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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

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