Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Efficacy of Fluticasone Furoate-Vilanterol for COPD
N Engl J Med; ePub 2016 Sep 4; Vestbo, et al
A once-daily treatment regimen of combined fluticasone furoate and vilanterol was associated with a lower rate of exacerbations than usual care, and without a great risk of serious adverse events, in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations, a recent study found. In a controlled trial conducted in 75 general practices, 2,799 patients with COPD were randomly assigned to a once-daily inhaled combination of fluticasone furoate (100 µg) and vilanterol (25 µg) or to usual care. Researchers found:
- Rate of moderate or severe exacerbations was significantly lower by 8.4%, with fluticasone furoate-vilanterol therapy vs usual care.
- There were no significant between-group differences in the rates of the first moderate or severe exacerbation and the first severe exacerbation in the time-to-event analyses.
- No excess serious adverse events of pneumonia occurred in the fluticasone furoate-vilanterol group.
10.1056/NEJMoa1608033.
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Electronically Delivered Interventions in Antibiotic Rx, BMJ; ePub 2019 Feb 13; Gulliford, et al
Physician Care for Patients with COPD, CHEST; ePub 2019 Jan 18; Cho, Mecredy, et al
This study used a novel methodology, real-world randomization, to show that in a real-world setting, once-daily fluticasone furoate-vilanterol (Breo, in the US) was more effective in decreasing exacerbation rates in patients with COPD who had 1 or more COPD exacerbations in the previous 3 years than usual care. Average FEV-1 in these patients was 1.6 L. The methodology was novel because unlike the randomized trials that we are used to seeing, the intervention of interest here is not tested against placebo or a specific other drug, but rather against the array of drugs used in usual care. As a real world study, this may better reflect attributes of the drug such as ease of use, tolerability, and the effect of once daily administration on adherence better than a randomized trial. The challenge is that one needs to be careful in the interpretation of the results as the medication is not tested against one specific other intervention, but rather against LABAs, LAMAs, and combination therapy. That said, the once daily ICS-LABA combination of fluticasone furoate-vilanterol perfomed better than the aggregate of usual care in this real-world setting. —Neil Skolnik, MD