Pirfenidone in idiopathic pulmonary fibrosis

H. Taniguchi; M. Ebina; Y. Kondoh; T. Ogura; A. Azuma; M. Suga; Y. Taguchie; H. Takahashi; K. Nakata; A. Sato; M. Takeuchi; G. Raghu; S. Kudoh; T. Nukiwa; T. Betsuyaku; Y. Sugawara; S. Fujiuchi; K. Yamauchi; K. Konishi; M. Munakata; Y. Kimura; Y. Ishii; Y. Sugiyama; K. Kudoh; T. Saito; T. Yamaguchi; A. Mizoo; A. Nagai; A. Ishizaka; K. Yamaguchi; K. Yoshimura; M. Oritsu; Y. Fukuchi; K. Takahashi; K. Kimura; Y. Yoshizawa; T. Nagase; T. Hisada; K. Ohta; K. Yoshimori; Y. Miyazawa; K. Tatsumi; Y. Sasaki; M. Taniguchi; Y. Sugita; E. Suzuki; Y. Saito; H. Nakamura; K. Chida; N. Kasamatsu; H. Hayakawa; K. Yasuda; H. Suganuma; H. Genma; R. Tamura; T. Shirai; J. Shindoh; S. Sato; O. Taguchi; Y. Sasaki; H. Ibata; M. Yasui; Y. Nakano; M. Ito; S. Kitada; H. Kimura; Y. Inoue; H. Yasuba; Y. Mochizuki; S. Horikawa; Y. Suzuki; N. Katakami; Y. Tanimoto; Y. Hitsuda; N. Burioka; T. Sato; N. Kohno; A. Yokoyama; Y. Nishioka; N. Ueda; K. Kuwano; K. Watanabe; H. Aizawa; S. Kohno; H. Mukae; H. Kohrogi; J. Kadota; I. Tokimatsu; E. Miyazaki; T. Sasaki; M. Kawabata

doi:10.1183/09031936.00005209

Pirfenidone in idiopathic pulmonary fibrosis

H. Taniguchi, M. Ebina, Y. Kondoh, T. Ogura, A. Azuma, M. Suga, Y. Taguchie, H. Takahashi, K. Nakata, A. Sato, M. Takeuchi, G. Raghu, S. Kudoh, T. Nukiwa, T. Betsuyaku, Y. Sugawara, S. Fujiuchi, K. Yamauchi, K. Konishi, M. MunakataY. Kimura, Y. Ishii, Y. Sugiyama, K. Kudoh, T. Saito, T. Yamaguchi, A. Mizoo, A. Nagai, A. Ishizaka, K. Yamaguchi, K. Yoshimura, M. Oritsu, Y. Fukuchi, K. Takahashi, K. Kimura, Y. Yoshizawa, T. Nagase, T. Hisada, K. Ohta, K. Yoshimori, Y. Miyazawa, K. Tatsumi, Y. Sasaki, M. Taniguchi, Y. Sugita, E. Suzuki, Y. Saito, H. Nakamura, K. Chida, N. Kasamatsu, H. Hayakawa, K. Yasuda, H. Suganuma, H. Genma, R. Tamura, T. Shirai, J. Shindoh, S. Sato, O. Taguchi, Y. Sasaki, H. Ibata, M. Yasui, Y. Nakano, M. Ito, S. Kitada, H. Kimura, Y. Inoue, H. Yasuba, Y. Mochizuki, S. Horikawa, Y. Suzuki, N. Katakami, Y. Tanimoto, Y. Hitsuda, N. Burioka, T. Sato, N. Kohno, A. Yokoyama, Y. Nishioka, N. Ueda, K. Kuwano, K. Watanabe, H. Aizawa, S. Kohno, H. Mukae, H. Kohrogi, J. Kadota, I. Tokimatsu, E. Miyazaki, T. Sasaki, M. Kawabata

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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) (p50.0416); differences between the two groups (p50.0280) 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. Copyright

Original language	English
Pages (from-to)	821-829
Number of pages	9
Journal	European Respiratory Journal
Volume	35
Issue number	4
DOIs	https://doi.org/10.1183/09031936.00005209
Publication status	Published - 2010 Apr
Externally published	Yes

Keywords

Idiopathic pulmonary fibrosis
Pirfenidone
Progression-free survival time
Vital capacity

