Real-life comparison of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis: A 24-month assessment.


Journal

Respiratory medicine
ISSN: 1532-3064
Titre abrégé: Respir Med
Pays: England
ID NLM: 8908438

Informations de publication

Date de publication:
11 2019
Historique:
received: 18 06 2019
revised: 28 09 2019
accepted: 17 10 2019
pubmed: 2 11 2019
medline: 21 8 2020
entrez: 1 11 2019
Statut: ppublish

Résumé

Real-life data on the use of pirfenidone and nintedanib to treat patients with idiopathic pulmonary fibrosis (IPF) are still scarce. We compared the efficacy of either pirfenidone (n = 78) or nintedanib (n = 28) delivered over a 24-month period in patients with IPF, followed at two regional clinic centers in Italy, with a group of patients who refused the treatment (n = 36), and who were considered to be controls. All patients completed regular visits at 1- to 3-month intervals, where primary [forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO)] and secondary outcomes (side effects, treatment compliance, and mortality) were recorded. Over time, the decline in FVC and DLCO was significantly higher (p = 0.0053 and p = 0.037, respectively) in controls when compared with the combined treated group, with no significant difference between the two treated groups. Compared to patients with less advanced disease (GAP (Gender, Age, Physiology) stage I), those in GAP stages II and III showed a significantly higher decline in both FVC and DLCO irrespective of the drug taken. Side effects were similarly reported in patients receiving pirfenidone and nintedanib (5% and 7%, respectively), whereas mortality did not differ among the three groups. This real-life study demonstrated that both pirfenidone and nintedanib were equally effective in reducing the decline of FVC and DLCO versus non-treated patients after 24 months of treatment; however, patients with more advanced disease were likely to show a more rapid decline in respiratory function.

Sections du résumé

BACKGROUND
Real-life data on the use of pirfenidone and nintedanib to treat patients with idiopathic pulmonary fibrosis (IPF) are still scarce.
METHODS
We compared the efficacy of either pirfenidone (n = 78) or nintedanib (n = 28) delivered over a 24-month period in patients with IPF, followed at two regional clinic centers in Italy, with a group of patients who refused the treatment (n = 36), and who were considered to be controls. All patients completed regular visits at 1- to 3-month intervals, where primary [forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO)] and secondary outcomes (side effects, treatment compliance, and mortality) were recorded.
RESULTS
Over time, the decline in FVC and DLCO was significantly higher (p = 0.0053 and p = 0.037, respectively) in controls when compared with the combined treated group, with no significant difference between the two treated groups. Compared to patients with less advanced disease (GAP (Gender, Age, Physiology) stage I), those in GAP stages II and III showed a significantly higher decline in both FVC and DLCO irrespective of the drug taken. Side effects were similarly reported in patients receiving pirfenidone and nintedanib (5% and 7%, respectively), whereas mortality did not differ among the three groups.
CONCLUSION
This real-life study demonstrated that both pirfenidone and nintedanib were equally effective in reducing the decline of FVC and DLCO versus non-treated patients after 24 months of treatment; however, patients with more advanced disease were likely to show a more rapid decline in respiratory function.

Identifiants

pubmed: 31670147
pii: S0954-6111(19)30310-5
doi: 10.1016/j.rmed.2019.105803
pii:
doi:

Substances chimiques

Indoles 0
Pyridones 0
Carbon Monoxide 7U1EE4V452
pirfenidone D7NLD2JX7U
nintedanib G6HRD2P839

Types de publication

Comparative Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

105803

Informations de copyright

Copyright © 2019 Elsevier Ltd. All rights reserved.

Auteurs

Stefania Cerri (S)

Pneumology Unit, University Hospital of Modena Policlinico, Modena, Italy.

Matteo Monari (M)

Alma Mater University, Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy.

Aldo Guerrieri (A)

Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy.

Pierluigi Donatelli (P)

Department of Medical and Surgical Sciences and Post-doctoral School of Respiratory Diseases, University of Modena Reggio Emilia, Modena, Italy.

Ilaria Bassi (I)

Alma Mater University, Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy.

Martina Garuti (M)

Department of Medical and Surgical Sciences and Post-doctoral School of Respiratory Diseases, University of Modena Reggio Emilia, Modena, Italy.

Fabrizio Luppi (F)

Cardio-Thoracic-Vascular Department, University of Milano Bicocca and Respiratory Unit, San Gerardo Hospital, Monza, Italy.

Sara Betti (S)

Alma Mater University, Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy.

Gianpiero Bandelli (G)

Alma Mater University, Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy.

Marco Carpano (M)

Alma Mater University, Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy.

Maria Letizia Bacchi Reggiani (ML)

Alma Mater University, Department of Clinical, Integrated and Experimental Medicine (DIMES), Statistical Service, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy.

Roberto Tonelli (R)

Department of Medical and Surgical Sciences and Post-doctoral School of Respiratory Diseases, University of Modena Reggio Emilia, Modena, Italy; Clinical and Experimental Medicine PhD Program, University of Modena Reggio Emilia, Modena, Italy.

Enrico Clini (E)

Pneumology Unit, University Hospital of Modena Policlinico, Modena, Italy; Alma Mater University, Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy; Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy; Department of Medical and Surgical Sciences and Post-doctoral School of Respiratory Diseases, University of Modena Reggio Emilia, Modena, Italy.

Stefano Nava (S)

Alma Mater University, Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy. Electronic address: stefanava@gmail.com.

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