Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Low-density lipoprotein cholesterol (LDL-C)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LDL-cholesterol > 130 mg/dl
- •Primary biliary cirrhosis (AMA positive or biopsy proven)
- •Male or female gender
- •Age 18-70 years
- •Normal kidney function
排除标准
- •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
研究组 & 干预措施
Atorvastatin
Atorvastatin 10 mg per day for 48 weeks
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Low-density lipoprotein cholesterol (LDL-C)
时间窗: week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60
次要结局
- Intima-media thickness of the common carotid artery (IMT), vascular wall stiffness (stiffness index SI), flow-mediated dilation of the brachial artery (FMD)(week 0, 48)
- Total cholesterol, triglycerides, VLDL-C, HDL-C, lipid profile, hs-CRP, AP, GGT, bilirubin, bile acids, immunoglobins(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(week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60)