Davidson M H, Testolin L M, Maki K C, von Duvillard S, Drennan K B
Chicago Center for Clinical Research, Ill, USA.
Arch Intern Med. 1997 Jun 9;157(11):1186-92.
To evaluate and compare the lipid-altering effects of conjugated estrogens and pravastatin, alone and in combination, in postmenopausal women with hypercholesterolemia.
This was a double-blind, randomized, placebo-controlled clinical trial with 4 parallel groups. Participants (N = 76) were randomly assigned to receive conjugated estrogens, 0.625 mg/d; pravastatin sodium, 20 mg/d; conjugated estrogens plus pravastatin; or a placebo for 16 weeks.
Primary end points were changes in serum lipid parameters. Among participants treated with conjugated estrogens, levels of non-high density lipoprotein cholesterol (non-HDL-C) (13.0%) and calculated low density lipoprotein cholesterol (LDL-C) (13.5%) decreased, while levels of HDL-C (22.5%) and triglycerides (4.2%) increased. Participants in the pravastatin group achieved reductions of 23.7% and 25.4% in non-HDL-C and calculated LDL-C levels, respectively. Levels of HDL-C increased slightly (3.7%) and triglycerides decreased by 12.1%. Among participants treated with a combination of conjugated estrogens plus pravastatin, the non-HDL-C (-25.2%) and calculated LDL-C (-28.7%) responses were similar to those of the pravastatin group, and the HDL-C response (21.2%) was similar to that observed in the conjugated estrogens group. Triglyceride levels remained similar to baseline (-0.9%) in the combined treatment group.
Administration of conjugated estrogens resulted in potentially antiatherogenic changes in levels of non-HDL-C, HDL-C, and calculated LDL-C. The HDL-C response to combined treatment was similar to that observed in women taking conjugated estrogens alone, while the non-HDL-C and LDL-C responses to combined treatment were similar to those produced by pravastatin therapy alone. These findings support the position of the National Cholesterol Education Program that estrogen replacement, with a progestin where indicated, should be given consideration as a therapeutic option for the management of hypercholesterolemia in postmenopausal women.
评估并比较共轭雌激素和普伐他汀单独及联合使用对绝经后高胆固醇血症女性的血脂改变作用。
这是一项双盲、随机、安慰剂对照的临床试验，设有4个平行组。参与者（N = 76）被随机分配接受以下治疗，为期16周：每日0.625毫克共轭雌激素；每日20毫克普伐他汀钠；共轭雌激素加普伐他汀；或安慰剂。
主要终点是血清脂质参数的变化。在接受共轭雌激素治疗的参与者中，非高密度脂蛋白胆固醇（non-HDL-C）水平（降低13.0%）和计算得出的低密度脂蛋白胆固醇（LDL-C）水平（降低13.5%）下降，而高密度脂蛋白胆固醇（HDL-C）水平（升高22.5%）和甘油三酯水平（升高4.2%）上升。普伐他汀组参与者的非HDL-C和计算得出的LDL-C水平分别降低了 23.7%和25.4%。HDL-C水平略有升高（3.7%），甘油三酯水平降低了12.1%。在接受共轭雌激素加普伐他汀联合治疗的参与者中，非HDL-C（降低25.2%）和计算得出的LDL-C（降低28.7%）的反应与普伐他汀组相似，HDL-C反应（升高21.2%）与共轭雌激素组观察到的相似。联合治疗组甘油三酯水平与基线水平相似（降低0.9%）。
服用共轭雌激素导致非HDL-C、HDL-C和计算得出的LDL-C水平发生潜在的抗动脉粥样硬化变化。联合治疗对HDL-C的反应与单独服用共轭雌激素的女性中观察到的相似，而联合治疗对非HDL-C和LDL-C的反应与单独使用普伐他汀治疗产生的反应相似。这些发现支持了国家胆固醇教育计划的立场，即对于绝经后女性高胆固醇血症的管理，在有指征时加用孕激素的雌激素替代疗法应被视为一种治疗选择。