ASJC Scopus subject areas

Pulmonary and Respiratory Medicine

Access to Document

10.1183/09031936.00005209

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Taniguchi, H., Ebina, M., Kondoh, Y., Ogura, T., Azuma, A., Suga, M., Taguchie, Y., Takahashi, H., Nakata, K., Sato, A., Takeuchi, M., Raghu, G., Kudoh, S., Nukiwa, T., Betsuyaku, T., Sugawara, Y., Fujiuchi, S., Yamauchi, K., Konishi, K., ... Kawabata, M. (2010). Pirfenidone in idiopathic pulmonary fibrosis. European Respiratory Journal, 35(4), 821-829. https://doi.org/10.1183/09031936.00005209

Taniguchi, H, Ebina, M, Kondoh, Y, Ogura, T, Azuma, A, Suga, M, Taguchie, Y, Takahashi, H, Nakata, K, Sato, A, Takeuchi, M, Raghu, G, Kudoh, S, Nukiwa, T, Betsuyaku, T, Sugawara, Y, Fujiuchi, S, Yamauchi, K, Konishi, K, Munakata, M, Kimura, Y, Ishii, Y, Sugiyama, Y, Kudoh, K, Saito, T, Yamaguchi, T, Mizoo, A, Nagai, A, Ishizaka, A, Yamaguchi, K, Yoshimura, K, Oritsu, M, Fukuchi, Y, Takahashi, K, Kimura, K, Yoshizawa, Y, Nagase, T, Hisada, T, Ohta, K, Yoshimori, K, Miyazawa, Y, Tatsumi, K, Sasaki, Y, Taniguchi, M, Sugita, Y, Suzuki, E, Saito, Y, Nakamura, H, Chida, K, Kasamatsu, N, Hayakawa, H, Yasuda, K, Suganuma, H, Genma, H, Tamura, R, Shirai, T, Shindoh, J, Sato, S, Taguchi, O, Sasaki, Y, Ibata, H, Yasui, M, Nakano, Y, Ito, M, Kitada, S, Kimura, H, Inoue, Y, Yasuba, H, Mochizuki, Y, Horikawa, S, Suzuki, Y, Katakami, N, Tanimoto, Y, Hitsuda, Y, Burioka, N, Sato, T, Kohno, N, Yokoyama, A, Nishioka, Y, Ueda, N, Kuwano, K, Watanabe, K, Aizawa, H, Kohno, S, Mukae, H, Kohrogi, H, Kadota, J, Tokimatsu, I, Miyazaki, E, Sasaki, T & Kawabata, M 2010, 'Pirfenidone in idiopathic pulmonary fibrosis', European Respiratory Journal, vol. 35, no. 4, pp. 821-829. https://doi.org/10.1183/09031936.00005209

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title = "Pirfenidone in idiopathic pulmonary fibrosis",

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) (p50.0416); differences between the two groups (p50.0280) 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. Copyright",

keywords = "Idiopathic pulmonary fibrosis, Pirfenidone, Progression-free survival time, Vital capacity",

author = "H. Taniguchi and M. Ebina and Y. Kondoh and T. Ogura and A. Azuma and M. Suga and Y. Taguchie and H. Takahashi and K. Nakata and A. Sato and M. Takeuchi and G. Raghu and S. Kudoh and T. Nukiwa and T. Betsuyaku and Y. Sugawara and S. Fujiuchi and K. Yamauchi and K. Konishi and M. Munakata and Y. Kimura and Y. Ishii and Y. Sugiyama and K. Kudoh and T. Saito and T. Yamaguchi and A. Mizoo and A. Nagai and A. Ishizaka and K. Yamaguchi and K. Yoshimura and M. Oritsu and Y. Fukuchi and K. Takahashi and K. Kimura and Y. Yoshizawa and T. Nagase and T. Hisada and K. Ohta and K. Yoshimori and Y. Miyazawa and K. Tatsumi and Y. Sasaki and M. Taniguchi and Y. Sugita and E. Suzuki and Y. Saito and H. Nakamura and K. Chida and N. Kasamatsu and H. Hayakawa and K. Yasuda and H. Suganuma and H. Genma and R. Tamura and T. Shirai and J. Shindoh and S. Sato and O. Taguchi and Y. Sasaki and H. Ibata and M. Yasui and Y. Nakano and M. Ito and S. Kitada and H. Kimura and Y. Inoue and H. Yasuba and Y. Mochizuki and S. Horikawa and Y. Suzuki and N. Katakami and Y. Tanimoto and Y. Hitsuda and N. Burioka and T. Sato and N. Kohno and A. Yokoyama and Y. Nishioka and N. Ueda and K. Kuwano and K. Watanabe and H. Aizawa and S. Kohno and H. Mukae and H. Kohrogi and J. Kadota and I. Tokimatsu and E. Miyazaki and T. Sasaki and M. Kawabata",

