Study to Understand Mortality and MorbidITy - SUMMIT

Jun 06, 2016
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
GlaxoSmithKline
Date Published:
04/30/2016
Original Posted Date:
06/06/2016
References

Description:

The goal of the trial was to evaluate treatment with a corticosteroid and long-acting β agonist among patients with chronic obstructive pulmonary disease (COPD) and increased cardiovascular risk.

Contribution to the Literature: The SUMMIT trial failed to show that a corticosteroid and long-acting β agonist improved survival in moderate COPD.

Study Design

  • Randomized
  • Parallel
  • Placebo

Patients with moderate COPD were randomized to fluticasone furoate (100 μg) (n = 4,157), vilanterol (25 μg) (n = 4,140), the combination of fluticasone furoate and vilanterol (n = 4,140), or placebo (n = 4,131).

  • Total number of enrollees: 16,568
  • Duration of follow-up: maximum 4 years, median 1.8 years
  • Mean patient age: 65 years
  • Percentage female: 25%
  • Percentage diabetics: 27%

Inclusion criteria:

  • Patients 40-80 years of age with moderate COPD
  • Forced expiratory volume in 1 second (FEV1) 50-70%, FEV1/forced vital capacity (FVC) ≤0.7, smoking history ≥10 pack-years, and score ≥2 on modified Medical Research Council dyspnea scale
  • History of, or increased risk of, cardiovascular disease

Exclusion criteria:

  • Respiratory disorders other than COPD
  • Lung reduction surgery
  • Use of long-term oxygen or oral corticosteroid therapy
  • Severe heart failure (New York Heart Association class IV or ejection fraction <30%)
  • Life expectancy <3 years
  • End-stage chronic renal disease

Principal Findings:

The primary outcome, incidence of all-cause mortality, occurred in 6.1% of the fluticasone furoate group (p = 0.28 vs. placebo), 6.4% of the vilanterol group (p = 0.66 vs. placebo), 6.0% of the combination fluticasone and vilanterol group (p = 0.14 vs. placebo), and 6.7% with placebo.

Secondary outcomes:

  • FEV1 decline: 38 ml per year in the fluticasone furoate group (p = 0.026 vs. placebo), 47 ml per year in the vilanterol group (p = 0.65), 38 ml per year in the combination treatment group (p = 0.019), and 46 ml per year in the placebo group
  • Percent reduction in moderate and severe exacerbations: 12% for the fluticasone furoate group (p = 0.004 vs. placebo), 10% for the vilanterol group (p = 0.017 vs. placebo), and 29% for the combination group (p < 0.0001 vs. placebo)

Interpretation:

Among patients with moderate COPD, fluticasone furoate (alone or in combination with vilanterol) was associated with a reduction in the rate of decline in FEV1 and a reduction in moderate and severe exacerbations. Despite a study cohort enriched for cardiovascular risk, none of the study medications was associated with a reduction in mortality.

References:

Vestbo J, Anderson JA, Brook RD, et al., on behalf of the SUMMIT Investigators. Fluticasone furoate and vilanterol and survival in chronic obstructive pulmonary disease with heightened cardiovascular risk (SUMMIT): a double-blind randomised controlled trial. Lancet 2016;387:1817-26.

Keywords: Cardiovascular Diseases, Forced Expiratory Volume, Ischemia, Mortality, Pulmonary Disease, Chronic Obstructive, Risk Factors, Secondary Prevention, Smoking, Treatment Outcome, Vital Capacity


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