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Indacaterol/glycopyrronium versus salmeterol/fluticasone in Asian patients with COPD at a high risk of exacerbations: results from the FLAME study.
Int J Chron Obstruct Pulmon Dis. 2017; 12:339-349.IJ

Abstract

BACKGROUND

The FLAME study demonstrated that indacaterol/glycopyrronium (IND/GLY), the fixed-dose combination of a long-acting β2-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 AND METHODS

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 [FEV1] and forced vital capacity [FVC]), health status (St George's Respiratory Questionnaire [SGRQ]), rescue medication use, and safety.

RESULTS

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; P=0.027) and prolonged time to first moderate/severe exacerbation versus SFC (hazard ratio: 0.77; 95% confidence interval: 0.59-1.01; P=0.055). Predose trough FEV1 and FVC significantly improved in Asian patients (P<0.001). IND/GLY improved SGRQ for COPD (SGRQ-C score; P=0.006) and reduced rescue medication use (P=0.058) at week 52. Pneumonia incidence was 3.6% with IND/GLY and 7.7% with SFC (P=0.046).

CONCLUSION

In exacerbating Asian COPD patients, IND/GLY was more effective than SFC.

Authors+Show Affiliations

National Heart and Lung Institute, Imperial College London, London, UK.State Key Laboratory of Respiratory Disease, National Clinical Research Center of Respiratory Disease, Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, People's Republic of China.Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.Beijing Novartis Pharma Co. Ltd., Shanghai, People's Republic of China.Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.Novartis Pharma AG, Basel, Switzerland.Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28176893

Citation

Wedzicha, Jadwiga A., et al. "Indacaterol/glycopyrronium Versus Salmeterol/fluticasone in Asian Patients With COPD at a High Risk of Exacerbations: Results From the FLAME Study." International Journal of Chronic Obstructive Pulmonary Disease, vol. 12, 2017, pp. 339-349.
Wedzicha JA, Zhong N, Ichinose M, et al. Indacaterol/glycopyrronium versus salmeterol/fluticasone in Asian patients with COPD at a high risk of exacerbations: results from the FLAME study. Int J Chron Obstruct Pulmon Dis. 2017;12:339-349.
Wedzicha, J. A., Zhong, N., Ichinose, M., Humphries, M., Fogel, R., Thach, C., Patalano, F., & Banerji, D. (2017). Indacaterol/glycopyrronium versus salmeterol/fluticasone in Asian patients with COPD at a high risk of exacerbations: results from the FLAME study. International Journal of Chronic Obstructive Pulmonary Disease, 12, 339-349. https://doi.org/10.2147/COPD.S125058
Wedzicha JA, et al. Indacaterol/glycopyrronium Versus Salmeterol/fluticasone in Asian Patients With COPD at a High Risk of Exacerbations: Results From the FLAME Study. Int J Chron Obstruct Pulmon Dis. 2017;12:339-349. PubMed PMID: 28176893.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Indacaterol/glycopyrronium versus salmeterol/fluticasone in Asian patients with COPD at a high risk of exacerbations: results from the FLAME study. AU - Wedzicha,Jadwiga A, AU - Zhong,Nanshan, AU - Ichinose,Masakazu, AU - Humphries,Michael, AU - Fogel,Robert, AU - Thach,Chau, AU - Patalano,Francesco, AU - Banerji,Donald, Y1 - 2017/01/19/ PY - 2017/2/9/entrez PY - 2017/2/9/pubmed PY - 2017/10/11/medline KW - Asia KW - bronchodilator agents KW - chronic obstructive pulmonary disease KW - exacerbations KW - indacaterol/glycopyrronium SP - 339 EP - 349 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 12 N2 - BACKGROUND: The FLAME study demonstrated that indacaterol/glycopyrronium (IND/GLY), the fixed-dose combination of a long-acting β2-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 AND METHODS: 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 [FEV1] and forced vital capacity [FVC]), health status (St George's Respiratory Questionnaire [SGRQ]), rescue medication use, and safety. RESULTS: 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; P=0.027) and prolonged time to first moderate/severe exacerbation versus SFC (hazard ratio: 0.77; 95% confidence interval: 0.59-1.01; P=0.055). Predose trough FEV1 and FVC significantly improved in Asian patients (P<0.001). IND/GLY improved SGRQ for COPD (SGRQ-C score; P=0.006) and reduced rescue medication use (P=0.058) at week 52. Pneumonia incidence was 3.6% with IND/GLY and 7.7% with SFC (P=0.046). CONCLUSION: In exacerbating Asian COPD patients, IND/GLY was more effective than SFC. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/28176893/Indacaterol/glycopyrronium_versus_salmeterol/fluticasone_in_Asian_patients_with_COPD_at_a_high_risk_of_exacerbations:_results_from_the_FLAME_study_ DB - PRIME DP - Unbound Medicine ER -