The clinical significance of 5% change in vital capacity in patients with idiopathic pulmonary fibrosis: extended analysis of the pirfenidone trial
<p>Abstract</p> <p>Background</p> <p>Our phase III clinical trial of pirfenidone for patients with idiopathic pulmonary fibrosis (IPF) revealed the efficacy in reducing the decline of vital capacity (VC) and increasing the progression-free survival (PFS) time by pirfeni...
Main Authors: | , , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
BMC
2011-07-01
|
Series: | Respiratory Research |
Online Access: | http://respiratory-research.com/content/12/1/93 |
id |
doaj-09e46fe532444a6689cce6e9c004e8be |
---|---|
record_format |
Article |
spelling |
doaj-09e46fe532444a6689cce6e9c004e8be2020-11-25T02:45:13ZengBMCRespiratory Research1465-99212011-07-011219310.1186/1465-9921-12-93The clinical significance of 5% change in vital capacity in patients with idiopathic pulmonary fibrosis: extended analysis of the pirfenidone trialNakata KoichiroTakahashi HirokiSuga MoritakaTaguchi YoshioOgura TakashiAzuma ArataEbina MasahitoKondoh YasuhiroTaniguchi HiroyukiSato AtsuhikoSugiyama YukihikoKudoh ShojiNukiwa Toshihiro<p>Abstract</p> <p>Background</p> <p>Our phase III clinical trial of pirfenidone for patients with idiopathic pulmonary fibrosis (IPF) revealed the efficacy in reducing the decline of vital capacity (VC) and increasing the progression-free survival (PFS) time by pirfenidone. Recently, marginal decline in forced VC (FVC) has been reported to be associated with poor outcome in IPF. We sought to evaluate the efficacy of pirfenidone from the aspects of 5% change in VC.</p> <p>Methods</p> <p>Improvement ratings based on 5% change in absolute VC, i.e., "improved (VC ≥ 5% increase)", "stable (VC < 5% change)", and "worsened (VC ≥ 5% decrease)" at month 3, 6, 9 and 12 were compared between high-dose pirfenidone (1800 mg/day; n = 108) and placebo (n = 104) groups, and (high-dose and low-dose (1200 mg/day; n = 55)) pirfenidone (n = 163) and placebo groups. PFS times with defining the disease progression as death or a ≥ 5% decline in VC were also compared between high-dose pirfenidone and placebo groups, and low-dose pirfenidone and placebo groups. Furthermore, considering "worsened" and "non-worsened (improved and stable)" of the ratings at months 3 and 12 as "positive" and "negative", respectively, and the positive and negative predictive values of the ratings were calculated in each group.</p> <p>Results</p> <p>In the comparison of the improvement ratings, the statistically significant differences were clearly revealed at months 3, 6, 9, and 12 between pirfenidone and placebo groups. Risk reductions by pirfenidone to placebo were approximately 35% over the study period. In the comparison of the PFS times, statistically significant difference was also observed between pirfenidone and placebo groups. The positive/negative predictive values in placebo and pirfenidone groups were 86.1%/50.8% and 87.1%/71.7%, respectively. Further, the baseline characteristics of patients worsened at month 3 had generally severe impairment, and their clinical outcomes including mortality were also significantly worsened after 1 year.</p> <p>Conclusions</p> <p>The efficacy of pirfenidone in Japanese phase III trial was supported by the rating of 5% decline in VC, and the VC changes at month 3 may be used as a prognostic factor of IPF.</p> <p>Trial Registration</p> <p>This clinical trial was registered with the Japan Pharmaceutical Information Center (JAPIC) on September 13<sup>th</sup>, 2005 (Registration Number: JAPICCTI-050121).</p> http://respiratory-research.com/content/12/1/93 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Nakata Koichiro Takahashi Hiroki Suga Moritaka Taguchi Yoshio Ogura Takashi Azuma Arata Ebina Masahito Kondoh Yasuhiro Taniguchi Hiroyuki Sato Atsuhiko Sugiyama Yukihiko Kudoh Shoji Nukiwa Toshihiro |
spellingShingle |
Nakata Koichiro Takahashi Hiroki Suga Moritaka Taguchi Yoshio Ogura Takashi Azuma Arata Ebina Masahito Kondoh Yasuhiro Taniguchi Hiroyuki Sato Atsuhiko Sugiyama Yukihiko Kudoh Shoji Nukiwa Toshihiro The clinical significance of 5% change in vital capacity in patients with idiopathic pulmonary fibrosis: extended analysis of the pirfenidone trial Respiratory Research |
author_facet |
Nakata Koichiro Takahashi Hiroki Suga Moritaka Taguchi Yoshio Ogura Takashi Azuma Arata Ebina Masahito Kondoh Yasuhiro Taniguchi Hiroyuki Sato Atsuhiko Sugiyama Yukihiko Kudoh Shoji Nukiwa Toshihiro |
author_sort |
Nakata Koichiro |
title |
The clinical significance of 5% change in vital capacity in patients with idiopathic pulmonary fibrosis: extended analysis of the pirfenidone trial |
title_short |
The clinical significance of 5% change in vital capacity in patients with idiopathic pulmonary fibrosis: extended analysis of the pirfenidone trial |
title_full |
The clinical significance of 5% change in vital capacity in patients with idiopathic pulmonary fibrosis: extended analysis of the pirfenidone trial |
title_fullStr |
