Premium
Bezafibrate normalizes alkaline phosphatase in primary biliary cirrhosis patients with incomplete response to ursodeoxycholic acid
Author(s) -
Lens Sabela,
Leoz María,
Nazal Leyla,
Bruguera Miguel,
Parés Albert
Publication year - 2014
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.12290
Subject(s) - bezafibrate , ursodeoxycholic acid , medicine , gastroenterology , discontinuation , alkaline phosphatase , endocrinology , cholestasis , adverse effect , primary biliary cirrhosis , chemistry , biochemistry , enzyme
Abstract Background & Aims Ursodeoxycholic 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 . Methods Thirty women (age 52.3 ± 2.3 years) treated with UDCA and abnormal alkaline phosphatase ( AP ) levels received bezafibrate (400 mg/d) for 1 year. Changes were measured every 3 months during the study period of 12 months, 3 months after discontinuation and 3 months after resuming bezafibrate. Results Two patients discontinued the treatment after few days, three at 6 and one at 9 months. Bezafibrate treatment resulted in a significant decrease in AP as early as 3 months. Normalization or decrease of AP below 1.5 times normal levels was observed in 13 and 4 patients respectively. There was also a significant decrease in γ‐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. Conclusions Combination treatment of bezafibrate and UDCA is associated with marked decrease or normalization of alkaline phosphatase as early as 3 months in patients with PBC . Better biochemical response was observed in patients with early disease and lower cholestasis.