Back to Journals » International Journal of Chronic Obstructive Pulmonary Disease » Volume 6

Safety of indacaterol in the treatment of patients with COPD

Authors Donohue JF, Singh D, Kornmann O, Lawrence D, Lassen C, Kramer B

Published 22 September 2011 Volume 2011:6 Pages 477—492

DOI https://doi.org/10.2147/COPD.S23816

Review by Single-blind

Peer reviewer comments 4

James F Donohue1, Dave Singh2, Oliver Kornmann3, David Lawrence4, Cheryl Lassen4, Benjamin Kramer5
1University of North Carolina, Chapel Hill, NC, USA; 2University of Manchester, Medicines Evaluation Unit, Manchester, UK; 3IKF Pneumologie GmbH and Co KG, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany; 4Novartis Horsham Research Centre, Horsham, UK; 5Novartis Pharmaceuticals Inc, East Hanover, New Jersey, USA

Purpose: Pooled data were analyzed to evaluate the safety and tolerability of indacaterol, a once-daily inhaled long-acting ß2-agonist for chronic obstructive pulmonary disease (COPD).
Patients and methods: Data were pooled from clinical studies of 3–12 months’ duration in patients with moderate-to-severe COPD receiving double-blind indacaterol 75 µg (n = 449), 150 µg (n = 2611), 300 µg (n = 1157), or 600 µg once daily (n = 547); formoterol 12 µg twice daily (n = 556); salmeterol 50 µg twice daily (n = 895); placebo (n = 2012); or tiotropium 18 µg once daily, given open label or blinded (n = 1214). Outcomes were adverse events, serious adverse events and deaths, plasma potassium, blood glucose, and QTc interval and vital signs.
Results: The commonest adverse events with indacaterol were COPD worsening, nasopharyngitis, and headache; most cases were mild or moderate and incidence was generally similar to placebo and other active treatments. The risk of acute respiratory serious adverse events (leading to hospitalization, intubation, or death) was not significantly increased with any of the active treatments compared with placebo. COPD exacerbation rates (analyzed in the intent-to-treat population) were significantly reduced with all active treatments versus placebo. Hazard ratios versus placebo for major cardiovascular adverse events were <1 for all indacaterol doses. Notable values for vital signs and measures of systemic ß2-adrenoceptor activity were rare with indacaterol. The number of deaths adjusted per patient-year was lower with indacaterol (all doses combined) than with placebo (relative risk 0.21 [95% confidence interval 0.07–0.660], P = 0.008).
Conclusion: Indacaterol has a good profile of safety and tolerability that is appropriate for the maintenance treatment of patients with COPD.

Keywords: indacaterol, safety, tolerability, formoterol, salmeterol, tiotropium

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]

 

Readers of this article also read:

P-wave indices in patients with pulmonary emphysema: do P-terminal force and interatrial block have confounding effects?

Chhabra L, Chaubey VK, Kothagundla C, Bajaj R, Kaul S, Spodick DH

International Journal of Chronic Obstructive Pulmonary Disease 2013, 8:245-250

Published Date: 14 May 2013

Outcome of pulmonary rehabilitation in COPD patients with severely impaired health status

van Ranst D, Otten H, Meijer JW, van 't Hul AJ

International Journal of Chronic Obstructive Pulmonary Disease 2011, 6:647-657

Published Date: 1 December 2011

Long-term azithromycin therapy in patients with severe COPD and repeated exacerbations

Pomares X, Montón C, Espasa M, Casabon J, Monsó E, Gallego M

International Journal of Chronic Obstructive Pulmonary Disease 2011, 6:449-456

Published Date: 6 September 2011

Delivery characteristics and patients’ handling of two single-dose dry-powder inhalers used in COPD

Chapman KR, Fogarty CM, Peckitt C, Lassen C, Jadayel D, Dederichs J, Dalvi M, Kramer B

International Journal of Chronic Obstructive Pulmonary Disease 2011, 6:353-363

Published Date: 23 June 2011

Optimizing management of chronic obstructive pulmonary disease in the upcoming decade

Richard Russell, Antonio Anzueto, Idelle Weisman

International Journal of Chronic Obstructive Pulmonary Disease 2011, 6:47-61

Published Date: 10 January 2011