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Once-daily single-inhaler triple vs dual therapy in patients with COPD

New England Journal of Medicine Apr 26, 2018

Lipson DA, et al. - Researchers undertook an exploration of the benefits of triple therapy for chronic obstructive pulmonary disease (COPD) with an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA), and a long-acting β2-agonist (LABA), as compared with dual therapy (either inhaled glucocorticoid–LABA or LAMA–LABA). Data displayed a lower rate of moderate or severe COPD exacerbations due to triple therapy with fluticasone furoate, umeclidinium, and vilanterol compared to fluticasone furoate–vilanterol or umeclidinium-vilanterol. Additionally, it was inferred that triple therapy led to a lower rate of hospitalization as a result of COPD than umeclidinium–vilanterol.

Methods

  • This study included 10,355 patients with COPD.
  • A comparison was performed of 52 weeks of a once-daily combination of fluticasone furoate (an inhaled glucocorticoid) at a dose of 100 μg, umeclidinium (a LAMA) at a dose of 62.5 μg, and vilanterol (a LABA) at a dose of 25 μg (triple therapy) with fluticasone furoate-vilanterol (at doses of 100 μg and 25 μg, respectively) and umeclidinium-vilanterol (at doses of 62.5 μg and 25 μg, respectively).
  • Each regimen was administered in a single Ellipta inhaler.
  • The annual rate of moderate or severe COPD exacerbations during treatment served as the primary outcome.

Results

  • It was determined that the rate of moderate or severe exacerbations in the triple-therapy group was 0.91 per year, as compared with 1.07 per year in the fluticasone furoate-vilanterol group (rate ratio with triple therapy, 0.85; 95% confidence interval [CI], 0.80 to 0.90; 15% difference; P < 0.001) and 1.21 per year in the umeclidinium-vilanterol group (rate ratio with triple therapy, 0.75; 95% CI, 0.70 to 0.81; 25% difference; P < 0.001).
  • As per the data, the annual rate of severe exacerbations leading to hospitalization in the triple-therapy group was 0.13, as compared with 0.19 in the umeclidinium-vilanterol group (rate ratio, 0.66; 95% CI, 0.56 to 0.78; 34% difference; P < 0.001).
  • A higher incidence of pneumonia was reported in the inhaled-glucocorticoid groups compared to the umeclidinium-vilanterol group.
  • A substantially higher risk of clinician-diagnosed pneumonia was discovered with triple therapy than with umeclidinium-vilanterol, determined via a time-to-first-event analysis (hazard ratio, 1.53; 95% CI, 1.22 to 1.92; P < 0.001).

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