Bezafibrate may have a beneficial effect in pre-cirrhotic primary biliary cirrhosis

Bezafibrate is a commonly used medicine for hyperlipidemia and is known to have an effect of lowering biliary enzymes, alkaline phosphatase (ALP) and gamma-glutamyltransferase. Recent studies showed that it upregulated mdr2/MDR3 P-glycoprotein expression which increased biliary phospholipid secretion into bile and had a cyto-protective effect against cholestasis. To evaluate the efficacy of bezafibrate in primary biliary cirrhosis(PBC), 11 pre-cirrhotic PBC patients were treated with oral administration of 400 mg/day of bezafibrate for 12-21 months. One of them was stage III and the rest was stage I-II. Two patients had pruritus and chronic fatigue, and two chronic fatigue. Bezafibrate was co-administered in seven patients who had been treated with ursodeoxycholic acid but shown incomplete responses. In 11 patients, values of ALP decreased by 50-70% and were normalized in five. After 2 months from the start, all symptoms lessened and eventually disappeared as biliary enzymes levels decreased. As for the immunological parameters, IgM decreased significantly in five patients but antimitochondrial antibody titers were not affected. The present data suggest that bezafibrate has additional effects and is safe for pre-cirrhotic primary biliary cirrhosis. The evaluations of long-term efficacy and toxicity including histological changes are needed. (C) 1999 Elsevier Science Ireland Ltd. All rights reserved.