Dear Respiratory Friends great news come from NEJM about dual bronchodilators in COPD!
Most guidelines recommend either a long-acting
beta-agonist (LABA) plus an inhaled glucocorticoid or a long-acting
muscarinic antagonist (LAMA) as the first-choice treatment for patients
with chronic obstructive pulmonary disease (COPD) who have a high risk
of exacerbations. The role of treatment with a LABA–LAMA regimen in
these patients is unclear.
Methods
We conducted a 52-week, randomized, double-blind, double-dummy, noninferiority trial. Patients who had COPD with a history of at least one exacerbation during the previous year were randomly assigned to receive, by inhalation, either the LABA indacaterol (110 μg) plus the LAMA glycopyrronium (50 μg) once daily or the LABA salmeterol (50 μg) plus the inhaled glucocorticoid fluticasone (500 μg) twice daily. The primary outcome was the annual rate of all COPD exacerbations.Results
A
total of 1680 patients were assigned to the indacaterol–glycopyrronium
group, and 1682 to the salmeterol–fluticasone group.
Indacaterol–glycopyrronium showed not only noninferiority but also
superiority to salmeterol–fluticasone in reducing the annual rate of all
COPD exacerbations; the rate was 11% lower in the
indacaterol–glycopyrronium group than in the salmeterol–fluticasone
group (3.59 vs. 4.03; rate ratio, 0.89; 95% confidence interval [CI],
0.83 to 0.96; P=0.003). The indacaterol–glycopyrronium group had a
longer time to the first exacerbation than did the
salmeterol–fluticasone group (71 days [95% CI, 60 to 82] vs. 51 days
[95% CI, 46 to 57]; hazard ratio, 0.84 [95% CI, 0.78 to 0.91],
representing a 16% lower risk; P<0.001). The annual rate of moderate
or severe exacerbations was lower in the indacaterol–glycopyrronium
group than in the salmeterol–fluticasone group (0.98 vs. 1.19; rate
ratio, 0.83; 95% CI, 0.75 to 0.91; P<0.001), and the time to the
first moderate or severe exacerbation was longer in the
indacaterol–glycopyrronium group than in the salmeterol–fluticasone
group (hazard ratio, 0.78; 95% CI, 0.70 to 0.86; P<0.001), as was the
time to the first severe exacerbation (hazard ratio, 0.81; 95% CI, 0.66
to 1.00; P=0.046). The effect of indacaterol–glycopyrronium versus
salmeterol–fluticasone on the rate of COPD exacerbations was independent
of the baseline blood eosinophil count. The incidence of adverse events
and deaths was similar in the two groups. The incidence of pneumonia
was 3.2% in the indacaterol–glycopyrronium group and 4.8% in the
salmeterol–fluticasone group (P=0.02).
Conclusions
Indacaterol–glycopyrronium
was more effective than salmeterol–fluticasone in preventing COPD
exacerbations in patients with a history of exacerbation during the
previous year.
full text from todays NEJM:
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