BACKGROUND: Inhaled corticosteroids have been shown to decrease exacerbations in COPD patients with moderate to severe COPD. Their effect in patients with milder airflow obstruction remains unclear.
OBJECTIVE: This was an analysis of exacerbations in the Study to Understand Mortality and MorbidITy (SUMMIT) study.
DESIGN: In a double-blind randomized controlled trial, once daily inhaled placebo, fluticasone furoate (FF, 100 μg), vilanterol (VI, 25 μg) or the combination (FF/VI) was administered. The primary outcome was all-cause mortality. Exacerbations of COPD were an additional pre-defined endpoint.
SETTING: 1,368 centers in 43 countries.
PARTICIPANTS: 16,485 patients with moderate COPD and heightened cardiovascular risk.
RESULTS: Compared with placebo, FF/VI reduced the rate of moderate/severe exacerbations by 29% (95% 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 prior to the study or an FEV1 less than or ≥ 60% predicted. The number needed to treat was not influenced by baseline FEV1 but was influenced by the prior history of exacerbations. FF/VI also reduced the rate of exacerbations treated with corticosteroids alone or with corticosteroids and antibiotics but not 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 prior history of exacerbations or baseline FEV1. Clinical trial registration available at www.clinicaltrials.gov, ID NCT01313676.
|Journal||American Journal of Respiratory and Critical Care Medicine|
|Publication status||Published - 21 Oct 2016|