In patients with COPD who have a history of exacerbations, a once-daily treatment regimen of combined fluticasone furoate and vilanterol was associated with fewer exacerbations than usual care without a greater risk of serious adverse events, according to a newly published study in the New England Journal of Medicine
In a controlled effectiveness trial conducted in 75 general practices, researchers randomly assigned 2,799 patients with COPD to a once-daily inhaled combination of fluticasone furoate (100 μg) and vilanterol (25 μg) or to usual care.
The rate of moderate or severe exacerbations—the primary outcome—was significantly lower, by 8.4% (95% confidence interval, 1.1 to 15.2), with fluticasone furoate–vilanterol therapy than with usual care (P=0.02).
Secondary outcomes included rates of primary and secondary care contact, modification of the initial trial treatment for COPD, and exacerbation rates. Among the findings:
-There was no significant difference in the annual rates of COPD-related contacts to primary or secondary care.
-There were no significant between-group differences in the rates of the first moderate or severe exacerbation and the first severe exacerbation.
-There were no excess serious adverse events of pneumonia in the fluticasone furoate–vilanterol group.
-The numbers of other serious adverse events were comparable in the two groups.
The take home message? Patients with COPD who are at heightened risk of exacerbations benefitted from simple, once-daily inhaled combination treatment with fluticasone furoate and vilanterol, without an additional risk of serious adverse events.