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Roflumilast in Severely Ill Patients with Chronic Obstructive Pulmonary Disease with Frequent Exacerbations: Risk of Pneumonia Hospitalization and Severe Exacerbations

Roflumilast is given as an add-on to inhalation medication in patients with chronic obstructive pulmonary disease (COPD) and chronic bronchitis. Animal experiments have documented deleterious effects of roflumilast in bacterial infections, but trials have not reported the risk of bacterial infection...

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Autores principales: Alispahic, Imane Achir, Sørensen, Rikke, Eklöf, Josefin, Sivapalan, Pradeesh, Løkke, Anders, Seersholm, Niels, Vestergaard, Jakob Hedemark, Jensen, Jens-Ulrik Stæhr
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
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Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7291283/
https://www.ncbi.nlm.nih.gov/pubmed/32408645
http://dx.doi.org/10.3390/jcm9051442
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author Alispahic, Imane Achir
Sørensen, Rikke
Eklöf, Josefin
Sivapalan, Pradeesh
Løkke, Anders
Seersholm, Niels
Vestergaard, Jakob Hedemark
Jensen, Jens-Ulrik Stæhr
author_facet Alispahic, Imane Achir
Sørensen, Rikke
Eklöf, Josefin
Sivapalan, Pradeesh
Løkke, Anders
Seersholm, Niels
Vestergaard, Jakob Hedemark
Jensen, Jens-Ulrik Stæhr
author_sort Alispahic, Imane Achir
collection PubMed
description Roflumilast is given as an add-on to inhalation medication in patients with chronic obstructive pulmonary disease (COPD) and chronic bronchitis. Animal experiments have documented deleterious effects of roflumilast in bacterial infections, but trials have not reported the risk of bacterial infections in patients. The objective of this study is to determine, among outpatients with severe COPD in a two-year follow-up period, the risk of hospitalization-requiring pneumonia, severe acute exacerbation in COPD (AECOPD-hosp), and death. Patients with COPD using roflumilast (roflumilast users) were compared to a propensity score-matched COPD control group not using roflumilast (non-roflumilast users). Roflumilast users had an increased 2-year risk of hospitalization-requiring pneumonia (HR 1.5, 95% CI 1.3 to 1.8, p-value < 0.0001) compared to controls, and of AECOPD-Hosp (hazard ratio(HR) 1.6, 95%, confidence interval (CI) 1.5 to 1.8, p-value < 0.0001) and. When adding an active comparator (theophylline) as a matching variable, the signal was largely unchanged. In conclusion, roflumilast was associated with an increased number of hospitalizations for pneumonia and for AECOPD. Since trials have not reported risks of bacterial complications and data regarding severe exacerbations in roflumilast users are sparse and diverging, these data are concerning. Trials focused on the risk of pneumonia, AECOPD, and other bacterial infections in roflumilast users are needed urgently.
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spelling pubmed-72912832020-06-17 Roflumilast in Severely Ill Patients with Chronic Obstructive Pulmonary Disease with Frequent Exacerbations: Risk of Pneumonia Hospitalization and Severe Exacerbations Alispahic, Imane Achir Sørensen, Rikke Eklöf, Josefin Sivapalan, Pradeesh Løkke, Anders Seersholm, Niels Vestergaard, Jakob Hedemark Jensen, Jens-Ulrik Stæhr J Clin Med Article Roflumilast is given as an add-on to inhalation medication in patients with chronic obstructive pulmonary disease (COPD) and chronic bronchitis. Animal experiments have documented deleterious effects of roflumilast in bacterial infections, but trials have not reported the risk of bacterial infections in patients. The objective of this study is to determine, among outpatients with severe COPD in a two-year follow-up period, the risk of hospitalization-requiring pneumonia, severe acute exacerbation in COPD (AECOPD-hosp), and death. Patients with COPD using roflumilast (roflumilast users) were compared to a propensity score-matched COPD control group not using roflumilast (non-roflumilast users). Roflumilast users had an increased 2-year risk of hospitalization-requiring pneumonia (HR 1.5, 95% CI 1.3 to 1.8, p-value < 0.0001) compared to controls, and of AECOPD-Hosp (hazard ratio(HR) 1.6, 95%, confidence interval (CI) 1.5 to 1.8, p-value < 0.0001) and. When adding an active comparator (theophylline) as a matching variable, the signal was largely unchanged. In conclusion, roflumilast was associated with an increased number of hospitalizations for pneumonia and for AECOPD. Since trials have not reported risks of bacterial complications and data regarding severe exacerbations in roflumilast users are sparse and diverging, these data are concerning. Trials focused on the risk of pneumonia, AECOPD, and other bacterial infections in roflumilast users are needed urgently. MDPI 2020-05-12 /pmc/articles/PMC7291283/ /pubmed/32408645 http://dx.doi.org/10.3390/jcm9051442 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Alispahic, Imane Achir
Sørensen, Rikke
Eklöf, Josefin
Sivapalan, Pradeesh
Løkke, Anders
Seersholm, Niels
Vestergaard, Jakob Hedemark
Jensen, Jens-Ulrik Stæhr
Roflumilast in Severely Ill Patients with Chronic Obstructive Pulmonary Disease with Frequent Exacerbations: Risk of Pneumonia Hospitalization and Severe Exacerbations
title Roflumilast in Severely Ill Patients with Chronic Obstructive Pulmonary Disease with Frequent Exacerbations: Risk of Pneumonia Hospitalization and Severe Exacerbations
title_full Roflumilast in Severely Ill Patients with Chronic Obstructive Pulmonary Disease with Frequent Exacerbations: Risk of Pneumonia Hospitalization and Severe Exacerbations
title_fullStr Roflumilast in Severely Ill Patients with Chronic Obstructive Pulmonary Disease with Frequent Exacerbations: Risk of Pneumonia Hospitalization and Severe Exacerbations
title_full_unstemmed Roflumilast in Severely Ill Patients with Chronic Obstructive Pulmonary Disease with Frequent Exacerbations: Risk of Pneumonia Hospitalization and Severe Exacerbations
title_short Roflumilast in Severely Ill Patients with Chronic Obstructive Pulmonary Disease with Frequent Exacerbations: Risk of Pneumonia Hospitalization and Severe Exacerbations
title_sort roflumilast in severely ill patients with chronic obstructive pulmonary disease with frequent exacerbations: risk of pneumonia hospitalization and severe exacerbations
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7291283/
https://www.ncbi.nlm.nih.gov/pubmed/32408645
http://dx.doi.org/10.3390/jcm9051442
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