year = "2010",

month = apr,

doi = "10.1183/09031936.00005209",

language = "English",

volume = "35",

pages = "821--829",

journal = "Scandinavian Journal of Respiratory Diseases",

issn = "0903-1936",

publisher = "European Respiratory Society",

number = "4",

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TY - JOUR

T1 - Pirfenidone in idiopathic pulmonary fibrosis

AU - Taniguchi, H.

AU - Ebina, M.

AU - Kondoh, Y.

AU - Ogura, T.

AU - Azuma, A.

AU - Suga, M.

AU - Taguchie, Y.

AU - Takahashi, H.

AU - Nakata, K.

AU - Sato, A.

AU - Takeuchi, M.

AU - Raghu, G.

AU - Kudoh, S.

AU - Nukiwa, T.

AU - Betsuyaku, T.

AU - Sugawara, Y.

AU - Fujiuchi, S.

AU - Yamauchi, K.

AU - Konishi, K.

AU - Munakata, M.

AU - Kimura, Y.

AU - Ishii, Y.

AU - Sugiyama, Y.

AU - Kudoh, K.

AU - Saito, T.

AU - Yamaguchi, T.

AU - Mizoo, A.

AU - Nagai, A.

AU - Ishizaka, A.

AU - Yamaguchi, K.

AU - Yoshimura, K.

AU - Oritsu, M.

AU - Fukuchi, Y.

AU - Takahashi, K.

AU - Kimura, K.

AU - Yoshizawa, Y.

AU - Nagase, T.

AU - Hisada, T.

AU - Ohta, K.

AU - Yoshimori, K.

AU - Miyazawa, Y.

AU - Tatsumi, K.

AU - Sasaki, Y.

AU - Taniguchi, M.

AU - Sugita, Y.

AU - Suzuki, E.

AU - Saito, Y.

AU - Nakamura, H.

AU - Chida, K.

AU - Kasamatsu, N.

AU - Hayakawa, H.

AU - Yasuda, K.

AU - Suganuma, H.

AU - Genma, H.

AU - Tamura, R.

AU - Shirai, T.

AU - Shindoh, J.

AU - Sato, S.

AU - Taguchi, O.

AU - Sasaki, Y.

AU - Ibata, H.

AU - Yasui, M.

AU - Nakano, Y.

AU - Ito, M.

AU - Kitada, S.

AU - Kimura, H.

AU - Inoue, Y.

AU - Yasuba, H.

AU - Mochizuki, Y.

AU - Horikawa, S.

AU - Suzuki, Y.

AU - Katakami, N.

AU - Tanimoto, Y.

AU - Hitsuda, Y.

AU - Burioka, N.

AU - Sato, T.

AU - Kohno, N.

AU - Yokoyama, A.

AU - Nishioka, Y.

AU - Ueda, N.

AU - Kuwano, K.

AU - Watanabe, K.

AU - Aizawa, H.

AU - Kohno, S.

AU - Mukae, H.

AU - Kohrogi, H.

AU - Kadota, J.

AU - Tokimatsu, I.

AU - Miyazaki, E.

AU - Sasaki, T.

AU - Kawabata, M.

PY - 2010/4

Y1 - 2010/4

N2 - 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) (p50.0416); differences between the two groups (p50.0280) 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. Copyright

AB - 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) (p50.0416); differences between the two groups (p50.0280) 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. Copyright

KW - Idiopathic pulmonary fibrosis

KW - Pirfenidone

KW - Progression-free survival time

KW - Vital capacity

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EP - 829

JO - Scandinavian Journal of Respiratory Diseases

JF - Scandinavian Journal of Respiratory Diseases

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ER -

Pirfenidone in idiopathic pulmonary fibrosis

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