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, Tomoko Betsuyaku, Y. Sugawara, S. Fujiuchi, K. Yamauchi, K. Konishi, M. Munakata & 71 others 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

Research output: Contribution to journalArticle

598 Citations (Scopus)

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 languageEnglish
Pages (from-to)821-829
Number of pages9
JournalEuropean Respiratory Journal
Volume35
Issue number4
DOIs
Publication statusPublished - 2010 Apr
Externally publishedYes

Fingerprint

Idiopathic Pulmonary Fibrosis
Vital Capacity
Disease-Free Survival
Placebos
Phase III Clinical Trials
Lung Diseases
Randomized Controlled Trials
pirfenidone
Safety
Therapeutics

Keywords

  • Idiopathic pulmonary fibrosis
  • Pirfenidone
  • Progression-free survival time
  • Vital capacity

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Taniguchi, H., Ebina, M., Kondoh, Y., Ogura, T., Azuma, A., Suga, M., ... Kawabata, M. (2010). Pirfenidone in idiopathic pulmonary fibrosis. European Respiratory Journal, 35(4), 821-829. https://doi.org/10.1183/09031936.00005209

Pirfenidone in idiopathic pulmonary fibrosis. / 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, Tomoko; 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.

In: European Respiratory Journal, Vol. 35, No. 4, 04.2010, p. 821-829.

Research output: Contribution to journalArticle

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
Taniguchi H, Ebina M, Kondoh Y, Ogura T, Azuma A, Suga M et al. Pirfenidone in idiopathic pulmonary fibrosis. European Respiratory Journal. 2010 Apr;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, Tomoko ; 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. / Pirfenidone in idiopathic pulmonary fibrosis. In: European Respiratory Journal. 2010 ; Vol. 35, No. 4. pp. 821-829.
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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, Tomoko

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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