Best Evidence Analyses and Commentary

Effectiveness of vilanterol/fluticasone furoate as once daily dosing in COPD patients
Wycliffe Mugoya, PharmD Candidate; Marcus Campbell, PharmD, BC-ADM, Ryan Wargo, PharmD, BCACP
November 2013

Recently, FDA approved GlaxoSmithKline’s Breo Ellipta; an inhaled corticosteroid and long-acting beta agonist (ICS/LABA) combination product for long-term maintenance therapy in COPD patients. Breo Ellipta contains 100 mcg of fluticasone furoate and 25 mcg of vilanterol, which is administered via dry powder inhaler once daily. Prior to Breo Ellipta, the only ICS/LABA combination products (Advair® and Symbicort®) required twice daily dosing; this prompted research for a once daily alternative to reduce patient burden and improve compliance. Approval of the new product was based on several dose-ranging trials and four confirmatory trials in subjects with COPD.3  Including two, 24-week, randomized, double-blind, placebo-controlled trials designed to evaluate the effects on lung function of fluticasone furoate and vilanterol (FF/VI) combination in comparison to single ingredient fluticasone fuoroate, vilanterol, and placebo were conducted (Table 1). 

In addition two, randomized, double-blind, 52-week trials designed to evaluate the effect of FF/VI on the rate of moderate and severe COPD exacerbations were conducted.  After completing a run-in phase, patients were assigned to take FF/VI 100/25 mcg, FF/VI 200/25 mcg, FF/VI 50/25 mcg, or vilanterol 25 mcg.  The primary endpoint for both trials was annual rate of moderate or severe exacerbations of COPD.  Exacerbations were considered moderate if treatment with systemic corticosteroids and/or antibiotics was required and were considered to be severe if hospitalization was required. In both trials patients with FF/VI 100/25 mcg had a lower annual rate of moderate/severe COPD exacerbations compared with vilanterol alone.3 The safety and efficacy of Breo Ellipta has been evaluated in 7,700 subjects with COPD.3

A major barrier to effective COPD management is patient compliance making the arrival of a once-daily treatment an attractive option for healthcare providers.  The most common adverse effects associated with Breo Ellipta include nasopharyngitis, upper respiratory tract infections, headache, and oral candidiasis.3 Serious adverse events include pneumonia and reduction in bone mineral density.3 Breo Ellipta carries the same black box warning as other long-acting beta agonists regarding an increase in the risk for asthma related deaths.  As a result, Breo Ellipta is not indicated for the treatment of asthma. 

The addition of a once-daily ICS/LABA combination inhaler is a positive advancement in the treatment of COPD.  It offers an alternative to existing twice-daily products that are currently first line agents for treatment of patients at high risk for COPD exacerbation based on current GOLD guidelines.1

 

 

 References:

1.  Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) Updated 2013. Available from: http://www.goldcopd.org/

2.  National Heart Lung and Blood Institute. “November Is National COPD Awareness Month”.<http://www.nhlbi.nih.gov/health/public/lung/copd/event-listing/awareness-month/materials-resources.htm>. Accessed on 17 Aug 2013.

3. Breo Ellipta [package insert]. Research Triangle Park, NC 27709. GlaxoSmithKline; 2013.

 

 

 


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