Pirfenidone in idiopathic pulmonary fibrosis
Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease without proven effective therapy. A multicentre, double-blind, placebo-controlled, randomised phase III clinical trial was conducted in Japanese patients with well-defined IPF to determine the efficacy and safety of pirfenidone, a nov...
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| Published in | The European respiratory journal Vol. 35; no. 4; pp. 821 - 829 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Leeds
Eur Respiratory Soc
01.04.2010
Maney |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0903-1936 1399-3003 1399-3003 |
| DOI | 10.1183/09031936.00005209 |
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| Abstract | Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease without proven effective therapy.
A multicentre, double-blind, placebo-controlled, randomised phase III clinical trial was conducted in Japanese patients with well-defined IPF to determine the efficacy and safety of pirfenidone, a novel antifibrotic oral agent, over 52 weeks. Of 275 patients randomised (high-dose, 1,800 mg·day −1 ; low-dose, 1,200 mg·day −1 ; or placebo groups in the ratio 2:1:2), 267 patients were evaluated for the efficacy of pirfenidone. Prior to unblinding, the primary end-point was revised; the change in vital capacity (VC) was assessed at week 52. Secondary end-points included the progression-free survival (PFS) time.
Significant differences were observed in VC decline (primary end-point) between the placebo group (-0.16 L) and the high-dose group (-0.09 L) (p = 0.0416); differences between the two groups (p = 0.0280) were also observed in the PFS (the secondary end-point). Although photosensitivity, a well-established side-effect of pirfenidone, was the major adverse event in this study, it was mild in severity in most of the patients.
Pirfenidone was relatively well tolerated in patients with IPF. Treatment with pirfenidone may decrease the rate of decline in VC and may increase the PFS time over 52 weeks. Additional studies are needed to confirm these findings. |
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| AbstractList | Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease without proven effective therapy.
A multicentre, double-blind, placebo-controlled, randomised phase III clinical trial was conducted in Japanese patients with well-defined IPF to determine the efficacy and safety of pirfenidone, a novel antifibrotic oral agent, over 52 weeks. Of 275 patients randomised (high-dose, 1,800 mg·day −1 ; low-dose, 1,200 mg·day −1 ; or placebo groups in the ratio 2:1:2), 267 patients were evaluated for the efficacy of pirfenidone. Prior to unblinding, the primary end-point was revised; the change in vital capacity (VC) was assessed at week 52. Secondary end-points included the progression-free survival (PFS) time.
Significant differences were observed in VC decline (primary end-point) between the placebo group (-0.16 L) and the high-dose group (-0.09 L) (p = 0.0416); differences between the two groups (p = 0.0280) were also observed in the PFS (the secondary end-point). Although photosensitivity, a well-established side-effect of pirfenidone, was the major adverse event in this study, it was mild in severity in most of the patients.
Pirfenidone was relatively well tolerated in patients with IPF. Treatment with pirfenidone may decrease the rate of decline in VC and may increase the PFS time over 52 weeks. Additional studies are needed to confirm these findings. Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease without proven effective therapy. A multicentre, double-blind, placebo-controlled, randomised phase III clinical trial was conducted in Japanese patients with well-defined IPF to determine the efficacy and safety of pirfenidone, a novel antifibrotic oral agent, over 52 weeks. Of 275 patients randomised (high-dose, 1,800 mg x day(-1); low-dose, 1,200 mg x day(-1); or placebo groups in the ratio 2:1:2), 267 patients were evaluated for the efficacy of pirfenidone. Prior to unblinding, the primary end-point was revised; the change in vital capacity (VC) was assessed at week 52. Secondary end-points included the progression-free survival (PFS) time. Significant differences were observed in VC decline (primary end-point) between the placebo group (-0.16 L) and the high-dose group (-0.09 L) (p = 0.0416); differences between the two groups (p = 0.0280) were also observed in the PFS (the secondary end-point). Although photosensitivity, a well-established side-effect of pirfenidone, was the major adverse event in this study, it was mild in severity in most of the patients. Pirfenidone was relatively well tolerated in patients with IPF. Treatment with pirfenidone may decrease the rate of decline in VC and may increase the PFS time over 52 weeks. Additional studies are needed to confirm these findings.Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease without proven effective therapy. A multicentre, double-blind, placebo-controlled, randomised phase III clinical trial was conducted in Japanese patients with well-defined IPF to determine the efficacy and safety of pirfenidone, a novel antifibrotic oral agent, over 52 weeks. Of 275 patients randomised (high-dose, 1,800 mg x day(-1); low-dose, 1,200 mg x day(-1); or placebo groups in the ratio 2:1:2), 267 patients were evaluated for the efficacy of pirfenidone. Prior to unblinding, the primary end-point was revised; the change in vital capacity (VC) was assessed at week 52. Secondary end-points included the progression-free survival (PFS) time. Significant differences were observed in VC decline (primary end-point) between the placebo group (-0.16 L) and the high-dose group (-0.09 L) (p = 0.0416); differences between the two groups (p = 0.0280) were also observed in the PFS (the secondary end-point). Although photosensitivity, a well-established side-effect of pirfenidone, was the major adverse event in this study, it was mild in severity in most of the patients. Pirfenidone was relatively well tolerated in patients with IPF. Treatment with pirfenidone may decrease the rate of decline in VC and may increase the PFS time over 52 weeks. Additional studies are needed to confirm these findings. Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease without proven effective therapy. A multicentre, double-blind, placebo-controlled, randomised phase III clinical trial was conducted in Japanese patients with well-defined IPF to determine the efficacy and safety of pirfenidone, a novel antifibrotic oral agent, over 52 weeks. Of 275 patients randomised (high-dose, 1,800 mg x day(-1); low-dose, 1,200 mg x day(-1); or placebo groups in the ratio 2:1:2), 267 patients were evaluated for the efficacy of pirfenidone. Prior to unblinding, the primary end-point was revised; the change in vital capacity (VC) was assessed at week 52. Secondary end-points included the progression-free survival (PFS) time. Significant differences were observed in VC decline (primary end-point) between the placebo group (-0.16 L) and the high-dose group (-0.09 L) (p = 0.0416); differences between the two groups (p = 0.0280) were also observed in the PFS (the secondary end-point). Although photosensitivity, a well-established side-effect of pirfenidone, was the major adverse event in this study, it was mild in severity in most of the patients. Pirfenidone was relatively well tolerated in patients with IPF. Treatment with pirfenidone may decrease the rate of decline in VC and may increase the PFS time over 52 weeks. Additional studies are needed to confirm these findings. |
| Author | Ebina, M Takeuchi, M Raghu, G Azuma, A Sato, A Ogura, T Takahashi, H Kudoh, S Taguchi, Y Pirfenidone Clinical Study Group in Japan Nukiwa, T Suga, M Taniguchi, H Nakata, K Kondoh, Y |
| Author_xml | – sequence: 1 fullname: Taniguchi, H – sequence: 2 fullname: Ebina, M – sequence: 3 fullname: Kondoh, Y – sequence: 4 fullname: Ogura, T – sequence: 5 fullname: Azuma, A – sequence: 6 fullname: Suga, M – sequence: 7 fullname: Taguchi, Y – sequence: 8 fullname: Takahashi, H – sequence: 9 fullname: Nakata, K – sequence: 10 fullname: Sato, A – sequence: 11 fullname: Takeuchi, M – sequence: 12 fullname: Raghu, G – sequence: 13 fullname: Kudoh, S – sequence: 14 fullname: Nukiwa, T – sequence: 15 fullname: Pirfenidone Clinical Study Group in Japan |
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| Keywords | Lung disease progression-free survival time Pulmonary fibrosis Prognosis Respiratory disease Idiopathic pulmonary fibrosis Idiopathic Vital capacity Pirfenidone Survival Pneumology |
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| References | 2024102020083675000_35.4.821.27 2024102020083675000_35.4.821.26 2024102020083675000_35.4.821.25 2024102020083675000_35.4.821.24 2024102020083675000_35.4.821.23 (2024102020083675000_35.4.821.10) 1999; 291 2024102020083675000_35.4.821.22 2024102020083675000_35.4.821.21 2024102020083675000_35.4.821.20 (2024102020083675000_35.4.821.12) 1999; 289 (2024102020083675000_35.4.821.9) 2002; 41 2024102020083675000_35.4.821.4 2024102020083675000_35.4.821.5 2024102020083675000_35.4.821.2 2024102020083675000_35.4.821.3 2024102020083675000_35.4.821.8 2024102020083675000_35.4.821.6 2024102020083675000_35.4.821.7 (2024102020083675000_35.4.821.11) 1999; 276 2024102020083675000_35.4.821.1 2024102020083675000_35.4.821.29 2024102020083675000_35.4.821.28 2024102020083675000_35.4.821.16 2024102020083675000_35.4.821.15 2024102020083675000_35.4.821.14 2024102020083675000_35.4.821.13 2024102020083675000_35.4.821.30 (2024102020083675000_35.4.821.18) 1974; 15 2024102020083675000_35.4.821.19 2024102020083675000_35.4.821.17 21844516 - Am J Respir Crit Care Med. 2011 Aug 15;184(4):482-3 20930209 - Eur Respir J. 2010 Sep;36(3):695-6; author reply 696-8 20356985 - Eur Respir J. 2010 Apr;35(4):728-9 |
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| Snippet | Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease without proven effective therapy.
A multicentre, double-blind, placebo-controlled, randomised... Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease without proven effective therapy. A multicentre, double-blind, placebo-controlled, randomised... |
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| SubjectTerms | Adult Aged Anti-Inflammatory Agents, Non-Steroidal - administration & dosage Anti-Inflammatory Agents, Non-Steroidal - adverse effects Biological and medical sciences Disease-Free Survival Female Humans Idiopathic Pulmonary Fibrosis - drug therapy Male Medical sciences Middle Aged Oximetry Patient Compliance Placebo Effect Pneumology Pyridones - administration & dosage Pyridones - adverse effects Respiratory system : syndromes and miscellaneous diseases Treatment Outcome Vital Capacity - drug effects Young Adult |
| Title | Pirfenidone in idiopathic pulmonary fibrosis |
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