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DOI: 10.1055/s-0037-1619355
Once-daily indacaterol/glycopyrronium reduces the rate and risk of moderate or severe exacerbations compared with twice-daily salmeterol/fluticasone in a subset of gold froup D COPD patients with a history of >= 2 exacerbations or 1 hospitalization: the FLAME study
Publication History
Publication Date:
21 February 2018 (online)
Introduction:
One of the major goals of COPD treatment is to reduce the severity and frequency of exacerbations.1 Patients categorized into Global Initiative for Chronic Obstructive Lung Disease (GOLD) Group D have severe-to-very severe airflow limitation, and/or exacerbations, and significant symptoms.1 LABA/ICS or/and a LAMA are recommended as the first choice treatment for Group D patients.1 FLAME was the first study that demonstrated the superiority of indacaterol/glycopyrronium (IND/GLY), a LABA/LAMA combination, in reducing exacerbations, improving lung function, and health status versus salmeterol/fluticasone (SAL/FLU), a LABA/ICS combination, in moderate-to-very severe COPD patients with a history of exacerbations.2 Here, we present a subset analysis of GOLD Group D patients who had a history of ≥2 exacerbations or 1 hospitalization for exacerbation. Effects of IND/GLY vs. SAL/FLU on the rate and risk of moderate or severe exacerbations were compared.
Methods:
FLAME was a 52-week, randomized, double-blind, double-dummy, parallel-group study. 3362 patients with moderate-to-very severe COPD, post-bronchodilator FEV1 ≥25% to < 60% of the predicted normal, and a history of ≥1 exacerbation in the previous year were randomized (1:1) to receive either IND/GLY (110/50 µg) once daily or SAL/FLU (50/500 µg) twice daily. The rate and time to moderate or severe exacerbations were analyzed in the subset of GOLD Group D patients with a history of ≥2 exacerbations or 1 hospitalization.
Results:
IND/GLY demonstrated superior efficacy over SAL/FLU in reducing the rate of moderate or severe exacerbations (rate ratio, 0.86; Table). IND/GLY delayed the time-to-first moderate or severe exacerbation compared with SAL/FLU (median days: 291 vs. 215; Table). The patients treated with IND/GLY had a 19% lower risk of a moderate or severe exacerbation compared with SAL/FLU.
Annualized rate |
||
Indacaterol/glycopyrronium (n = 531) |
Salmeterol/fluticasone (n = 503) |
|
Rate (95% CI) |
1.26 (1.06 to 1.51) |
1.47 (1.24 to 1.75) |
Rate ratio* (95% CI) |
0.86 (0.74 to 1.00) |
|
P value |
0.05 |
|
Time-to-first exacerbation |
||
Indacaterol/glycopyrronium (n = 536) |
Salmeterol/fluticasone (n = 511) |
|
Patients with event, n (%) |
281 (52.4) |
299 (58.5) |
Patients without event, n (%) |
255 (47.6) |
212 (41.5) |
Time at risk (days), median (range) |
247.5 (1 to 419) |
181 (2 to 386) |
Time-to-event (days), median (95% CI) |
291 (254 to 352) |
215 (175 to 261) |
Hazard ratio* (95% CI) |
0.81 (0.69 to 0.96) |
|
P value |
0.013 |
|
* indacaterol/glycopyrronium versus salmeterol/fluticasone |
Conclusions:
IND/GLY was superior to SAL/FLU in reducing the rate and risk of moderate or severe exacerbations in a subset of GOLD Group D patients who had a history of ≥2 exacerbations or 1 hospitalization for exacerbation. Our results confirm the use of IND/GLY as a preferred treatment option for COPD patients at high risk of exacerbations.
References:
[1] GOLD 2016. Available from: www.goldcopd.org
[2] Wedzicha JA et al. N Engl J Med. 2016;374(23):2222 – 2234
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