Am J Respir Crit Care Med. 2017 Apr 1;195(7):881-888. doi: 10.1164/rccm.201607-1421OC
Martinez FJ1,2, Vestbo J3, Anderson JA4, Brook RD2, Celli BR5, Cowans NJ6, Crim C7, Dransfield M8, Kilbride S4, Yates J7, Newby DE9, Niewoehner D10, Calverley PM11; SUMMIT Investigators.
Author information:
1 Division of Pulmonary and Critical Care Medicine, Weill Cornell Medicine, New York, New York.
2 University of Michigan Health System, Ann Arbor, Michigan.
3 Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre, The University of Manchester and South Manchester, Manchester, United Kingdom.
4 Research & Development, GlaxoSmithKline, Stockley Park, Middlesex, United Kingdom.
5 Pulmonary and Critical Care Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts.
6 Veramed Ltd., Twickenham, United Kingdom.
7 Research & Development, GlaxoSmithKline, Research Triangle Park, North Carolina.
8 University of Alabama Birmingham, Birmingham, Alabama.
9 Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.
10 University of Minnesota, Minneapolis, Minnesota; and.
11 University of Liverpool, Department of Medicine, Clinical Sciences Centre, University Hospital Aintree, Liverpool, United Kingdom.
Abstract
RATIONALE:
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.
OBJECTIVES:
This was an analysis of exacerbations in the SUMMIT (Study to Understand Mortality and Morbidity) study.
METHODS:
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.
MEASUREMENTS AND MAIN RESULTS:
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 FEV1 but 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.
CONCLUSIONS:
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).
PMID: 27767328
Similar articles