Chatley P, Badyal D K, Calton R, Khosla P P
Department of Pharmacology, Christian Medical College and Hospital, Ludhiana, India.
Methods Find Exp Clin Pharmacol. 2007 Apr;29(3):217-21. doi: 10.1358/mf.2007.29.3.1075363.
Mixed hyperlipidemia is a major cause of coronary artery disease. Monotherapy with statins is considered the gold standard for treatment of mixed hyperlipidemia. But greater benefit may be expected by combination therapy. Combination may allow lower doses of statins and less adverse effects. Hence, this preliminary study was designed to evaluate the efficacy and safety of low-dose atorvastatin in combination with fenofibrate in patients with mixed hyperlipidemia. Ninety patients were assigned into three groups and received atorvastatin (10-40 mg/day) or fenofibrate (160-200 mg/day) or combination of low-dose atorvastatin (5 mg/day) and fenofibrate (160 mg/day). There was a significant decrease in low-density lipoprotein (LDL), triglycerides (TG) and total cholesterol (TC), and a significant increase in high-density lipoprotein (HDL) in all the groups at the end of therapy. Combination therapy produced maximum decrease in LDL, TG and TC, and maximum increase in HDL when compared with monotherapies. No significant difference was reported in safety profile between the two groups. To conclude, the results suggest that combination therapy with low-dose atorvastatin and fenofibrate is more efficacious, with no increase in adverse effects when compared with monotherapies with individual drugs for mixed hyperlipidemia. The results are preliminary and suggestive only, as the study was open and nonrandomized.
混合型高脂血症是冠状动脉疾病的主要病因。他汀类药物单药治疗被认为是混合型高脂血症治疗的金标准。但联合治疗可能会带来更大益处。联合治疗可使他汀类药物剂量更低且不良反应更少。因此,本初步研究旨在评估低剂量阿托伐他汀联合非诺贝特治疗混合型高脂血症患者的疗效和安全性。90例患者被分为三组,分别接受阿托伐他汀(10 - 40毫克/天)或非诺贝特(160 - 200毫克/天)或低剂量阿托伐他汀(5毫克/天)与非诺贝特(160毫克/天)联合治疗。治疗结束时,所有组的低密度脂蛋白(LDL)、甘油三酯(TG)和总胆固醇(TC)均显著降低,高密度脂蛋白(HDL)显著升高。与单药治疗相比,联合治疗使LDL、TG和TC降低幅度最大,HDL升高幅度最大。两组在安全性方面未报告有显著差异。总之,结果表明,与混合型高脂血症的单药治疗相比,低剂量阿托伐他汀与非诺贝特联合治疗更有效,且不良反应未增加。由于该研究为开放性且非随机的,所以结果仅为初步且具有提示性。