Bezafibrate normalizes alkaline phosphatase in primary biliary cirrhosis patients with incomplete response to ursodeoxycholic acid

Background & AimsUrsodeoxycholic acid (UDCA) is the standard treatment for primary biliary cirrhosis (PBC) but excellent response is not observed in all cases. Since potential favourable effects of fibrates have been reported in short series with inconclusive results, we have carried out a pilot study to analyse the effects of bezafibrate in patients with suboptimal response to UDCA. MethodsThirty women (age 52.32.3years) treated with UDCA and abnormal alkaline phosphatase (AP) levels received bezafibrate (400mg/d) for 1year. Changes were measured every 3months during the study period of 12months, 3months after discontinuation and 3months after resuming bezafibrate. ResultsTwo patients discontinued the treatment after few days, three at 6 and one at 9months. Bezafibrate treatment resulted in a significant decrease in AP as early as 3months. Normalization or decrease of AP below 1.5times normal levels was observed in 13 and 4 patients respectively. There was also a significant decrease in -glutamyl transferase and alanine aminotransferase, cholesterol and triglyceride levels. Bezafibrate treatment resulted in significant improvement of pruritus. A rebound in liver biochemistries and pruritus occurred upon drug discontinuation, changes which improved again after resuming bezafibrate. Response to bezafibrate was associated with lower liver stiffness and severity of cholestasis. No severe adverse effects were observed. ConclusionsCombination treatment of bezafibrate and UDCA is associated with marked decrease or normalization of alkaline phosphatase as early as 3months in patients with PBC. Better biochemical response was observed in patients with early disease and lower cholestasis.