Effectiveness of Fluticasone Furoate–Vilanterol for COPD in Clinical Practice

Garrett Brown, Mercer University College of Pharmacy

Inhaled corticosteroids have proven benefits for people with worsening symptoms of chronic obstructive pulmonary disease (COPD) and repeated exacerbations. Currently marketed products use corticosteroids in combination with long-acting beta2-agonists (LABA).  Inhaled corticosteroids have been shown to reduce exacerbation rates, all-cause mortality, and to improve lung function and quality of life.  [1]

In May 2013 the U.S. Food and Drug Administration approved Breo Ellipta® (fluticasone furoate and vilanterol inhalation powder) as long-term maintenance treatment of COPD.  [2]

According to the Global Initiative for Chronic Obstructive Lung Disease Guidelines, the mainstay of therapy for COPD is a LABA or long-acting anti-muscarinic (LAMA).  Inhaled corticosteroids are recommended for patients with frequent exacerbation episodes.  [3]

Effectiveness of Fluticasone Furoate–Vilanterol for COPD in Clinical Practice [4]

 

Design Multicenter, prospective, open-label, parallel-group, randomized trial; N= 2799
Objective To evaluate the effectiveness and safety of inhaled combination of fluticasone furoate-vilanterol compared to existing maintenance therapy in patients with COPD
Study Groups Fluticasone furoate- vilanterol (n= 1291); existing maintenance or usual care (n= 1309)
Methods Patients were included if they were older than 40 yrs old, diagnosed with COPD, and had one or more COPD exacerbations in the previous 3 years. Patients had to be taking regular maintenance inhaler therapy, defined as the use of one or more long-acting bronchodilators or inhaled glucocorticoids alone or in combination with a LAMA or LABA.  Patients were randomly assigned to combination therapy with fluticasone furoate- vilanterol 100-25 ug or continuation of usual care.  Assessment was done at months three, six, nine, and 12.  The primary effectiveness analysis population was comprised of 2,269 patients who had one or more moderate to severe exacerbations in the year before the trial.
Duration March 13th, 2012 – October 23rd, 2014
Primary Outcome Measure The rate of moderate or severe exacerbations among patients who had an exacerbation within 1 year before the trial
Baseline Characteristics
Trial Population Usual care group Fluticasone furoate- vilanterol group Primary Effectiveness analysis group
Average age, yrs 67 67 67 67
Female, n (%) 1369 (49) 671 (48) 698 (50) 1122 (49)
Current smoker, n (%) 1289 (46) 666 (47) 623 (45) 1046 (46)
Average FEV-1, liters 1.62 1.62 1.62 1.59
Number of exacerbations in previous 12 months, avg 2.01 2.04 1.98 2.48
Results  

Fluticasone furoate-vilanterol group Usual care group
Rate of moderate or severe exacerbations per year, n 1.74 1.90

 

Percent Difference, % 8.4
Confidence interval 95% 1.1-15.2
p-value p= 0.02
Adverse Events Common Adverse Events: None reported
Serious Adverse Events: pneumonia (7%), cardiovascular event (8%), death (2%)
Percentage that Discontinued due to Adverse Events: None reported
Study Author Conclusions Patients who had a diagnosis of COPD and a heightened risk of exacerbations had a benefit with fluticasone furoate- vilanterol, without an additional risk of serious adverse events.

 

The strengths of the study include broad inclusion criteria and a focus on COPD patients with moderate to severe exacerbations.  The lack of substantial exclusion criteria led to many patients with asthma being included in the data.  A weakness of the trial was the lack of treatment blinding, which may have introduced bias and led to the large degree of treatment switching from fluticasone group to the usual-care group.

 

At a cost of $140 per 28 blister packs, fluticasone furoate- vilanterol is a substantial cost for patients compared to other generics on the market. [5] The therapeutic benefit of using fluticasone furoate- vilanterol is not clinically significant, making it difficult to justify such an increase to a patient’s prescription costs.

 

References

  1. Kew KM, Seniukovich A. Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2014;(3):CD010115.
  2. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm351664.htm. Accessed September 28, 2016.
  3. Global Initiative for Chronic Obstructive Lung Disease. http://goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. Accessed September 14, 2016.
  4. Vestbo J, Leather D, Diar bakerly N, et al. Effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice. N Engl J Med. 2016.
  5. Lexicomp Online® , Pediatric & Neonatal Lexi-Drugs® , Hudson, Ohio: Lexi-Comp, Inc.; Accessed on September 29, 2016.
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