Efficacy of pirfenidone and disease severity of idiopathic pulmonary fibrosis: Extended analysis of phase III trial in Japan Yoshio Taguchi, Masahito.

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Efficacy of pirfenidone and disease severity of idiopathic pulmonary fibrosis: Extended analysis of phase III trial in Japan Yoshio Taguchi, Masahito Ebina, Seishu Hashimoto, Takashi Ogura, Arata Azuma, Hiroyuki Taniguchi, Yasuhiro Kondoh, Moritaka Suga, Hiroki Takahashi, Koichiro Nakata, Yukihiko Sugiyama, Shoji Kudoh, Toshihiro Nukiwa Respiratory Investigation Volume 53, Issue 6, Pages 279-287 (November 2015) DOI: 10.1016/j.resinv.2015.06.002 Copyright © 2015 Terms and Conditions

Fig. 1 Classification of baseline pulmonary functions in patient sub-populations by disease severity. (A) The lowest oxygen saturation (SpO2) on exertion, (B) % vital capacity (VC), (C) % diffusion capacity for carbon monoxide (DLco), and (D) arterial oxygen partial pressure (PaO2) at rest. Data are shown as mean (±SE). High-dose (1800mg/day) pirfenidone (black columns), low-dose (1200mg/day) pirfenidone (gray columns), and placebo (white columns). *p<0.001. Respiratory Investigation 2015 53, 279-287DOI: (10.1016/j.resinv.2015.06.002) Copyright © 2015 Terms and Conditions

Fig. 2 Change in vital capacity (VC) from baseline to week 52 in patient sub-populations with mild to severe IPF. (A) Mild, (B) moderate, and (C) severe IPF. Data are shown as mean (±SE). High-dose pirfenidone (black columns), low-dose pirfenidone (gray columns), and placebo (white columns). *p<0.05, comparison of adjusted means based on analysis of covariance (ANCOVA). Respiratory Investigation 2015 53, 279-287DOI: (10.1016/j.resinv.2015.06.002) Copyright © 2015 Terms and Conditions

Fig. 3 Analysis of changes in vital capacity (VC) from baseline to week 52 with mixed model repeated-measures (MMRM). (A) Mild, (B) moderate, and (C) severe IPF. Data are shown as mean±SE. High-dose pirfenidone (black columns), low-dose pirfenidone (gray columns), and placebo (white columns). *p<0.05. Respiratory Investigation 2015 53, 279-287DOI: (10.1016/j.resinv.2015.06.002) Copyright © 2015 Terms and Conditions

Fig. 4 Progression-free survival (PFS) in patient sub-populations with mild to severe IPF. (A) Mild, (B) moderate, and (C) severe IPF. High-dose pirfenidone (solid line), low-dose pirfenidone (broken line), and placebo (bold broken line). PFS was estimated by the Kaplan–Meier method. Respiratory Investigation 2015 53, 279-287DOI: (10.1016/j.resinv.2015.06.002) Copyright © 2015 Terms and Conditions