title: Effect of Fluticasone Furoate and Vilanterol on Exacerbations of Chronic Obstructive Pulmonary Disease in Patients with Moderate Airflow Obstruction.
abstract: Inhaled corticosteroids have been shown to decrease exacerbations in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Their effects in patients with milder airflow obstruction remain unclear.
  
  
  
  This was an analysis of exacerbations in the SUMMIT (Study to Understand Mortality and Morbidity) study.
  
  
  
  In a double-blind, randomized controlled trial, once-daily inhaled placebo, fluticasone furoate (FF; 100 μg), vilanterol (VI; 25 μg), or the combination of FF/VI was administered. The primary outcome was all-cause mortality. Exacerbations of COPD were an additional predefined endpoint. A total of 1,368 centers in 43 countries and 16,485 patients with moderate COPD and heightened cardiovascular risk were included in the study.
  
  
  
  Compared with placebo, FF/VI reduced the rate of moderate and/or severe exacerbations by 29% (95% confidence interval [CI], 22-35; P < 0.001) and the rate of hospitalized exacerbations by 27% (95% CI, 13-39; P < 0.001). These relative effects were similar regardless of whether subjects had a history of exacerbation in the year before the study or an FEV1<60% or ≥60% of predicted. The number needed to treat was not influenced by baseline FEV1but was influenced by the history of exacerbations. FF/VI also reduced the rate of exacerbations treated with corticosteroids alone or with corticosteroids and antibiotics but not the rates of those treated with antibiotics alone.
  
  
  
  Patients with moderate chronic airflow obstruction experienced a reduction in exacerbations with FF/VI compared with placebo, irrespective of a history of exacerbations or baseline FEV1. Clinical trial registered with www.clinicaltrials.gov (NCT 01313676; GSK Study number 113782).
authors: 1 Division of Pulmonary and Critical Care Medicine, Weill Cornell Medicine, New York, New York.|2 University of Michigan Health System, Ann Arbor, Michigan.
authors: Fernando J
authors: FJ
authors: Martinez
authors: 3 Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre, The University of Manchester and South Manchester, Manchester, United Kingdom.
authors: Jørgen
authors: J
authors: Vestbo
authors: 4 Research & Development, GlaxoSmithKline, Stockley Park, Middlesex, United Kingdom.
authors: Julie A
authors: JA
authors: Anderson
authors: 2 University of Michigan Health System, Ann Arbor, Michigan.
authors: Robert D
authors: RD
authors: Brook
authors: 5 Pulmonary and Critical Care Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors: Bartolome R
authors: BR
authors: Celli
authors: 6 Veramed Ltd., Twickenham, United Kingdom.
authors: Nicholas J
authors: NJ
authors: Cowans
authors: 7 Research & Development, GlaxoSmithKline, Research Triangle Park, North Carolina.
authors: Courtney
authors: C
authors: Crim
authors: 8 University of Alabama Birmingham, Birmingham, Alabama.
authors: Mark
authors: M
authors: Dransfield
authors: 4 Research & Development, GlaxoSmithKline, Stockley Park, Middlesex, United Kingdom.
authors: Sally
authors: S
authors: Kilbride
authors: 7 Research & Development, GlaxoSmithKline, Research Triangle Park, North Carolina.
authors: Julie
authors: J
authors: Yates
authors: 9 Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.
authors: David E
authors: DE
authors: Newby
authors: 10 University of Minnesota, Minneapolis, Minnesota; and.
authors: Dennis
authors: D
authors: Niewoehner
authors: 11 University of Liverpool, Department of Medicine, Clinical Sciences Centre, University Hospital Aintree, Liverpool, United Kingdom.
authors: Peter M A
authors: PM
authors: Calverley
mesh_terms: D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000494:pharmacology; D000368:Aged; D000402:Airway Obstruction / Q000150:complications / Q000503:physiopathology / Q000628:therapy; D000730:Androstadienes / Q000494:pharmacology*; D001592:Benzyl Alcohols / Q000494:pharmacology*; D001993:Bronchodilator Agents / Q000494:pharmacology; D002722:Chlorobenzenes / Q000494:pharmacology*; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000730:Androstadienes; D001592:Benzyl Alcohols; D001993:Bronchodilator Agents; D002722:Chlorobenzenes; C550468:vilanterol; C523187:fluticasone furoate
keywords: COPD; cardiovascular disease; exacerbations; fluticasone furoate; vilanterol