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FLAME
Indacaterol–Glycopyrronium versus Salmeterol–Fluticasone for COPD
Jadwiga A. Wedzicha, M.D., Donald Banerji, M.D., Kenneth R. Chapman, M.D., Jørgen Vestbo, M.D., D.M.Sc., Nicolas Roche, M.D., R. Timothy Ayers, M.Sc., Chau Thach, Ph.D., Robert Fogel, M.D., Francesco Patalano, M.D., and Claus F. Vogelmeier, M.D., for the FLAME Investigators* N Engl J Med 2016 - Publication avancée en ligne le 15 mai 2016.

Indacatérol-glycopyrronium (cf infra) était plus efficace que le salmétérol-fluticasone (cf infra) dans la prévention des exacerbations de BPCO chez les patients ayant des antécédents d'exacerbation au cours de l'année précédente.
L'étude FLAME a été financée par Novartis, le fabricant de l'indacatérol-glycopyrronium.
A suivre...

BACKGROUND
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.

    indacatérol
  • HIROBRIZ BREEZHALER poudre pour inhalation en gélule 150 et 300 µg,
  • ONBREZ BREEZHALER poudre pour inhalation en gélule 150 et 300 µg
  • OSLIF BREEZHALER poudre pour inhalation en gélule 150 et 300 µg

    glycopyrronium bromure
  • SEEBRI BREEZHALER poudre pour inhalation en gélule 44 mcg

    salmétérol
  • SEREVENT suspension pour inhalation en flacon pressurisé 25 mcg/dose
  • SEREVENT DISKUS poudre pour inhalation 50 mcg/dose

    fluticasone
  • FLIXOTIDE suspension pour inhalation en flacon pressurisé 50,125 et 250 µg/dose
  • FLIXOTIDE DISKUS poudre pour inhalation, voie buccale 100, 250 et 500 µg/dose

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