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Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience

Pirfenidone and nintedanib are the only two drugs approved for the treatment of idiopathic pulmonary fibrosis (IPF). Both proved to be safe and well-tolerated in clinical trials, but real-world data and direct comparisons are scarce. This real-life study explored the safety profile of pirfenidone an...

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Autores principales: Levra, Stefano, Guida, Giuseppe, Sprio, Andrea Elio, Crosa, Flavio, Ghio, Paolo Carlo, Bertolini, Francesca, Carriero, Vitina, Albera, Carlo, Ricciardolo, Fabio Luigi Massimo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9775369/
https://www.ncbi.nlm.nih.gov/pubmed/36551989
http://dx.doi.org/10.3390/biomedicines10123229
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author Levra, Stefano
Guida, Giuseppe
Sprio, Andrea Elio
Crosa, Flavio
Ghio, Paolo Carlo
Bertolini, Francesca
Carriero, Vitina
Albera, Carlo
Ricciardolo, Fabio Luigi Massimo
author_facet Levra, Stefano
Guida, Giuseppe
Sprio, Andrea Elio
Crosa, Flavio
Ghio, Paolo Carlo
Bertolini, Francesca
Carriero, Vitina
Albera, Carlo
Ricciardolo, Fabio Luigi Massimo
author_sort Levra, Stefano
collection PubMed
description Pirfenidone and nintedanib are the only two drugs approved for the treatment of idiopathic pulmonary fibrosis (IPF). Both proved to be safe and well-tolerated in clinical trials, but real-world data and direct comparisons are scarce. This real-life study explored the safety profile of pirfenidone and nintedanib with a prolonged follow-up. We retrospectively collected clinical status, adverse events (AEs), and treatment changes from IPF patients who had started an antifibrotic treatment at our centre from December 2011 to December 2020, including 192 patients treated with pirfenidone and 89 with nintedanib. The majority of patients in both groups experienced one or more AEs during the follow-up. A higher proportion of AEs in the nintedanib group were effectively treated with behavioural modifications or additional medications compared with the pirfenidone group (52.5% vs. 40.6%, p = 0.04). Overall, a difference in the impact of AEs due to nintedanib versus pirfenidone resulted in a lower permanent discontinuation of therapy (8.3% vs. 18.3%, p = 0.02), with the latter being associated with a higher risk of drug discontinuation at 48 months after initiation (OR = 2.52, p = 0.03). Our study confirms the safety profile of antifibrotic drugs in IPF but highlights that AEs due to nintedanib are usually easier to manage and lead to fewer cases of permanent discontinuation of therapy.
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spelling pubmed-97753692022-12-23 Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience Levra, Stefano Guida, Giuseppe Sprio, Andrea Elio Crosa, Flavio Ghio, Paolo Carlo Bertolini, Francesca Carriero, Vitina Albera, Carlo Ricciardolo, Fabio Luigi Massimo Biomedicines Article Pirfenidone and nintedanib are the only two drugs approved for the treatment of idiopathic pulmonary fibrosis (IPF). Both proved to be safe and well-tolerated in clinical trials, but real-world data and direct comparisons are scarce. This real-life study explored the safety profile of pirfenidone and nintedanib with a prolonged follow-up. We retrospectively collected clinical status, adverse events (AEs), and treatment changes from IPF patients who had started an antifibrotic treatment at our centre from December 2011 to December 2020, including 192 patients treated with pirfenidone and 89 with nintedanib. The majority of patients in both groups experienced one or more AEs during the follow-up. A higher proportion of AEs in the nintedanib group were effectively treated with behavioural modifications or additional medications compared with the pirfenidone group (52.5% vs. 40.6%, p = 0.04). Overall, a difference in the impact of AEs due to nintedanib versus pirfenidone resulted in a lower permanent discontinuation of therapy (8.3% vs. 18.3%, p = 0.02), with the latter being associated with a higher risk of drug discontinuation at 48 months after initiation (OR = 2.52, p = 0.03). Our study confirms the safety profile of antifibrotic drugs in IPF but highlights that AEs due to nintedanib are usually easier to manage and lead to fewer cases of permanent discontinuation of therapy. MDPI 2022-12-12 /pmc/articles/PMC9775369/ /pubmed/36551989 http://dx.doi.org/10.3390/biomedicines10123229 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/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 (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Levra, Stefano
Guida, Giuseppe
Sprio, Andrea Elio
Crosa, Flavio
Ghio, Paolo Carlo
Bertolini, Francesca
Carriero, Vitina
Albera, Carlo
Ricciardolo, Fabio Luigi Massimo
Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience
title Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience
title_full Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience
title_fullStr Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience
title_full_unstemmed Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience
title_short Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience
title_sort long-term safety of antifibrotic drugs in ipf: a real-world experience
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9775369/
https://www.ncbi.nlm.nih.gov/pubmed/36551989
http://dx.doi.org/10.3390/biomedicines10123229
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