Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis
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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 |
- 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 ]
- 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 |
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| Austria | |
| Department of Internal Medicine, Medical University of Graz | |
| Graz, Austria, 8036 | |
| 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, Biliary Hypercholesterolemia Liver Cirrhosis Fibrosis Cholestasis, Intrahepatic Cholestasis Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Liver Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Pathologic Processes Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013