Effects of ursodeoxycholic acid (ursodiol) treatment on chronic viral hepatitis in heart transplant patients: results of a prospective, double-blind, placebo-randomized study.
BACKGROUND
Chronic viral hepatitis averages 15% to 20% in heart transplant patients. Several studies have shown that ursodiol may improve liver biochemistry in patients with chronic hepatitis. We used a double-blind randomized controlled trial to evaluate the effect of ursodiol in heart transplant patients with chronic viral hepatitis.


METHODS
Thirty heart patients with chronic viral hepatitis B, C, or non-A-G received ursodiol, 800 mg per day (group 1), and 30 received placebo (group 2) for 12 months. Endpoints were improvement in liver biochemical tests and in total Knodell score. Intent-to-treat and per-protocol analyses were performed.


RESULTS
At entry, both groups were comparable for all of the studied parameters. During the study period, serum alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transpeptidase variations were not different between group 1 and group 2 patients. Knodell score improved in 20% of group 1 patients and in 43% of group 2 patients (NS). Adverse events or mortality were not different in the two groups during the study period. Similar results were observed by intent-to-treat and per-protocol analyses.


CONCLUSIONS
A 12-month course of ursodiol therapy had no effect on liver enzymes or liver histology in heart transplant patients with chronic hepatitis.
Cadranel
Jean-François
JF
Unité d'Hépatologie, Centre Hospitalier Laennec, BP 72, 60109 Creil Cedex, France. jfrancois.cadranel@ch-creil.fr
Di Martino
Vincent
V
Dorent
Richard
R
Bernard
Brigitte
B
Hoang
Catherine
C
Myara
Anne
A
Pauwels
Arnaud
A
Ghoussoub
Jean-Jacques
JJ
Perrin
Michèle
M
Grippon
Patrick
P
Thabut
Dominique
D
Trivin
François
F
Huraux
Jean-Marie
JM
Gandjbakhch
Iradj
I
Opolon
Pierre
P
Lunel
Françoise
F
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001647:Bile Acids and Salts / Q000097:blood; D002756:Cholagogues and Choleretics / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D016027:Heart Transplantation; D019694:Hepatitis B, Chronic / Q000097:blood / Q000150:complications / Q000188:drug therapy / Q000473:pathology; D019698:Hepatitis C, Chronic / Q000097:blood / Q000150:complications / Q000188:drug therapy / Q000473:pathology; D006525:Hepatitis, Viral, Human / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000627:therapeutic use; D014580:Ursodeoxycholic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D005723:gamma-Glutamyltransferase / Q000097:blood
D001647:Bile Acids and Salts; D002756:Cholagogues and Choleretics; D010919:Placebos; D014580:Ursodeoxycholic Acid; D005723:gamma-Glutamyltransferase; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase