Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis

Primary biliary cirrhosis (PBC) is often associated with abnormalities in serum lipids. Hypercholesterolemia is an established risk factor for cardiovascular morbidity and mortality. Since many PBC patients have a very slow progression of their underlying liver disease cardiovascular risk factors may become more relevant as prognostic facors. Whether statins lower serum cholesterol levels and reduce the cardiovascular risk in PBC patients remains to be determined. Statins are generally well tolerated and are not associated with an increased risk of hepatotoxicity in patients with nonalcoholic fatty liver disease (NAFLD). However only limited data on safety on statins in chronic cholestatic liver diseases are available. In a recent pilot study at the Medical University of Graz atorvastatin did not statistically increase liver enzymes in PBC patients. However, data on long-term treatment with atorvastatin in these patients are not yet available. Moreover, long-term treatment with statins may have potential beneficial immunomodulatory effects on the disease course of PBC in analogy to other immune-mediated disorders such as rheumatoid arthritis and multiple sclerosis.

Inclusion criteria

• LDL-cholesterol > 130 mg/dl
• Primary biliary cirrhosis (AMA positive or biopsy proven)
• Male or female gender
• Age 18-70 years
• Normal kidney function

Exclusion criteria

• Primary biliary cirrhosis Stage III-IV (Ludwig Score)
• Liver cirrhosis
• Decompensated liver disease ( > Child-Pugh class B, ascites, esophageal varices)
• ALT or AST > 2x ULN
• Pregnancy or breastfeeding
• Premenopausal women without certain contraception
• Known hypersensitivity to HMG-CoA reductase inhibitors
• Current treatment with lipid-lowering agents other than atorvastatin; immunosuppressants, macrolides