title: Predictors of the clinical effects of pirfenidone on idiopathic pulmonary fibrosis.
abstract: BACKGROUND
  Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease with a poor prognosis. Recently, pirfenidone was reported to slow the rate of decline in vital capacity and improve progression-free survival in IPF. The purpose of this study was to clarify the factors that predicted a good response to pirfenidone, as well as its adverse effects.
  
  
  METHODS
  Forty-one IPF cases, treated with pirfenidone from January 2009 to January 2011, were enrolled in this investigation. Disease severity was classified into grades I-IV, as defined by the Japanese Respiratory Society (JRS). Short-term responsiveness to pirfenidone was evaluated by the modified criteria of the JRS. Predictors of nausea, anorexia, or both that represented important adverse effects were examined by multivariate Cox proportional hazard analyses. Predictors of short-time responsiveness were examined by multivariate logistic regression analyses.
  
  
  RESULTS
  Diagnosed by a surgical lung biopsy (SLB), the mild cases of grade I/II were predictors of good, short-term responsiveness. Patients taking acid-secretion inhibitors, including proton pump inhibitors and histamine H2-receptor antagonists, showed less anorexia, nausea, or both. Only 1 case was administered drugs to activate gastrointestinal motility.
  
  
  CONCLUSIONS
  We concluded that IPF patients with a mild disease, diagnosis by SLB, or both showed indications of a good response to pirfenidone. In addition, acid-secretion inhibitors may reduce the frequency of anorexia, nausea, or both from pirfenidone.
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization, Kinki-Chuo Chest Medical Center, 1180 Nagasone-Cho, Kita-Ku, Sakai City, Osaka 591-8555, Japan; Department of Diffuse Lung Diseases and Respiratory Failure, Clinical Research Center, National Hospital Organization, Kinki-Chuo Chest Medical Center, 1180 Nagasone-Cho, Kita-Ku, Sakai City, Osaka 591-8555, Japan. Electronic address: to-arai@kch.hosp.go.jp.
authors.forename: Toru
authors.initials: T
authors.lastname: Arai
authors.affiliation: Department of Diffuse Lung Diseases and Respiratory Failure, Clinical Research Center, National Hospital Organization, Kinki-Chuo Chest Medical Center, 1180 Nagasone-Cho, Kita-Ku, Sakai City, Osaka 591-8555, Japan. Electronic address: giichi@kch.hosp.go.jp.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Inoue
authors.affiliation: Department of Internal Medicine, National Hospital Organization, Kinki-Chuo Chest Medical Center, 1180 Nagasone-Cho, Kita-Ku, Sakai City, Osaka 591-8555, Japan. Electronic address: yusasaki@kch.hosp.go.jp.
authors.forename: Yumiko
authors.initials: Y
authors.lastname: Sasaki
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization, Kinki-Chuo Chest Medical Center, 1180 Nagasone-Cho, Kita-Ku, Sakai City, Osaka 591-8555, Japan; Department of Diffuse Lung Diseases and Respiratory Failure, Clinical Research Center, National Hospital Organization, Kinki-Chuo Chest Medical Center, 1180 Nagasone-Cho, Kita-Ku, Sakai City, Osaka 591-8555, Japan. Electronic address: ktachiba@kch.hosp.go.jp.
authors.forename: Kazunobu
authors.initials: K
authors.lastname: Tachibana
authors.affiliation: Department of Internal Medicine, National Hospital Organization, Kinki-Chuo Chest Medical Center, 1180 Nagasone-Cho, Kita-Ku, Sakai City, Osaka 591-8555, Japan. Electronic address: keinakao@kch.hosp.go.jp.
authors.forename: Keiko
authors.initials: K
authors.lastname: Nakao
authors.affiliation: Division of Clinical Trial, National Hospital Organization, Kinki-Chuo Chest Medical Center, 1180 Nagasone-Cho, Kita-Ku, Sakai City, Osaka 591-8555, Japan. Electronic address: sugimoto@kch.hosp.go.jp.
authors.forename: Chikatoshi
authors.initials: C
authors.lastname: Sugimoto
authors.affiliation: Department of Radiology, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-Machi, Abeno-Ku, Osaka City, Osaka 545-8585, Japan. Electronic address: o-kuma@msic.med.osaka-cu.ac.jp.
authors.forename: Tomohisa
authors.initials: T
authors.lastname: Okuma
authors.affiliation: Department of Radiology, National Hospital Organization, Kinki-Chuo Chest Medical Center, 1180 Nagasone-Cho, Kita-Ku, Sakai City, Osaka 591-8555, Japan. Electronic address: akira@kch.hosp.go.jp.
authors.forename: Masanori
authors.initials: M
authors.lastname: Akira
authors.affiliation: Department of Pathology, National Hospital Organization, Kinki-Chuo Chest Medical Center, 1180 Nagasone-Cho, Kita-Ku, Sakai City, Osaka 591-8555, Japan. Electronic address: kitaichi@kch.hosp.go.jp.
authors.forename: Masanori
authors.initials: M
authors.lastname: Kitaichi
authors.affiliation: Department of Internal Medicine, National Hospital Organization, Kinki-Chuo Chest Medical Center, 1180 Nagasone-Cho, Kita-Ku, Sakai City, Osaka 591-8555, Japan. Electronic address: shayashi@kch.hosp.go.jp.
authors.forename: Seiji
authors.initials: S
authors.lastname: Hayashi
mesh_terms: D000368:Aged; D000855:Anorexia / Q000139:chemically induced / Q000517:prevention & control; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006635:Histamine H2 Antagonists / Q000008:administration & dosage; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D054328:Proton Pump Inhibitors / Q000008:administration & dosage; D011728:Pyridones / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D012720:Severity of Illness Index; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D014797:Vital Capacity
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D006635:Histamine H2 Antagonists; D054328:Proton Pump Inhibitors; D011728:Pyridones; C093844:pirfenidone
keywords: Acid-secretion inhibitors; Anorexia; Idiopathic pulmonary fibrosis; Pirfenidone