Davidson Michael H, Palmisano Joanne, Wilson Helene, Liss Charles, Dicklin Mary R
Radiant Research-Chicago, Chicago, Illinois 60610, USA.
Clin Ther. 2003 Nov;25(11):2738-53. doi: 10.1016/s0149-2918(03)80330-2.
The available statin drugs have similar pharmacodynamic properties but are not equal in low-density lipoprotein cholesterol (LDL-C)-lowering efficacy.
The aim of this study was to compare the effects of lovastatin and fluvastatin in lowering LDL-C.
This was a prospective, randomized, double-blind study of patients aged >20 years with primary hypercholesterolemia conducted at 44 clinical sites across the United States. After a 6-week National Cholesterol Education Program (NCEP) Step I diet lead-in period in patients taking lipid-lowering drugs at screening, patients were randomized to receive lovastatin 10, 20, or 40 mg/d or fluvastatin 20 or 40 mg/d (the doses available at the time the study was conducted) for 6 weeks. Patients not taking lipid-lowering drugs at screening and who had been following the Step I diet for at least 6 weeks proceeded to the treatment phase. All patients received instruction for a Step I diet, which they followed throughout the treatment phase. After the treatment period, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides were measured, and TC:HDL-C and LDL-C:HDL-C ratios were calculated.
A total of 838 patients (476 men, 362 women; mean [SD] age, 59 [12] years) were included in the study. Lovastatin 20 and 40 mg/d significantly reduced mean LDL-C compared with the same dosages of fluvastatin. TC and the LDL-C:HDL-C ratio decreased more with lovastatin than with fluvastatin at a given dose level. Approximately 50% of patients treated with lovastatin 20 and 40 mg/d compared with approximately 25% treated with fluvastatin 20 and 40 mg/d reached NCEP Adult Treatment Panel II LDL-C goals.
In this small study population of patients with primary hypercholesterolemia taking lipid-lowering drugs, short-term (6-week) treatment with lovastatin was more efficacious than fluvastatin in lowering cholesterol levels and reaching LDL-C treatment goals.
现有的他汀类药物具有相似的药效学特性，但在降低低密度脂蛋白胆固醇（LDL-C）方面的疗效并不相同。
本研究旨在比较洛伐他汀和氟伐他汀降低LDL-C的效果。
这是一项在美国44个临床地点对年龄大于20岁的原发性高胆固醇血症患者进行的前瞻性、随机、双盲研究。在筛查时服用降脂药物的患者经过6周的美国国家胆固醇教育计划（NCEP）第一步饮食导入期后，患者被随机分配接受洛伐他汀10、20或40mg/d或氟伐他汀20或40mg/d（研究进行时可用的剂量），为期6周。筛查时未服用降脂药物且遵循第一步饮食至少6周的患者进入治疗阶段。所有患者均接受第一步饮食指导，并在整个治疗阶段遵循该饮食。治疗期结束后，测量总胆固醇（TC）、高密度脂蛋白胆固醇（HDL-C）、LDL-C和甘油三酯，并计算TC:HDL-C和LDL-C:HDL-C比值。
共有838名患者（476名男性，362名女性；平均[标准差]年龄，59[12]岁）纳入研究。与相同剂量的氟伐他汀相比，洛伐他汀20和40mg/d显著降低了平均LDL-C。在给定剂量水平下，洛伐他汀使TC和LDL-C:HDL-C比值的下降幅度大于氟伐他汀。与接受氟伐他汀20和40mg/d治疗的约25%患者相比，接受洛伐他汀20和40mg/d治疗的约50%患者达到了NCEP成人治疗小组II的LDL-C目标。
在这个服用降脂药物的原发性高胆固醇血症患者的小研究人群中，洛伐他汀短期（6周）治疗在降低胆固醇水平和达到LDL-C治疗目标方面比氟伐他汀更有效。
