Fenofibrate in primary biliary cirrhosis: a pilot study

Most patients with primary biliary cirrhosis (PBC) are treated with ursodeoxycholic acid (UDCA); however, some do not respond fully. PBC is also associated with dyslipidemia, but a link with vascular risk has not been confirmed. In this study we compared UDCA monotherapy with fenofibrate plus UDCA i...

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Published inThe open cardiovascular medicine journal Vol. 4; no. 1; pp. 120 - 126
Main Authors Liberopoulos, E N, Florentin, M, Elisaf, M S, Mikhailidis, D P, Tsianos, E
Format Journal Article
LanguageEnglish
Published United Arab Emirates Bentham Open 28.04.2010
Subjects
liver enzymes
Fibrates
ursodeoxycholic acid
dyslipidemia
primary biliary cirrhosis
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Summary:Most patients with primary biliary cirrhosis (PBC) are treated with ursodeoxycholic acid (UDCA); however, some do not respond fully. PBC is also associated with dyslipidemia, but a link with vascular risk has not been confirmed. In this study we compared UDCA monotherapy with fenofibrate plus UDCA in PBC patients with incomplete biochemical response to UDCA monotherapy for >/= 8 months. Ten patients (57.2+/-13.3 years old) with PBC and persistent elevations of liver enzymes after treatment with UDCA (600 mg/day) were randomized to continue UDCA (4 patients) or to receive micronized fenofibrate (200 mg/day) plus UDCA (6 patients) for 8 weeks. Significant reductions in total cholesterol, triglycerides and non-high density lipoprotein cholesterol were observed in the combination treatment group. The serum activities of alkaline phosphatase, gamma-glutamyl transpeptidase and alanine aminotranferase also decreased in this group compared with baseline (-32.6%; p=0.012, -44%; p=0.031 and -16.9%; p=0.029, respectively). In contrast, no significant alterations in liver enzymes or lipid profile were observed in patients who continued UDCA monotherapy. The changes in the lipid and enzyme variables differed significantly (p<0.03) between the 2 groups. Fenofibrate was well tolerated. The administration of fenofibrate plus UDCA seems to be safe and may improve lipid and liver indices in patients with PBC who do not respond fully to UDCA monotherapy. Whether the improved lipid profile translates into a decreased risk of vascular events remains to be established.
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ISSN:1874-1924
1874-1924
DOI:10.2174/1874192401004010120