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BioMed Central, Respiratory Research, 1(12), p. 93

DOI: 10.1186/1465-9921-12-93

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The clinical significance of 5% change in vital capacity in patients with idiopathic pulmonary fibrosis: extended analysis of the pirfenidone trial

Journal article published in 2011 by Hiroyuki Taniguchi, Yasuhiro Kondoh, Masahito Ebina, Arata Azuma ORCID, Takashi Ogura, Yoshio Taguchi, Moritaka Suga, Hiroki Takahashi, Koichiro Nakata, Atsuhiko Sato, Yukihiko Sugiyama, Shoji Kudoh, Toshihiro Nukiwa, Pirfenidone Clinical Study Group in Japan
This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

Abstract Background 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. Methods Improvement ratings based on 5% change in absolute VC, i.e., "improved (VC ≥ 5% increase)", "stable (VC