The clinical significance of 5% change in vital capacity in patients with idiopathic pulmonary fibrosis: extended analysis of the pirfenidone trial |
title_full_unstemmed |
The clinical significance of 5% change in vital capacity in patients with idiopathic pulmonary fibrosis: extended analysis of the pirfenidone trial |
title_sort |
clinical significance of 5% change in vital capacity in patients with idiopathic pulmonary fibrosis: extended analysis of the pirfenidone trial |
publisher |
BMC |
series |
Respiratory Research |
issn |
1465-9921 |
publishDate |
2011-07-01 |
description |
<p>Abstract</p> <p>Background</p> <p>Our phase III clinical trial of pirfenidone for patients with idiopathic pulmonary fibrosis (IPF) revealed the efficacy in reducing the decline of vital capacity (VC) and increasing the progression-free survival (PFS) time by pirfenidone. Recently, marginal decline in forced VC (FVC) has been reported to be associated with poor outcome in IPF. We sought to evaluate the efficacy of pirfenidone from the aspects of 5% change in VC.</p> <p>Methods</p> <p>Improvement ratings based on 5% change in absolute VC, i.e., "improved (VC ≥ 5% increase)", "stable (VC < 5% change)", and "worsened (VC ≥ 5% decrease)" at month 3, 6, 9 and 12 were compared between high-dose pirfenidone (1800 mg/day; n = 108) and placebo (n = 104) groups, and (high-dose and low-dose (1200 mg/day; n = 55)) pirfenidone (n = 163) and placebo groups. PFS times with defining the disease progression as death or a ≥ 5% decline in VC were also compared between high-dose pirfenidone and placebo groups, and low-dose pirfenidone and placebo groups. Furthermore, considering "worsened" and "non-worsened (improved and stable)" of the ratings at months 3 and 12 as "positive" and "negative", respectively, and the positive and negative predictive values of the ratings were calculated in each group.</p> <p>Results</p> <p>In the comparison of the improvement ratings, the statistically significant differences were clearly revealed at months 3, 6, 9, and 12 between pirfenidone and placebo groups. Risk reductions by pirfenidone to placebo were approximately 35% over the study period. In the comparison of the PFS times, statistically significant difference was also observed between pirfenidone and placebo groups. The positive/negative predictive values in placebo and pirfenidone groups were 86.1%/50.8% and 87.1%/71.7%, respectively. Further, the baseline characteristics of patients worsened at month 3 had generally severe impairment, and their clinical outcomes including mortality were also significantly worsened after 1 year.</p> <p>Conclusions</p> <p>The efficacy of pirfenidone in Japanese phase III trial was supported by the rating of 5% decline in VC, and the VC changes at month 3 may be used as a prognostic factor of IPF.</p> <p>Trial Registration</p> <p>This clinical trial was registered with the Japan Pharmaceutical Information Center (JAPIC) on September 13<sup>th</sup>, 2005 (Registration Number: JAPICCTI-050121).</p> |
url |
http://respiratory-research.com/content/12/1/93 |
work_keys_str_mv |
AT nakatakoichiro theclinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT takahashihiroki theclinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT sugamoritaka theclinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT taguchiyoshio theclinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT oguratakashi theclinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT azumaarata theclinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT ebinamasahito theclinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT kondohyasuhiro theclinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT taniguchihiroyuki theclinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT satoatsuhiko theclinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT sugiyamayukihiko theclinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT kudohshoji theclinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT nukiwatoshihiro theclinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT nakatakoichiro clinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT takahashihiroki clinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT sugamoritaka clinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT taguchiyoshio clinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT oguratakashi clinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT azumaarata clinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT ebinamasahito clinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT kondohyasuhiro clinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT taniguchihiroyuki clinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT satoatsuhiko clinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT sugiyamayukihiko clinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT kudohshoji clinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial AT nukiwatoshihiro clinicalsignificanceof5changeinvitalcapacityinpatientswithidiopathicpulmonaryfibrosisextendedanalysisofthepirfenidonetrial |
_version_ |
1724763519899926528 |