Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: A 12-week study

被引:70
作者
Korn, Stephanie [2 ]
Kerwin, Edward [3 ]
Atis, Sibel [4 ]
Amos, Carolynn [1 ]
Owen, Roger [1 ]
Lassen, Cheryl [1 ]
机构
[1] Novartis Horsham Res Ctr, Horsham RH12 5AB, W Sussex, England
[2] Mainz Univ Hosp, Dept Pulm, Mainz, Germany
[3] Clin Res Inst So Oregon, Medford, OR USA
[4] Mersin Univ, Mersin, Turkey
关键词
beta2-agonist; Bronchodilator; COPD; Indacaterol; Salmeterol; OBSTRUCTIVE PULMONARY-DISEASE; TIOTROPIUM; BRONCHODILATORS; MANAGEMENT; DYSPNEA; INDEX;
D O I
10.1016/j.rmed.2011.02.008
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background: Indacaterol is a novel, inhaled once-daily ultra-long-acting beta(2)-agonist for the treatment of COPD. Methods: This 12-week randomised, parallel-group study compared the efficacy of indacaterol 150 mu g once-daily to salmeterol 50 mu g twice-daily in patients with moderate-to-severe COPD. Assessments included FEV(1) standardised area under curve (AUC) from 5 min to 11 h 45 min at Week 12 (primary endpoint), 24-h trough FEV(1) (mean of 23 h 10 min and 23 h 45 min post-dose) at Week 12 (key secondary endpoint), FEV(1) and FVC measured over 24-h, transition dyspnoea index (TDI) and rescue medication use. Results: Of 1123 patients randomised 92.1% completed. Mean +/- SD age was 62.8 +/- 8.78 years, post-bronchodilator FEV(1) 51.8 +/- 12.32% predicted, FEV(1)/FVC 50.6 +/- 9.54%. At Week 12, FEV(1) AUC(5 min-11 h 45 min) for indacaterol was statistically superior (p < 0.001) to salmeterol (adjusted mean difference [95% CI] 57 [35, 79] mL), as was 24-h trough FEV(1) (60 [37, 83] mL, p < 0.001). Indacaterol also showed statistical superiority over salmeterol in terms of FEV(1) and FVC measured over 24-h at Week 12. For TDI at Week 12, the mean total score was statistically superior for indacaterol versus salmeterol (difference 0.63 [0.30, 0.97], p < 0.001), as was the percentage of patients with a clinically relevant (i.e., >= 1 point) change from baseline (69.4% vs 62.7%, p < 0.05). For rescue medication, patients on indacaterol used fewer puffs/day (difference -0.18 [-0.36, 0.00] puffs/day, p < 0.05) and had a greater percentage of days with no rescue use (difference 4.4 [0.6, 8.2], p < 0.05). Conclusion: Once-daily indacaterol provided statistically superior bronchodilation with an improvement in breathlessness and rescue use compared with twice-daily salmeterol. ClinicalTrials.gov NCT00821093 (C) 2011 Elsevier Ltd. All rights reserved.
引用
收藏
页码:719 / 726
页数:8
相关论文
共 22 条
[1]  
[Anonymous], 2009, Global Strategy for the diagnosis, management and prevention of Chronic Obstructive Lung Disease
[2]  
[Anonymous], 2007, GLOBAL STRATEGY DIAG
[3]   Patient adherence in COPD [J].
Bourbeau, J. ;
Bartlett, S. J. .
THORAX, 2008, 63 (09) :831-838
[4]   Effect of tiotropium bromide on circadian variation in airflow limitation in chronic obstructive pulmonary disease [J].
Calverley, PMA ;
Lee, A ;
Towse, L ;
van Noord, J ;
Witek, TJ ;
Kelsen, S .
THORAX, 2003, 58 (10) :855-860
[5]   Ultra long-acting β2-agonists in development for asthma and chronic obstructive pulmonary disease [J].
Cazzola, M ;
Matera, MG ;
Lötvall, J .
EXPERT OPINION ON INVESTIGATIONAL DRUGS, 2005, 14 (07) :775-783
[6]   The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease [J].
Celli, BR ;
Cote, CG ;
Marin, JM ;
Casanova, C ;
de Oca, MM ;
Mendez, RA ;
Pinto Plata, V ;
Cabral, HJ .
NEW ENGLAND JOURNAL OF MEDICINE, 2004, 350 (10) :1005-1012
[7]   Treatment persistence and compliance with medications for chronic obstructive pulmonary disease [J].
Cramer, Joyce A. ;
Bradley-Kennedy, Carole ;
Scalera, Alissa .
CANADIAN RESPIRATORY JOURNAL, 2007, 14 (01) :25-29
[8]   Efficacy of a new once-daily long-acting inhaled β2-agonist indacaterol versus twice-daily formoterol in COPD [J].
Dahl, Ronald ;
Chung, Kian Fan ;
Buhl, Roland ;
Magnussen, Helgo ;
Nonikov, Vladimir ;
Jack, Damon ;
Bleasdale, Patricia ;
Owen, Roger ;
Higgins, Mark ;
Kramer, Benjamin .
THORAX, 2010, 65 (06) :473-479
[9]  
Donohue James F, 2005, COPD, V2, P111
[10]   Once-Daily Bronchodilators for Chronic Obstructive Pulmonary Disease Indacaterol Versus Tiotropium [J].
Donohue, James F. ;
Fogarty, Charles ;
Lotvall, Jan ;
Mahler, Donald A. ;
Worth, Heinrich ;
Yorgancioglu, Arzu ;
Iqbal, Amir ;
Swales, James ;
Owen, Roger ;
Higgins, Mark ;
Kramer, Benjamin .
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 2010, 182 (02) :155-162