Bakker-Arkema R G, Davidson M H, Goldstein R J, Davignon J, Isaacsohn J L, Weiss S R, Keilson L M, Brown W V, Miller V T, Shurzinske L J, Black D M
Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Co, Ann Arbor, Mich 48105-1047, USA.
JAMA. 1996 Jan 10;275(2):128-33.
To assess the lipid-lowering effect of atorvastatin (a new 3-hydroxy-3-methylglutaryl coenzyme A [HMG-CoA] reductase inhibitor) on levels of serum triglycerides and other lipoprotein fractions in patients with primary hypertriglyceridemia, determine if atorvastatin causes a redistribution of triglycerides in various lipoprotein fractions, and assess its safety by reporting adverse events and clinical laboratory measurements.
Randomized double-blind, placebo-controlled, parallel-group, multicenter trial.
Community- and university-based research centers.
A total of 56 patients (aged 26 to 74 years) with a mean baseline triglyceride level of 6.80 mmol/L (603.3 mg/dL) and a mean baseline low-density lipoprotein cholesterol (LDL-C) level of 3.07 mmol/L (118.7 mg/dL).
Cholesterol-lowering diet (National Institutes of Health National Cholesterol Education Program Step I Diet) and either 5 mg, 20 mg, or 80 mg of atorvastatin, or placebo.
Percent change from baseline in total triglycerides for three dose levels of atorvastatin compared with placebo.
Mean reductions in total triglycerides between 5 mg, 20 mg, and 80 mg of atorvastatin and placebo after 4 weeks of treatment were -26.5%, -32.4%, -45.8%, and -8.9%, respectively. Mean reductions in LDL-C were -16.7%, -33.2%, -41.4%, and -1.4%, respectively, and very low-density lipoprotein cholesterol (VLDL-C) were -34.3%, -45.9%, -57.7%, and -5.5%, respectively. Similar mean changes in total apolipoprotein B (apo B) (-16.9%, -32.8%, -41.7%, and +1.0%), apo B in LDL (-14.8%, -29.8%, -42.0%, and -3.1%), and apo B in VLDL (-23.8%, -35.8%, -34.4%, and +11.7%) were observed. In addition, comparable mean changes in LDL triglycerides (-22.5%, -30.7%, -39.9%, and +3.9%) and VLDL triglycerides (-28.1%, -34.0%, -47.3%, and -10.8%) were seen.
In atorvastatin treatment groups, total serum triglyceride levels decreased in a dose-dependent manner, reductions in the 20-mg and 80-mg groups were statistically significant (P < .05) compared with placebo. Atorvastatin did not cause a redistribution of triglycerides but consistently lowered triglycerides in all lipoprotein fractions. Atorvastatin was well tolerated.
评估阿托伐他汀（一种新型3-羟基-3-甲基戊二酰辅酶A [HMG-CoA]还原酶抑制剂）对原发性高甘油三酯血症患者血清甘油三酯水平及其他脂蛋白组分的降脂作用，确定阿托伐他汀是否会导致甘油三酯在不同脂蛋白组分中的重新分布，并通过报告不良事件和临床实验室检测评估其安全性。
随机双盲、安慰剂对照、平行组、多中心试验。
社区及大学研究中心。
共56例患者（年龄26至74岁），平均基线甘油三酯水平为6.80 mmol/L（603.3 mg/dL），平均基线低密度脂蛋白胆固醇（LDL-C）水平为3.07 mmol/L（118.7 mg/dL）。
降胆固醇饮食（美国国立卫生研究院国家胆固醇教育计划第一步饮食），以及5 mg、20 mg或80 mg阿托伐他汀，或安慰剂。
与安慰剂相比，阿托伐他汀三个剂量水平的总甘油三酯较基线的变化百分比。
治疗4周后，5 mg、20 mg和80 mg阿托伐他汀组与安慰剂组相比，总甘油三酯的平均降低幅度分别为-26.5%、-32.4%、-45.8%和-8.9%。LDL-C的平均降低幅度分别为-16.7%、-33.2%、-41.4%和-1.4%，极低密度脂蛋白胆固醇（VLDL-C）的平均降低幅度分别为-34.3%、-45.9%、-57.7%和-5.5%。观察到总载脂蛋白B（apo B）（-16.9%、-32.8%、-41.7%和+1.0%）、LDL中的apo B（-14.8%、-29.8%、-42.0%和-3.1%）以及VLDL中的apo B（-23.8%、-35.8%、-34.4%和+11.7%）有类似的平均变化。此外，LDL甘油三酯（-22.5%、-30.7%、-39.9%和+3.9%）和VLDL甘油三酯（-28.1%、-34.0%、-47.3%和-10.8%）也有相当的平均变化。
在阿托伐他汀治疗组中，血清总甘油三酯水平呈剂量依赖性下降，20 mg和80 mg组与安慰剂相比降低具有统计学意义（P <.05）。阿托伐他汀不会导致甘油三酯重新分布，而是持续降低所有脂蛋白组分中的甘油三酯。阿托伐他汀耐受性良好。
