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Once-daily fluticasone furoate (FF)/vilanterol reduces risk of severe exacerbations in asthma versus FF alone.
- Source :
- Thorax; Apr2014, Vol. 69 Issue 4, p312-319, 8p, 1 Diagram, 3 Charts, 3 Graphs
- Publication Year :
- 2014
-
Abstract
- Background: Combination therapy with an inhaled corticosteroid (ICS) and long-acting β<subscript>2</subscript> agonist (LABA) is recommended for patients with asthma symptomatic on ICS alone. However, there is ongoing debate regarding the risk-benefit ratio of using LABA in asthma. Objective: To evaluate the effect of the addition of a novel LABA, vilanterol (VI), to a once-daily ICS, fluticasone furoate (FF), on the risk of severe asthma exacerbations in patients with uncontrolled asthma. Methods: This randomised double-blind comparative study of variable duration (≥24-78 weeks) was designed to finish after 330 events (each patient's first ontreatment severe asthma exacerbation). 2019 patients with asthma aged ≥12 years with ≥1 recorded exacerbation within 1 year were randomised and received FF/VI 100/25 μg or FF 100 μg, administered once daily in the evening. The primary endpoint was time to first severe exacerbation; secondary endpoints were rate of severe asthma exacerbations per patient per year and change in trough evening forced expiratory volume in 1 s (FEV<subscript>1</subscript>) from baseline. Results: Compared with FF, FF/VI delayed the time to first severe exacerbation (HR 0.795, 95% CI 0.642 to 0.985) and reduced the annualised rate of severe exacerbations (rate reduction 25%, 95% CI 5% to 40%). Significantly greater improvements in trough FEV<subscript>1</subscript> (p<0.001) were observed with FF/VI than with FF at weeks 12, 36, 52 and at endpoint. Both treatments were well tolerated with similar rates of treatmentrelated adverse events and on-treatment serious adverse events. Conclusions: Once-daily FF/VI reduced the risk of severe asthma exacerbations and improved lung function compared with FF alone, with good tolerability and safety profile in adolescents and adults with asthma currently receiving ICS. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00406376
- Volume :
- 69
- Issue :
- 4
- Database :
- Complementary Index
- Journal :
- Thorax
- Publication Type :
- Academic Journal
- Accession number :
- 94934361
- Full Text :
- https://doi.org/10.1136/thoraxjnl-2013-203600