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Safety and efficacy of pirfenidone in severe idiopathic pulmonary fibrosis

Paschalis Ntolios, Andreas Koulelidis, Georgios Zacharis, Argyrios Tzouvelekis, Panagiotis Boglou, Konstantinos Kaltsas, Evangelos Bouros, Theodoros Karampitsakos, Maria Karailidou, Paschalis Steiropoulos, Marios Froudarakis, Demosthenes Bouros
European Respiratory Journal 2014 44: P787; DOI:
Paschalis Ntolios
1Department of Pneumonology, Democritus University of Thrace and University Hospital of Alexandroupolis, Alexandroupolis, Evros, Greece
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Andreas Koulelidis
1Department of Pneumonology, Democritus University of Thrace and University Hospital of Alexandroupolis, Alexandroupolis, Evros, Greece
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Georgios Zacharis
1Department of Pneumonology, Democritus University of Thrace and University Hospital of Alexandroupolis, Alexandroupolis, Evros, Greece
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Argyrios Tzouvelekis
1Department of Pneumonology, Democritus University of Thrace and University Hospital of Alexandroupolis, Alexandroupolis, Evros, Greece
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Panagiotis Boglou
1Department of Pneumonology, Democritus University of Thrace and University Hospital of Alexandroupolis, Alexandroupolis, Evros, Greece
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Konstantinos Kaltsas
1Department of Pneumonology, Democritus University of Thrace and University Hospital of Alexandroupolis, Alexandroupolis, Evros, Greece
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Evangelos Bouros
2Department of Pharmacology, Democritus University of Thrace, Alexandroupolis, Evros, Greece
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Theodoros Karampitsakos
1Department of Pneumonology, Democritus University of Thrace and University Hospital of Alexandroupolis, Alexandroupolis, Evros, Greece
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Maria Karailidou
1Department of Pneumonology, Democritus University of Thrace and University Hospital of Alexandroupolis, Alexandroupolis, Evros, Greece
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Paschalis Steiropoulos
1Department of Pneumonology, Democritus University of Thrace and University Hospital of Alexandroupolis, Alexandroupolis, Evros, Greece
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Marios Froudarakis
1Department of Pneumonology, Democritus University of Thrace and University Hospital of Alexandroupolis, Alexandroupolis, Evros, Greece
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Demosthenes Bouros
1Department of Pneumonology, Democritus University of Thrace and University Hospital of Alexandroupolis, Alexandroupolis, Evros, Greece
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Abstract

Introduction: Pirfenidone is the only, so far, drug approved for the treatment of mild or moderate IPF.

Aim: To study the safety and efficacy of pirfenidone in a group of patients with severe disease (FVC<50% and/or TLco < 35%).

Methods: Pirfenidone was prescribed to 41 patients with severe IPF. Lung function tests, GAP score and 6 minute walk test (6MWT) were recorded prior and 6 months after treatment initiation. Additionally, patients were strictly monitored with blood tests and liver biochemistry, while adverse events (AE) were recorded and compared to data of previous studies.

Results: Mean age was 66.25 ± 12.25. 19.5% were female and 80.5% male. 14.6% had type I respiratory failure. 4.8% had dyspnea MRC I, 22% MRC 2, 39% MRC III, and 34%MRC IV. During the study period 3 patients died from irrelevant to drug causes (1 septic shock, 1 from myocardial infarction and 1 from disease progression) and 7 stopped treatment due to mild-moderate AE. 1 patient stopped for reasons that he did not wish to share. AE included gastro-intestinal discomfort (n=8, 19.5%), photosensitivity (n=5, 12.2%), rash (n=5, 12.2%), fatigue (n=4, 9.75%), diarrhea (n=3, 7.3%), community-acquired pneumonia (n=3, 7.3%), anorexia (n=2, 5%), hematuria (n=2, 4.8%), septic shock (n=2, 4.8%), insomnia, myocardial infarction and irritability one each. No significant differences were observed regarding FVC, TLco, 6MWT, GAP score, SGOT and SGPT pre and 6 months post treatment.

Conclusion: Pirfenidone is safe when administered to patients with severe IPF, since AE were comparable to the AZUMA and CAPACITY trials results. Although patients remained stable, longer treatment periods are needed for definite conclusions regarding efficacy.

  • Idiopathic pulmonary fibrosis
  • Interstitial lung disease
  • Treatments
  • © 2014 ERS
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Safety and efficacy of pirfenidone in severe idiopathic pulmonary fibrosis
Paschalis Ntolios, Andreas Koulelidis, Georgios Zacharis, Argyrios Tzouvelekis, Panagiotis Boglou, Konstantinos Kaltsas, Evangelos Bouros, Theodoros Karampitsakos, Maria Karailidou, Paschalis Steiropoulos, Marios Froudarakis, Demosthenes Bouros
European Respiratory Journal Sep 2014, 44 (Suppl 58) P787;

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Safety and efficacy of pirfenidone in severe idiopathic pulmonary fibrosis
Paschalis Ntolios, Andreas Koulelidis, Georgios Zacharis, Argyrios Tzouvelekis, Panagiotis Boglou, Konstantinos Kaltsas, Evangelos Bouros, Theodoros Karampitsakos, Maria Karailidou, Paschalis Steiropoulos, Marios Froudarakis, Demosthenes Bouros
European Respiratory Journal Sep 2014, 44 (Suppl 58) P787;
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