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

Medical University of Graz

Status and phase

Completed

Phase 3

Conditions

Hypercholesterolemia

Primary Biliary Cirrhosis

Treatments

Drug: Atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00844402

MT_PBC-2

Details and patient eligibility

About

Primary biliary cirrhosis (PBC) is frequently associated with hypercholesterolemia and possibly with an increased cardiovascular morbidity and mortality. Statins lower serum cholesterol levels and may thus improve the cardiovascular risk in PBC patients. The aim of our study therefore was to prospectively examine the efficacy of low-dose atorvastatin on indicators of cardiovascular risk such as dyslipidemia and vascular function as well as safety in patients with PBC.

Full description

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.

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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