Cargando…

Safety of indacaterol in the treatment of patients with COPD

PURPOSE: Pooled data were analyzed to evaluate the safety and tolerability of indacaterol, a once-daily inhaled long-acting β(2)-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-t...

Descripción completa

Detalles Bibliográficos
Autores principales: Donohue, James F, Singh, Dave, Kornmann, Oliver, Lawrence, David, Lassen, Cheryl, Kramer, Benjamin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3186746/
https://www.ncbi.nlm.nih.gov/pubmed/22003293
http://dx.doi.org/10.2147/COPD.S23816
_version_ 1782213294921089024
author Donohue, James F
Singh, Dave
Kornmann, Oliver
Lawrence, David
Lassen, Cheryl
Kramer, Benjamin
author_facet Donohue, James F
Singh, Dave
Kornmann, Oliver
Lawrence, David
Lassen, Cheryl
Kramer, Benjamin
author_sort Donohue, James F
collection PubMed
description PURPOSE: Pooled data were analyzed to evaluate the safety and tolerability of indacaterol, a once-daily inhaled long-acting β(2)-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 β(2)-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.
format Online
Article
Text
id pubmed-3186746
institution National Center for Biotechnology Information
language English
publishDate 2011
publisher Dove Medical Press
record_format MEDLINE/PubMed
spelling pubmed-31867462011-10-14 Safety of indacaterol in the treatment of patients with COPD Donohue, James F Singh, Dave Kornmann, Oliver Lawrence, David Lassen, Cheryl Kramer, Benjamin Int J Chron Obstruct Pulmon Dis Original Research PURPOSE: Pooled data were analyzed to evaluate the safety and tolerability of indacaterol, a once-daily inhaled long-acting β(2)-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 β(2)-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. Dove Medical Press 2011 2011-09-22 /pmc/articles/PMC3186746/ /pubmed/22003293 http://dx.doi.org/10.2147/COPD.S23816 Text en © 2011 Donohue et al, publisher and licensee Dove Medical Press Ltd. This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.
spellingShingle Original Research
Donohue, James F
Singh, Dave
Kornmann, Oliver
Lawrence, David
Lassen, Cheryl
Kramer, Benjamin
Safety of indacaterol in the treatment of patients with COPD
title Safety of indacaterol in the treatment of patients with COPD
title_full Safety of indacaterol in the treatment of patients with COPD
title_fullStr Safety of indacaterol in the treatment of patients with COPD
title_full_unstemmed Safety of indacaterol in the treatment of patients with COPD
title_short Safety of indacaterol in the treatment of patients with COPD
title_sort safety of indacaterol in the treatment of patients with copd
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3186746/
https://www.ncbi.nlm.nih.gov/pubmed/22003293
http://dx.doi.org/10.2147/COPD.S23816
work_keys_str_mv AT donohuejamesf safetyofindacaterolinthetreatmentofpatientswithcopd
AT singhdave safetyofindacaterolinthetreatmentofpatientswithcopd
AT kornmannoliver safetyofindacaterolinthetreatmentofpatientswithcopd
AT lawrencedavid safetyofindacaterolinthetreatmentofpatientswithcopd
AT lassencheryl safetyofindacaterolinthetreatmentofpatientswithcopd
AT kramerbenjamin safetyofindacaterolinthetreatmentofpatientswithcopd