Arterial Imaging Outcomes and Cardiovascular Risk Factors in Recently Menopausal Women A Randomized Trial
Arterial Imaging Outcomes and Cardiovascular Risk Factors in Recently Menopausal Women A Randomized Trial
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DOI：
10.7326/m14-0353
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发表时间：
2014-08-19
影响因子：
39.2
通讯作者：
Hodis, Howard N.
中科院分区：
文献类型：
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作者：
Harman, S. Mitchell;Black, Dennis M.;Hodis, Howard N.
背景资料：绝经期激素治疗（MHT）是否能预防心血管疾病（CVD）仍不清楚。目的：评估绝经早期开始MHT后动脉粥样硬化进展和CVD危险因素。设计：随机对照试验。（临床试验政府网站：NCT 00154180）设置：9个美国学术中心。参与者：年龄42至58岁的健康绝经期妇女，从末次月经起6至36个月，既往无CVD事件，冠状动脉钙（CAC）评分低于50 Agatston单位，且至少90天未接受雌激素或降脂治疗。干预：口服共轭马雌激素（o-CEE），0.45毫克/天，或经皮17 β-雌二醇（t-E-2），50微克/天，每200毫克口服孕酮每月12天，或安慰剂48 months.Measurements：主要终点是颈动脉内膜中层厚度（CIMT）的年度变化。次要终点包括CVD风险标志物的变化。结果：727名随机分配的妇女中，89.3%至少有1个后续CIMT和79.8%的CIMT在48个月。各组间平均CIMT增加0.007 mm/y相似。CAC分数增加的参与者百分比在各组之间没有显著差异。o-CEE或t-E-2未观察到血压变化。低密度和高密度脂蛋白胆固醇水平改善，C-反应蛋白和性激素结合球蛋白水平增加，但不增加白细胞介素-6。胰岛素抵抗随着t-E-2的增加而降低。严重的不良事件并没有不同的治疗。限制：权力比较临床事件是不够的。结论：四年的早期MHT并没有影响动脉粥样硬化的进展，尽管改善了一些标志物的CVD风险。
Background: Whether menopausal hormone therapy (MHT) protects against cardiovascular disease (CVD) remains unclear.Objective: To assess atherosclerosis progression and CVD risk factors after MHT initiated in early menopause.Design: Randomized, controlled trial. (ClinicalTrials.gov: NCT00154180)Setting: Nine U.S. academic centers.Participants: Healthy menopausal women aged 42 to 58 years between 6 and 36 months from last menses without prior CVD events who had a coronary artery calcium (CAC) score less than 50 Agatston units and had not received estrogen or lipid-lowering therapy for at least 90 days.Intervention: Oral conjugated equine estrogens (o-CEE), 0.45 mg/d, or transdermal 17 beta-estradiol (t-E-2), 50 mcg/d, each with 200 mg of oral progesterone for 12 days per month, or placebo for 48 months.Measurements: Primary end point was annual change in carotid artery intima-media thickness (CIMT). Secondary end points included changes in markers of CVD risk.Results: Of 727 randomly assigned women, 89.3% had at least 1 follow-up CIMT and 79.8% had CIMT at 48 months. Mean CIMT increases of 0.007 mm/y were similar across groups. The percentages of participants in whom CAC score increased did not differ significantly across groups. No changes in blood pressure were observed with o-CEE or t-E-2. Low-and high-density lipoprotein cholesterol levels improved and levels of C-reactive protein and sex hormone-binding globulin but not interleukin-6 increased with o-CEE. Insulin resistance decreased with t-E-2. Serious adverse events did not differ by treatment.Limitation: Power to compare clinical events was insufficient.Conclusion: Four years of early MHT did not affect progression of atherosclerosis despite improving some markers of CVD risk.