Abstract | BACKGROUND: METHODS: The patients in the phase III trial were stratified by baseline percentage predicted vital capacity (%VC), arterial oxygen partial pressure (PaO(2)), and the lowest oxygen saturation by pulse oximetry (SpO(2)) during the 6-minute steady-state exercise test (6MET). In the subpopulations, changes in VC and subjective symptoms ( cough and dyspnea on the Fletcher, Hugh-Jones [F, H-J] Classification scale) were evaluated in patients treated with high-dose (1800 mg/day) pirfenidone, low-dose (1200 mg/day) pirfenidone, and placebo at week 52. RESULTS: Significant efficacy of pirfenidone in reducing the decline in VC could be seen in a subpopulation having %VC ≥ 70% and SpO(2) < 90% at baseline. This favorable effect was accompanied by categorical change in VC and progression-free survival time. In the subpopulation, pirfenidone significantly suppressed cough and dyspnea. CONCLUSIONS: IPF patients having %VC ≥ 70% and SpO(2) < 90% at baseline will most likely benefit from pirfenidone when evaluated using changes in VC (and %VC), and cough and dyspnea symptoms. This subpopulation could expect to benefit most from pirfenidone treatment. TRIAL REGISTRATION: This clinical trial was registered with the Japan Pharmaceutical Information Center (JAPIC) on September 13th, 2005 (REGISTRATION NUMBER: JAPICCTI-050121).
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Authors | Arata Azuma, Yoshio Taguchi, Takashi Ogura, Masahito Ebina, Hiroyuki Taniguchi, Yasuhiro Kondoh, Moritaka Suga, Hiroki Takahashi, Koichiro Nakata, Atsuhiko Sato, Shoji Kudoh, Toshihiro Nukiwa, Pirfenidone Clinical Study Group in Japan |
Journal | Respiratory research
(Respir Res)
Vol. 12
Pg. 143
(Oct 28 2011)
ISSN: 1465-993X [Electronic] England |
PMID | 22035508
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Adult
- Aged
- Double-Blind Method
- Female
- Humans
- Idiopathic Pulmonary Fibrosis
(diagnosis, drug therapy, physiopathology)
- Male
- Middle Aged
- Pyridones
(therapeutic use)
- Treatment Outcome
- Vital Capacity
(drug effects, physiology)
- Young Adult
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