Cardiology Division, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
Atherosclerosis. 2012 Mar;221(1):169-75. doi: 10.1016/j.atherosclerosis.2011.12.042. Epub 2012 Jan 5.
The aim of this study is to compare the non-lipid effects of rosuvastatin-fenofibrate combination therapy with rosuvastatin monotherapy in high-risk Asian patients with mixed hyperlipidemia.
A total of 236 patients were initially screened. After six weeks of diet and life style changes, 180 of these patients were randomly assigned to receive one of two regimens: rosuvastatin 10 mg plus fenofibrate 160 mg or rosuvastatin 10 mg. The primary outcome variables were the incidences of muscle or liver enzyme elevation. The patients were followed for 24 weeks during drug treatment and for an additional four weeks after drug discontinuation.
The rates of the primary outcome variables were similar between the two groups (2.8% and 3.9% in the combination and the rosuvastatin groups, respectively, p=1.00). The combination group had more, but not significantly, common treatment-related adverse events (AEs) (13.3% and 5.6%, respectively) and drug discontinuation due to AEs (10.0% and 3.3%, respectively) than the rosouvastatin group. Combination therapy was associated with higher elevations in homocysteine, blood urea nitrogen, and serum creatinine, whereas elevation in alanine aminotransferase was greater in the rosuvastatin group. Leukocyte count and hemoglobin level decreased to a greater extent in the combination group. The combination group showed greater reductions in TG and elevation in HDL-cholesterol.
In our study population, the rosuvastatin-fenofibrate combination resulted in comparable incidences of myo- or hepatotoxicity as rosuvastatin monotherapy. However, this combination may need to be used with caution in individuals with underlying pathologies such as renal dysfunction (NCT01414803).
本研究旨在比较瑞舒伐他汀-非诺贝特联合治疗与瑞舒伐他汀单药治疗高危亚洲混合性高脂血症患者的非脂质作用。
共筛选了 236 例患者。经过 6 周的饮食和生活方式改变后，其中 180 例患者被随机分为两组：瑞舒伐他汀 10mg 加非诺贝特 160mg 或瑞舒伐他汀 10mg。主要观察指标为肌肉或肝酶升高的发生率。在药物治疗期间随访 24 周，并在停药后再随访 4 周。
两组主要观察指标的发生率相似（联合组和瑞舒伐他汀组分别为 2.8%和 3.9%，p=1.00）。联合组更常见但无统计学意义的治疗相关不良事件（AE）（分别为 13.3%和 5.6%）和因 AE 停药（分别为 10.0%和 3.3%），但均高于瑞舒伐他汀组。联合治疗组同型半胱氨酸、血尿素氮和血清肌酐升高更明显，而瑞舒伐他汀组丙氨酸氨基转移酶升高更明显。白细胞计数和血红蛋白水平在联合组下降更明显。联合组 TG 降低和 HDL-cholesterol 升高更明显。
在我们的研究人群中，瑞舒伐他汀-非诺贝特联合治疗与瑞舒伐他汀单药治疗的肌毒性或肝毒性发生率相当。然而，对于肾功能不全等基础疾病患者，这种联合治疗可能需要谨慎使用（NCT01414803）。
