Risk factors for acute exacerbation of idiopathic pulmonary fibrosis - Extended analysis of pirfenidone trial in Japan

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• 作者：Yasuhiro Kondoh^a ; ^{konyasu2003@yahoo.co.jp" class="auth_mail" title="E-mail the corresponding author} ; Hiroyuki Taniguchi^a ; ^{taniguchi@tosei.or.jp" class="auth_mail" title="E-mail the corresponding author} ; ^{hiro-tosei-lung@kkd.biglobe.ne.jp" class="auth_mail" title="E-mail the corresponding author} ; Masahito Ebina^b ; ^{ebinam@hosp.tohoku-pharm.ac.jp" class="auth_mail" title="E-mail the corresponding author} ; Arata Azuma^c ; ^{azuma_arata@yahoo.co.jp" class="auth_mail" title="E-mail the corresponding author} ; Takashi Ogura^d ; ^{Ogura@kanagawa-junko.jp" class="auth_mail" title="E-mail the corresponding author} ; Yoshio Taguchi^e ; ^{ytaguchi@tenriyorozu.jp" class="auth_mail" title="E-mail the corresponding author} ; Moritaka Suga^f ; ^{suga-taka-0825@rose.odn.ne.jp" class="auth_mail" title="E-mail the corresponding author} ; Hiroki Takahashi^g ; ^{htaka@sapmed.ac.jp" class="auth_mail" title="E-mail the corresponding author} ; Koichiro Nakata^h ; ^{nakata@nakata-clinic.jp" class="auth_mail" title="E-mail the corresponding author} ; Yukihiko Sugiyamaⁱ ; ^{sugiyuki@jichi.ac.jp" class="auth_mail" title="E-mail the corresponding author} ; Shoji Kudoh^c ; ^j ; ^{kudous@fukujuji.org" class="auth_mail" title="E-mail the corresponding author} ; Toshihiro Nukiwa^b ; ^k ; ^{toshinkw47@gmail.com" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Idiopathic pulmonary fibrosis (IPF) ; Acute exacerbation ; Absolute decline in VC ; Relative decline in VC ; Risk factor
• 刊名：Respiratory Investigation
• 出版年：2015
• 出版时间：November 2015
• 年：2015
• 卷：53
• 期：6
• 页码：271-278
• 全文大小：436 K

文摘

Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a lifethreatening event and one of the important endpoints in clinical trials involving IPF. Despite this, there has been little evaluation of the potential risk factors for AE-IPF in clinical trials. We evaluated the risk factors for AE-IPF in a phase III clinical trial of pirfenidone in Japanese IPF patients.

<h4 id="absSec_2">Methodsh4>

The study population comprised 267 patients. The effects of various baseline characteristics as possible risk factors for AE-IPF during the study, as well as those of a ≥10% decline in percent vital capacity (%VC) within 6 months, were evaluated using Cox壮s proportional hazard model. The ≥10% decline in %VC was calculated in two ways: (1) an absolute decline (e.g. from 60% predicted to 50%); and (2) a relative decline (e.g. from 60% predicted to 54%).

<h4 id="absSec_3">Resultsh4>

Over 52 weeks, 14 patients experienced AE-IPF. Univariate analysis using Cox壮s proportional hazards model showed that both relative and absolute ≥10% decline in %VC within 6 months were significant risk factors for AE-IPF. Stepwise multivariate analysis demonstrated that absolute or relative decline in both %VC and alveolar to arterial oxygen pressure difference (AaDO₂) were significant risk factors for AE. The model using absolute decline [Hazard Ration (HR)=7.405, p=0.0007] and baseline AaDO₂ (HR=1.063, p=0.0266) had a better fit than the model using relative decline and baseline AaDO₂.

<h4 id="absSec_4">Conclusionsh4>

Rapid %VC decline (≥10% within 6 months), and high baseline AaDO₂, may be risk factors for AE-IPF.