Document Detail

Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: A 12-week study.
MedLine Citation:
PMID:  21367594     Owner:  NLM     Status:  Publisher    
BACKGROUND: Indacaterol is a novel, inhaled once-daily ultra-long-acting β(2)-agonist for the treatment of COPD. METHODS: This 12-week randomised, parallel-group study compared the efficacy of indacaterol 150 μg once-daily to salmeterol 50 μg 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. NCT00821093.
Stephanie Korn; Edward Kerwin; Sibel Atis; Carolynn Amos; Roger Owen; Cheryl Lassen;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-2-28
Journal Detail:
Title:  Respiratory medicine     Volume:  -     ISSN:  1532-3064     ISO Abbreviation:  -     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-3-3     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8908438     Medline TA:  Respir Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011 Elsevier Ltd. All rights reserved.
Pulmonary Department, Mainz University Hospital, Mainz, Germany.
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