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Pirfenidone in idiopathic pulmonary fibrosis

Open access
Taniguchi, H., Ebina, M., Kondoh, Y., Ogura, T., Azuma, A., Suga, M., Taguchi, Y., Takahashi, H., Nakata, K., Sato, A., Takeuchi, M., Raghu, G., Kudoh, S., Nukiwa, T., the Pirfenidone Clinical Study Group in Japan·2010·European Respiratory Journal

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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Metadata

Authors
Taniguchi, H., Ebina, M., Kondoh, Y., Ogura, T., Azuma, A., Suga, M., Taguchi, Y., Takahashi, H., Nakata, K., Sato, A., Takeuchi, M., Raghu, G., Kudoh, S., Nukiwa, T., & the Pirfenidone Clinical Study Group in Japan
Venue
European Respiratory Journal
Published
2009-12-08
Volume
35
Issue
4
Pages
821-829
ISSN
  • 0903-1936 (ISSN-L)
  • 1399-3003
OpenAlex
W4296612182
Cited by
946
References
5
FWCI
33.54
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Pirfenidone in idiopathic pulmonary fibrosis. https://app.cochat.ai/papers/10.1183/09031936.00005209
The paper
Taniguchi, H., Ebina, M., Kondoh, Y., Ogura, T., Azuma, A., Suga, M., Taguchi, Y., Takahashi, H., Nakata, K., Sato, A., Takeuchi, M., Raghu, G., Kudoh, S., Nukiwa, T., & the Pirfenidone Clinical Study Group in Japan. (2010). Pirfenidone in idiopathic pulmonary fibrosis. European Respiratory Journal. https://doi.org/10.1183/09031936.00005209

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.