The long-term effect of ursodeoxycholic acid on  laboratory liver parameters in biochemically  non-advanced primary biliary cirrhosis.
OBJECTIVE
Ursodeoxycholic acid (UDCA) has an established effect on liver bio-chemistries in primary biliary cirrhosis (PBC). Few studies have evaluated long-term laboratory treatment effects and data beyond 6 years are not available. The aim of this study was to assess the long-term evolution of liver bio-chemistries during prolonged treatment with UDCA in biochemically non-advanced PBC.


METHODS
Prospective multicenter cohort study of patients with PBC with pretreatment normal bilirubin and albumin, treated with UDCA 13-15 mg/kg/day. At yearly intervals, follow-up data including serum bilirubin, alkaline phosphatase (ALP), transaminases, albumin and IgM were collected. Data were analyzed with a repeated measurement model.


RESULTS
Two hundred and twenty-five patients were included and followed during a median period of 10.3 years. Following 1-year treatment with UDCA 36-100% of the total biochemical improvement was achieved, the maximum response was observed after 3 years. After initial improvements, bilirubin and AST levels increased and albumin levels significantly decreased after 6-10 years. However, these changes were of limited magnitude. The beneficial effects on ALT and ALP were maintained while IgM continued to decrease.


CONCLUSIONS
In non-advanced PBC the biochemical response to UDCA is maintained up to 15 years. The long-term evolution of bilirubin, albumin and ALT differs from that of ALP and AST. The mean IgM level normalised and levels continued to decrease during the period of follow-up.
Kuiper
E M M
EM
Department of Gastroenterology and Hepatology, Rotterdam, The Netherlands.
Hansen
B E
BE
Lesterhuis
W
W
Robijn
R J
RJ
Thijs
J C
JC
Engels
L G J B
LG
Koek
G H
GH
Aparicio
M N
MN
Kerbert-Dreteler
M J
MJ
van Buuren
H R
HR
D002756:Cholagogues and Choleretics / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008099:Liver / Q000187:drug effects* / Q000503:physiopathology; D008105:Liver Cirrhosis, Biliary / Q000188:drug therapy* / Q000378:metabolism; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D014580:Ursodeoxycholic Acid / Q000494:pharmacology / Q000627:therapeutic use*
D002756:Cholagogues and Choleretics; D014580:Ursodeoxycholic Acid