A Phase 3 interventional study of Atorvastatin in Primary Biliary Cirrhosis and Hypercholesterolemia, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-02-16.
Sponsored by Medical University of Graz · Phase 3, Interventional, and Treatment
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.
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 40 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Atorvastatin 10 mg per day for 48 weeks
Drug: Atorvastatin
oral, 10 mg, daily, 48 weeks
Also known as: Sortis10 mg, 1-21927, C10AA05
Low-density lipoprotein cholesterol (LDL-C)
Time frame: week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60
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
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
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
This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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Medical University of Graz