mcg) with fluticasone propionate/salmeterol (FP/SAL) (250/50mcg and 500/50mcg) and budesonide/formoterol (BUD/FORM) (320/9mcg and 640/18mcg). RESULTS: For PEF (margin = 12 l/min), FF/VI 92/22mcg demonstrated ≥94 % probability and FF/VI 184/22mcg >99 % probability of non-inferiority to corresponding doses of both FP/SAL and BUD/FORM. For FEV(1) (margin = 100 ml), FF/VI demonstrated ≥98 % (92/22mcg) and >99 % (184/22mcg) probability of non-inferiority to both FP/SAL and BUD/FORM. Findings for exacerbations were inconclusive due to lack of data: FF/VI 92/22mcg demonstrated 74 % and 82 % probability of non-inferiority (margin = 10 %) to FP/SAL 250/50mcg and BUD/FORM 320/9mcg, respectively. For Asthma Quality of Life Questionnaire (AQLQ) score, FF/VI 92/22mcg demonstrated >99 % and 90 % probability of non-inferiority (margin = 0.25) to FP/SAL 250/50mcg and BUD/FORM 320/9mcg. Data were unavailable to assess non-inferiority of FF/VI 184/22mcg on exacerbations or AQLQ. CONCLUSIONS: Both strengths of once-daily FF/VI in asthma were comparable with corresponding doses of twice-daily FP/SAL and BUD/FORM in terms of lung function in this MTC analysis. FF/VI 92/22mcg was comparable with FP/SAL and BUD/FORM on AQLQ, but exacerbation results were inconclusive. Model limitations include disconnected treatment networks and variability across studies. Our data support previous RCT findings suggesting that the efficacy of once-daily FF/VI in improving lung function and health status in asthma is comparable with twice-daily ICS/LABAs. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s40733-015-0016-0) contains supplementary material, which is available to authorized users. BioMed Central 2016-02-08 /pmc/articles/PMC5142397/ /pubmed/27965772 http://dx.doi.org/10.1186/s40733-015-0016-0 Text en © Svedsater et al. 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Svedsater, Henrik Stynes, Gillian Wex, Jaro Frith, Lucy Leather, David Castelnuovo, Emanuela Detry, Michelle Berry, Scott Once-daily fluticasone furoate/vilanterol versus twice daily combination therapies in asthma–mixed treatment comparisons of clinical efficacy |
title | Once-daily fluticasone furoate/vilanterol versus twice daily combination therapies in asthma–mixed treatment comparisons of clinical efficacy |
title_full | Once-daily fluticasone furoate/vilanterol versus twice daily combination therapies in asthma–mixed treatment comparisons of clinical efficacy |
title_fullStr | Once-daily fluticasone furoate/vilanterol versus twice daily combination therapies in asthma–mixed treatment comparisons of clinical efficacy |
title_full_unstemmed | Once-daily fluticasone furoate/vilanterol versus twice daily combination therapies in asthma–mixed treatment comparisons of clinical efficacy |
title_short | Once-daily fluticasone furoate/vilanterol versus twice daily combination therapies in asthma–mixed treatment comparisons of clinical efficacy |
title_sort | once-daily fluticasone furoate/vilanterol versus twice daily combination therapies in asthma–mixed treatment comparisons of clinical efficacy |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5142397/ https://www.ncbi.nlm.nih.gov/pubmed/27965772 http://dx.doi.org/10.1186/s40733-015-0016-0 |
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