Indacaterol/glycopyrronium versus salmeterol/fluticasone in Asian patients with COPD at a high risk of exacerbations: results from the FLAME study

• Published in: International journal of chronic obstructive pulmonary disease Vol. 12; pp. 339 - 349
• Main Authors: Wedzicha, Jadwiga A, Zhong, Nanshan, Ichinose, Masakazu, Humphries, Michael, Fogel, Robert, Thach, Chau, Patalano, Francesco, Banerji, Donald
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2017; Dove Medical Press Ltd; Dove Medical Press
• Subjects: Adrenergic beta-2 Receptor Agonists - administration & dosage; Adrenergic beta-2 Receptor Agonists - adverse effects; Aged; Antibiotics; Asia; Asia - epidemiology; Asians; Body mass index; bronchodilator agents; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; Chronic obstructive lung disease; Chronic obstructive pulmonary disease; Clinical medicine; Combination drug therapy; Comparative analysis; Cultural differences; Development and progression; Disease Progression; Double-Blind Method; Drug dosages; Drug therapy; exacerbations; Female; Fluticasone-Salmeterol Drug Combination - administration & dosage; Fluticasone-Salmeterol Drug Combination - adverse effects; Forced Expiratory Volume; Glycopyrrolate - administration & dosage; Glycopyrrolate - adverse effects; Health Status; Hospitalization; Humans; indacaterol/glycopyrronium; Indans - administration & dosage; Indans - adverse effects; Lung - drug effects; Lung - physiopathology; Male; Middle Aged; Mortality; Muscarinic Antagonists - administration & dosage; Muscarinic Antagonists - adverse effects; Original Research; Patients; Pneumonia; Population; Pulmonary Disease, Chronic Obstructive - diagnosis; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - ethnology; Pulmonary Disease, Chronic Obstructive - physiopathology; Quinolones - administration & dosage; Quinolones - adverse effects; Recovery of Function; Steroids; Surveys and Questionnaires; Time Factors; Treatment Outcome; Vital Capacity; Asia; bronchodilator agents; Asia; exacerbations; chronic obstructive pulmonary disease; indacaterol/glycopyrronium
• ISSN: 1178-2005; 1176-9106; 1178-2005
• DOI: 10.2147/COPD.S125058

The FLAME study demonstrated that indacaterol/glycopyrronium (IND/GLY), the fixed-dose combination of a long-acting β -agonist (LABA, IND) and a long-acting muscarinic antagonist (LAMA, GLY), was superior to salmeterol/fluticasone combination (SFC) in preventing exacerbations in COPD patients with a high risk of exacerbations. In this study, we report a prespecified analysis of the efficacy and safety of IND/GLY versus SFC in Asian patients from the FLAME study. Patients from Asian centers with moderate-to-very severe COPD and ≥1 exacerbation in the previous year from the 52-week, randomized FLAME study were included. IND/GLY was compared versus SFC for effects on exacerbations, lung function (forced expiratory volume in 1 second [FEV ] and forced vital capacity [FVC]), health status (St George's Respiratory Questionnaire [SGRQ]), rescue medication use, and safety. A total of 510 Asian patients (IND/GLY, n=250 or SFC, n=260) were included. Compared to the overall FLAME population, the Asian cohort had more males, a shorter duration of COPD, fewer patients using inhaled corticosteroid (ICS) at screening, fewer current smokers, and more patients with very severe COPD. IND/GLY significantly reduced the rate of moderate/severe exacerbations (rate ratio: 0.75; 95% confidence interval: 0.58-0.97; =0.027) and prolonged time to first moderate/severe exacerbation versus SFC (hazard ratio: 0.77; 95% confidence interval: 0.59-1.01; =0.055). Predose trough FEV and FVC significantly improved in Asian patients ( <0.001). IND/GLY improved SGRQ for COPD (SGRQ-C score; =0.006) and reduced rescue medication use ( =0.058) at week 52. Pneumonia incidence was 3.6% with IND/GLY and 7.7% with SFC ( =0.046). In exacerbating Asian COPD patients, IND/GLY was more effective than SFC.