title: Clinical utility of ursodeoxycholic acid in preventing flutamide-induced hepatopathy in patients with prostate cancer: a preliminary study.
abstract: BACKGROUND
  The present study was designed to ascertain retrospectively the validity of ursodeoxycholic acid (UDCA) in the treatment of prostate cancer in terms of prophylactic effects on the occurrence of flutamide-induced hepatopathy in a large number of patients surveyed in a multi-center cooperative study.
  
  
  METHODS
  One hundred and eighty-one patients (74.1 +/- 4.9 years) with prostate cancer treated with flutamide with (n = 70) or without (n = 111) UDCA were retrospectively evaluated and the occurrence of hepatopathy was compared between these two patient groups.
  
  
  RESULTS
  Between patients treated with UDCA and those without it, no significant differences were noted in age, clinical stage, grade, duration of flutamide administration and serum prostate-specific antigen (PSA) levels before treatment. However, there were significant differences in the presence or absence of previous treatments and treatments used together with flutamide. The incidence of hepatopathy was 11.4% (8/70) in patients with UDCA and 32.4% (36/111) in those without it, showing a statistically significant difference (P < 0.05). The hepatopathy-free rate obtained by the Kaplan-Meier method was also significantly higher in patients with UDCA (88.4% 1 year following flutamide administration) than that in those without it (59.6%) (P < 0.005).
  
  
  CONCLUSIONS
  These results suggest that UDCA has a prophylactic effect against flutamide-induced hepatopathy in patients with prostate cancer.
authors.affiliation: Department of Urology, Kyoto Prefectural University of Medicine, Japan. mkojima@cg7.so-net.ne.jp
authors.forename: Munekado
authors.initials: M
authors.lastname: Kojima
authors.forename: Kazumi
authors.initials: K
authors.lastname: Kamoi
authors.forename: Osamu
authors.initials: O
authors.lastname: Ukimura
authors.forename: Akira
authors.initials: A
authors.lastname: Fujito
authors.forename: Masahiro
authors.initials: M
authors.lastname: Nakao
authors.forename: Shigeki
authors.initials: S
authors.lastname: Tanaka
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Miyashita
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Iwamoto
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ohe
authors.forename: Tomohito
authors.initials: T
authors.lastname: Kitamori
authors.forename: Seiki
authors.initials: S
authors.lastname: Date
authors.forename: Koji
authors.initials: K
authors.lastname: Kitamura
authors.forename: Hirotaka
authors.initials: H
authors.lastname: Araki
authors.forename: Tadashi
authors.initials: T
authors.lastname: Aoki
authors.forename: Naoki
authors.initials: N
authors.lastname: Imada
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Takada
authors.forename: Yoichiroh
authors.initials: Y
authors.lastname: Imaide
authors.forename: Kazuya
authors.initials: K
authors.lastname: Mikami
authors.forename: Mutsumi
authors.initials: M
authors.lastname: Uchida
authors.forename: Masahito
authors.initials: M
authors.lastname: Saitoh
authors.forename: Tsuneharu
authors.initials: T
authors.lastname: Miki
mesh_terms: D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects*; D056486:Chemical and Drug Induced Liver Injury; D005485:Flutamide / Q000009:adverse effects*; D006801:Humans; D008107:Liver Diseases / Q000517:prevention & control*; D008297:Male; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D012189:Retrospective Studies; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
chemical_list: D018931:Antineoplastic Agents, Hormonal; D014580:Ursodeoxycholic Acid; D005485:Flutamide