The Informing the Pathway of COPD Treatment (IMPACT) trial, now reported in the The New England Journal of Medicine,
aims to fill this gap with a report on the effectiveness of
LAMA–LABA–inhaled glucocorticoid treatment, contained in a single
inhaler, in COPD.
Background
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), are uncertain.
Methods
In this
randomized trial involving 10,355 patients with COPD, we compared 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
primary outcome was the annual rate of moderate or severe COPD exacerbations
during treatment.
Results
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). The annual rate of severe
exacerbations resulting in 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). There was a higher
incidence of pneumonia in the inhaled-glucocorticoid groups than in the
umeclidinium–vilanterol group, and the risk of clinician-diagnosed pneumonia
was significantly higher with triple therapy than with umeclidinium–vilanterol,
as assessed in a time-to-first-event analysis (hazard ratio, 1.53; 95% CI, 1.22
to 1.92; P<0.001).
Conclusions
Triple
therapy with fluticasone furoate, umeclidinium, and vilanterol resulted in a
lower rate of moderate or severe COPD exacerbations than fluticasone
furoate–vilanterol or umeclidinium–vilanterol in this population. Triple
therapy also resulted in a lower rate of hospitalization due to COPD than
umeclidinium–vilanterol.
full text:
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