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.
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.
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.
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.
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).