title: Cyclosporine A combined with low-dose corticosteroid treatment in patients with idiopathic pulmonary fibrosis.
abstract: BACKGROUND
  It has been reported that cyclosporine A (CYA) treatment may benefit idiopathic pulmonary fibrosis (IPF) patients. We conducted a randomized, controlled trial at 27 centers across Japan to evaluate the efficacy and safety of CYA with low-dose corticosteroids (CS) for IPF treatment. We compared these findings with others obtained using cyclophosphamide (CPA) combined with low-dose CS: the current standard therapy for IPF.
  
  
  METHODS
  The study involved patients between 50 and 74 years of age with well-defined IPF. The primary endpoint was a change in forced vital capacity (FVC) between baseline and 48 weeks.
  
  
  RESULTS
  We started this trial in May 2005 and ended it in December 2008. Ninety-nine patients were enrolled in the study. There was no significant difference between the CYA and CPA groups with regard to the change in FVC between baseline and 48 weeks (-0.078L and -0.087L, respectively). Neither did the two groups differ significantly with regard to the incidence rates of several adverse events.
  
  
  CONCLUSIONS
  This clinical trial revealed no significant differences between the CYA group and the CPA group with regard to either safety data or the primary endpoint. However, the trial should be regarded as inconclusive because of its small sample size. There was a trend toward a reduction in FVC decline per year when the trial groups were compared with the placebo groups of previous studies, despite patients in this study having severely impaired lung function. Both therapies were well tolerated and lacked serious adverse effects.
authors.affiliation: Tokyo Medical and Dental University, Tokyo, Japan. Electronic address: miyazaki.pilm@tmd.ac.jp.
authors.forename: Yasunari
authors.initials: Y
authors.lastname: Miyazaki
authors.affiliation: Nippon Medical School, Tokyo, Japan. Electronic address: a-azuma@nms.ac.jp.
authors.forename: Arata
authors.initials: A
authors.lastname: Azuma
authors.affiliation: Tokyo Medical and Dental University, Tokyo, Japan. Electronic address: ninase.pulm@tmd.ac.jp.
authors.forename: Naohiko
authors.initials: N
authors.lastname: Inase
authors.affiliation: Tosei General Hospital, Aichi, Japan. Electronic address: taniguchi@tosei.or.jp.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Taniguchi
authors.affiliation: Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan. Electronic address: ogura@kanagawa-junko.jp.
authors.forename: Takashi
authors.initials: T
authors.lastname: Ogura
authors.affiliation: National Center for Child Health and Development, Tokyo, Japan. Electronic address: inoue-ei@ncchd.go.jp.
authors.forename: Eisuke
authors.initials: E
authors.lastname: Inoue
authors.affiliation: Kitasato University, Tokyo, Japan. Electronic address: takeuchim@pharm.kitasato-u.ac.jp.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Takeuchi
authors.affiliation: Tokyo Medical and Dental University, Tokyo, Japan. Electronic address: yoshizawa.pulm@tmd.ac.jp.
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Yoshizawa
authors.affiliation: Jichi Medical University, Tochigi, Japan. Electronic address: sugiyuki@jichi.ac.jp.
authors.forename: Yukihiko
authors.initials: Y
authors.lastname: Sugiyama
authors.affiliation: Fukujuji Hospital, Anti-Tuberculosis Association, Tokyo, Japan. Electronic address: kudous@fukujuji.org.
authors.forename: Shoji
authors.initials: S
authors.lastname: Kudoh
mesh_terms: D000368:Aged; D016572:Cyclosporine / Q000008:administration & dosage*; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000188:drug therapy* / Q000503:physiopathology; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007564:Japan; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage*; D016896:Treatment Outcome; D014797:Vital Capacity
chemical_list: D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D011239:Prednisolone
keywords: Corticosteroid; Cyclophosphamide; Cyclosporine; IPF; RCT