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Fluticasone furoate–vilanterol safe, effective treatment for COPD

Patients with chronic obstructive pulmonary disease treated with a combination of fluticasone furoate and vilanterol had a significant reduction of exacerbations with no increase of serious adverse events compared with usual care, according to recent study findings.

“Guidelines on the management of chronic obstructive pulmonary disease (COPD) are based on numerous randomized, controlled trials of efficacy, which are usually generated for registration purposes. However, these trials have included patients who were selected with the use of strict criteria and were closely monitored, and therefore the results have limited relevance to everyday clinical practice,” Jørgen Vestbo, DMSc, of University of Manchester and University Hospital of South Manchester NHS Foundation Trust, and colleagues wrote.

Vestbo and colleagues enrolled a real-world population of 2,799 patients with COPD and a history of exacerbations from 75 general practices in the Salford Lung Study to unobtrusively monitor the safety and efficacy of combined fluticasone furoate and vilanterol compared with usual care. Participants were randomized to receive either a combined once-daily inhaled dose of 100 μg of fluticasone furoate and 25 μg of vilanterol or an existing maintenance therapy.

Results showed that the fluticasone furoate–vilanterol group had an 8.4% lower rate of moderate or severe exacerbations (95% confidence interval, 1.1 to 15.2) than the usual care group (P = 0.02).

The annual rate of primary or secondary care visits for COPD–related incidences were similar in both groups. In addition, time-to-event analysis revealed that the rates of the initial moderate or severe exacerbation and the initial severe exacerbation were also similar in both groups.

Patients receiving the combination of fluticasone furoate and vilanterol did not show signs of excess serious adverse events of pneumonia. Overall, both groups had similar rates of all other serious adverse events.

“This trial shows that broad populations of patients with COPD benefit from treatment with fluticasone furoate–vilanterol,” Vestbo and colleagues concluded. “Future effectiveness studies are likely to influence clinical guidelines, not only for COPD but for many other chronic diseases.” – by Alaina Tedesco

Disclosure: The researchers report that this study was funded by GlaxoSmithKline.