Clinical utility of ursodeoxycholic acid in preventing flutamide-induced hepatopathy in patients with prostate cancer: a preliminary study.
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.
Kojima
Munekado
M
Department of Urology, Kyoto Prefectural University of Medicine, Japan. mkojima@cg7.so-net.ne.jp
Kamoi
Kazumi
K
Ukimura
Osamu
O
Fujito
Akira
A
Nakao
Masahiro
M
Tanaka
Shigeki
S
Miyashita
Hiroaki
H
Iwamoto
Noriyuki
N
Ohe
Hiroshi
H
Kitamori
Tomohito
T
Date
Seiki
S
Kitamura
Koji
K
Araki
Hirotaka
H
Aoki
Tadashi
T
Imada
Naoki
N
Takada
Hitoshi
H
Imaide
Yoichiroh
Y
Mikami
Kazuya
K
Uchida
Mutsumi
M
Saitoh
Masahito
M
Miki
Tsuneharu
T
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*
D018931:Antineoplastic Agents, Hormonal; D014580:Ursodeoxycholic Acid; D005485:Flutamide