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Fenofibrate in primary biliary cirrhosis: a pilot study.

E N Liberopoulos¹, M Florentin, M S Elisaf

¹Department of Internal Medicine, Medical School, University of Ioannina, Ioannina, 45110, Greece.

The Open Cardiovascular Medicine Journal

|June 18, 2010

Summary

Adding fenofibrate to ursodeoxycholic acid (UDCA) improved lipid profiles and liver enzymes in primary biliary cirrhosis (PBC) patients with incomplete UDCA response. This combination therapy appears safe and effective for managing PBC symptoms.

Keywords:

Fibrates dyslipidemia.liver enzymes primary biliary cirrhosis ursodeoxycholic acid

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Area of Science:

Hepatology
Clinical Pharmacology
Cardiovascular Risk Management

Background:

Primary biliary cirrhosis (PBC) is often treated with ursodeoxycholic acid (UDCA), but treatment response can be incomplete.
PBC is associated with dyslipidemia, yet its link to vascular risk is not fully established.

Purpose of the Study:

To evaluate the efficacy and safety of adding fenofibrate to UDCA in PBC patients with an incomplete biochemical response to UDCA monotherapy.

Main Methods:

A randomized study compared UDCA monotherapy with fenofibrate plus UDCA in PBC patients with elevated liver enzymes after at least 8 months of UDCA treatment.
Ten patients were randomized to continue UDCA or receive micronized fenofibrate (200 mg/day) plus UDCA (600 mg/day) for 8 weeks.

Main Results:

The combination group showed significant reductions in total cholesterol, triglycerides, and non-high-density lipoprotein cholesterol.
Serum activities of alkaline phosphatase, gamma-glutamyl transpeptidase, and alanine aminotransferase decreased significantly in the combination group compared to baseline.
No significant changes in liver enzymes or lipid profiles were observed in the UDCA monotherapy group.

Conclusions:

Fenofibrate combined with UDCA appears safe and improves lipid and liver indices in PBC patients with suboptimal UDCA response.
Further research is needed to determine if the observed improvements in lipid profiles reduce the risk of vascular events.