Pirfenidone in idiopathic pulmonary fibrosis
Kyoto Medical Center · Sapporo Medical University Hospital · +8 more institutions
Abstract
Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease without proven effective therapy. A multicentre, double-blind, placebo-controlled, randomised phase III clinical trial was conducted in Japanese patients with well-defined IPF to determine the efficacy and safety of pirfenidone, a novel antifibrotic oral agent, over 52 weeks. Of 275 patients randomised (high-dose, 1,800 mg x day(-1); low-dose, 1,200 mg x day(-1); or placebo groups in the ratio 2:1:2), 267 patients were evaluated for the efficacy of pirfenidone. Prior to unblinding, the primary end-point was revised; the change in vital capacity (VC) was assessed at week 52. Secondary end-points included the progression-free survival (PFS) time.…
Citation impact
- FWCI
- 32.74
- Percentile
- 100%
- References
- 26
Authors
14- HTH. TaniguchiCorresponding
Kyoto Medical Center, Sapporo Medical University Hospital, Tosei General Hospital
- MEMasahito Ebina
Tohoku University, Kanagawa Cardiovascular and Respiratory Center
- YKYasuhiro Kondoh
Kyoto Medical Center, Sapporo Medical University Hospital, Tosei General Hospital
- TOT. Ogura
Tohoku University
- AAArata Azuma
Nippon Medical School
Topics & keywords
- Pirfenidone
- Medicine
- Idiopathic pulmonary fibrosis
- Placebo
- Clinical endpoint
- Adverse effect
- Internal medicine
- Gastroenterology
Funding
- SCSaitama Cardiovascular and Respiratory Center
- KUKanazawa University
- UOUniversity of Miyazaki Hospital
- KUKeio University
- DMDokkyo Medical University
- JMJichi Medical University
- FUFukuoka University
- SShionogi
- UOUniversity of Tokushima
- NMNara Medical University
- HUHokkaido University
- TMTokyo Medical and Dental University
- CUChiba University
- NCNagoya City University
- TWTokyo Women's Medical University