Safety and efficacy of long-term treatment with atorvastatin in patients with primary biliary cirrhosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002160-28-AT

Enrollment

Registered

2005-08-19

Start date

2005-09-23

Completion date

Unknown

Last updated

2013-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reduction of cardiovascular risk may become key for the management of PBC. Therefore information on safety and efficacy (lipid-lowering effects) of statins in chronic cholestatic disorders is essential. Moreover, the study will answer the open question whether long-term treatment with statins may have potential beneficial effects on the course of PBC.

Interventions

Trade Name: Sortis Product Name: Sortis 10 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Atorvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration numb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria (PBC): LDL-cholesterol >= 130 mg/dl Primary biliary cirrhosis (AMA positive or biopsy proven) Male or female gender Age 18-70 years Normal kidney function Inclusion criteria (non-PBC): LDL-cholesterol >= 130 mg/dl matched for age, gender, glucose metabolism and vascular disease manifestations Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 factors. Statins may reduce serum cholesterol levels and cardiovascular risk in PBC patients although this remains to be determined. Statins are generally well tolerated by patients with nonalcoholic fatty liver disease (NAFLD) and are not associated with an increased risk of hepatotoxicity. In regard to cholestatic liver diseases only limited data on safety of statins are available. Atorvastatin did not statistically increase liver enzymes in PBC patients in a recent pilot study at the Medical University Graz. However, data on long-term treatment with atorvastatin in these patients are not yet available.;Secondary Objective: Moreover, we aim to test the hypotheses that the cholesterol-lowering effect of atorvastatin and the safety concerning hepatotoxicity in PBC patients does not differ from non-cholestatic, hypercholesterolemic patients.;Primary end point(s): LDL-cholesterol (LDL-C)	—

Measure

Time frame

Main Objective: 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 factors. Statins may reduce serum cholesterol levels and cardiovascular risk in PBC patients although this remains to be determined. Statins are generally well tolerated by patients with nonalcoholic fatty liver disease (NAFLD) and are not associated with an increased risk of hepatotoxicity. In regard to cholestatic liver diseases only limited data on safety of statins are available. Atorvastatin did not statistically increase liver enzymes in PBC patients in a recent pilot study at the Medical University Graz. However, data on long-term treatment with atorvastatin in these patients are not yet available.;Secondary Objective: Moreover, we aim to test the hypotheses that the cholesterol-lowering effect of atorvastatin and the safety concerning hepatotoxicity in PBC patients does not differ from non-cholestatic, hypercholesterolemic patients.;Primary end point(s): LDL-cholesterol (LDL-C)

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026