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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00844402
First received: February 13, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Primary Biliary Cirrhosis
Hypercholesterolemia
Drug: Atorvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Low-density lipoprotein cholesterol (LDL-C) [ Time Frame: week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intima-media thickness of the common carotid artery (IMT), vascular wall stiffness (stiffness index SI), flow-mediated dilation of the brachial artery (FMD) [ Time Frame: week 0, 48 ] [ Designated as safety issue: No ]
  • Total cholesterol, triglycerides, VLDL-C, HDL-C, lipid profile, hs-CRP, AP, GGT, bilirubin, bile acids, immunoglobins [ Time Frame: week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60 ] [ Designated as safety issue: No ]
  • AST, ALT, CK, PZ, AT, albumin, creatinine, blood cell count [ Time Frame: week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60 ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: January 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin
Atorvastatin 10 mg per day for 48 weeks
Drug: Atorvastatin
oral, 10 mg, daily, 48 weeks
Other Name: Sortis10 mg, 1-21927, C10AA05

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844402

Locations
Austria
Department of Internal Medicine, Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Michael Trauner, M.D. Medical University of Graz, Department of Internal Medicine
  More Information

No publications provided by Medical University of Graz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Michael Trauner, Medical University of Graz, Department of Internal Medicine
ClinicalTrials.gov Identifier: NCT00844402     History of Changes
Other Study ID Numbers: MT_PBC-2
Study First Received: February 13, 2009
Last Updated: February 13, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Graz:
Cholestasis
Atherosclerosis
Statins
Vascular function

Additional relevant MeSH terms:
Liver Cirrhosis
Hypercholesterolemia
Liver Cirrhosis, Biliary
Liver Diseases
Digestive System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014