Vienna, Austria, Friday 16 April: Results of a German study presented today at the International Liver CongressTM 2010, the Annual Meeting of the European Association for the Study of Liver in Vienna, Austria, have shown that overall, treatment with high dose (23-28mg/kg/d) ursodeoxycholic acid (UDCA) is no more effective than placebo in the treatment of non-alcoholic steatohepatitis (NASH), the most advanced form of non-alcoholic liver disease associated with cirrhosis of the liver .
NASH is a serious development of non-alcoholic fatty liver disease (NAFLD), the most common persistent liver disorder in western countries and for which there is no proven medical therapy. Results from this study show that high dose UDCA a naturally occurring bile acid, historically used to treat gallstones is not superior to placebo therapy. Moderate histological and biochemical improvement was only observed in a subgroup of mildly overweight male patients.
Commenting on the study, Professor Fabio Marra of the EASL scientific committee said: "The use of UDCA is still considered controversial in non-alcoholic hepatitis, although previous research has suggested that the treatment may have some beneficial effects. The results of this study indicate that high dose UDCA is not superior to placebo except in a small subset of individuals. Nevertheless, the results do provide some interesting clinical pointers for clinicians in this field."
In the study, patients with histologically proven NASH (n=186, 147 of whom proceeded to treatment) were organised according to gender, body weight, liver biochemistry and histology and were randomised to receive either 23-28mg/kg/d UDCA or placebo for a period of 18 months.
Pre- and post-treatment liver biopsies from 139 patients were analysed, the primary evaluation criteria was an improvement in liver histology and secondary criteria were improvements in NASH-associated histological findings and liver function
|Contact: Isabelle Scali|
European Association for the Study of the Liver