Outpatient Department, National Health Centre, Budapest, Hungary.
Med Sci Monit. 2009 Dec;15(12):MS6-11.
Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases all over the world. In patients with a high cardiovascular risk the decrease of cholesterol level is especially important. The primary goal of this study is to observe the safety and efficacy of combined ezetimibe / simvastatin treatment and simvastatin monotherapy in patients with NAFLD and high cardiovascular risk disease. The secondary goal of this investigation was to compare the safety and efficacy of combined ezetimibe / simvastatin treatment with simvastatin monotherapy.
MATERIAL/METHODS: The data of 45 patients with NAFLD associated with type2 diabetes and metabolic syndrome were examined. They were diagnosed and treated in Budaörs Health Centre between 2005 and 2008. Twenty-six of the patients were treated with simvastatin (20 mg/day) and 19 individuals were given ezetimibe / simvastatin therapy (10/10 mg). The safety (aspartate-aminotransferase-AST-, alanine-aminotransferase-ALT- and creatine kinase-CK-values) and efficacy (cholesterol, low density lipoprotein-LDL- cholesterol, high density lipoprotein-HDL- cholesterol and triglyceride) of the treatments had been studied for six months of the treatment period.
Ezetimibe/simvastatin treatment resulted in a significant decrease in ALT (63.78+/-5.12 vs 32.57+/-3.92 U/L; p<0.0001) and AST (50.79+/-3.66 vs 23.68+/-3.42 U/L; p<0.0001). Simvastatin monotherapy also yielded significant decrease in ALT (66.58+/-6.13 vs 29.46+/-4.07 U/L; p<0.0001) and AST (59.61+/-5.97 vs 24.00+/-3.87 U/L; p<0.0001). Comparing the two treatment groups, simvastatin monotherapy reduced ALT (37.11+/-8.01 vs 31.21+/-7.08 U/L; p<0.0112) and AST (35.61+/-7.20 vs 27.10+/-5.22 U/L; p<or=0.0001) to a significantly larger extent related to combined ezetimibe/simvastatin therapy, while there was no substantial difference between the two treatments concerning cholesterol decrease, triglyceride reduction and HDL cholesterol elevation levels. LDL cholesterol levels decrease (62.64+/-17.01 vs 77.72+/-15.08 mg/dl; p=0.0063) to a significantly larger extent in connection with ezetimibe/simvastatin therapy.
These results showed that both the combined ezetimibe/simvastatin treatment and the simvastatin monotherapy proved to be effective and safe in patients with NAFLD and in cases of high cardiovascular risk.
非酒精性脂肪性肝病（NAFLD）是全世界最常见的慢性肝病之一。在心血管风险较高的患者中，降低胆固醇水平尤为重要。本研究的主要目的是观察联合依折麦布/辛伐他汀治疗与辛伐他汀单药治疗在伴有高心血管风险疾病的 NAFLD 患者中的安全性和疗效。本研究的次要目的是比较联合依折麦布/辛伐他汀治疗与辛伐他汀单药治疗的安全性和疗效。
材料/方法：检查了 2005 年至 2008 年间在布达佩斯健康中心诊断和治疗的 45 例伴有 2 型糖尿病和代谢综合征的 NAFLD 患者的数据。其中 26 例患者接受辛伐他汀（20mg/天）治疗，19 例患者给予依折麦布/辛伐他汀治疗（10/10mg）。在治疗期间的六个月内，研究了治疗的安全性（天冬氨酸转氨酶-AST-、丙氨酸转氨酶-ALT-和肌酸激酶-CK 值）和疗效（胆固醇、低密度脂蛋白胆固醇、高密度脂蛋白胆固醇和甘油三酯）。
依折麦布/辛伐他汀治疗可显著降低 ALT（63.78+/-5.12 与 32.57+/-3.92 U/L；p<0.0001）和 AST（50.79+/-3.66 与 23.68+/-3.42 U/L；p<0.0001）。辛伐他汀单药治疗也可显著降低 ALT（66.58+/-6.13 与 29.46+/-4.07 U/L；p<0.0001）和 AST（59.61+/-5.97 与 24.00+/-3.87 U/L；p<0.0001）。比较两种治疗组，辛伐他汀单药治疗可更显著地降低 ALT（37.11+/-8.01 与 31.21+/-7.08 U/L；p<0.0112）和 AST（35.61+/-7.20 与 27.10+/-5.22 U/L；p<or=0.0001），而在胆固醇降低、甘油三酯减少和 HDL 胆固醇升高方面，两种治疗之间没有实质性差异。LDL 胆固醇水平（62.64+/-17.01 与 77.72+/-15.08mg/dl；p=0.0063）在联合依折麦布/辛伐他汀治疗中显著降低。
这些结果表明，联合依折麦布/辛伐他汀治疗和辛伐他汀单药治疗在伴有 NAFLD 和高心血管风险的患者中均有效且安全。
