来自选择性雌激素、绝经与治疗反应（SMART）试验的共轭雌激素/巴多昔芬对绝经后女性脂质参数影响的汇总分析。
A Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Lipid Parameters in Postmenopausal Women From the Selective Estrogens, Menopause, and Response to Therapy (SMART) Trials.
作者信息
Stevenson John C, Chines Arkadi, Pan Kaijie, Ryan Kelly A, Mirkin Sebastian
出版信息
J Clin Endocrinol Metab. 2015 Jun;100(6):2329-38. doi: 10.1210/jc.2014-2649. Epub 2015 Apr 20.
CONTEXT
Menopausal lipid profile changes may increase cardiovascular risk. The effects of conjugated estrogens (CE)/bazedoxifene (BZA), an approved menopausal therapy, on lipids have not been fully characterized.
OBJECTIVE
The purpose of this study was to determine the effects of CE/BZA on lipids in the Selective estrogens, Menopause, And Response to Therapy (SMART) trials for ≥ 1 year.
DESIGN
This was a pooled analysis of 3 randomized, double-blind, placebo (PBO)-controlled phase 3 trials (SMART-1, -4, and -5).
SETTING
The study was conducted in North America, Europe, Asia-Pacific Region, and Latin America.
PARTICIPANTS
Participants were nonhysterectomized postmenopausal women aged 40 to 75 years, not taking lipid-lowering medications (N = 2796).
INTERVENTIONS
Treatments were CE 0.45 mg/BZA 20 mg, CE 0.625 mg/BZA 20 mg, and PBO.
MAIN OUTCOME MEASURES
The adjusted mean percentage changes from baseline in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides, and the LDL-C/HDL-C ratio at 12 and 24 months were measured.
RESULTS
At 12 months, CE 0.45 mg/BZA 20 mg and CE 0.625 mg/BZA 20 mg produced significant (P < .001) improvements vs PBO in TC (-4.20% and -4.37% vs -0.88%), LDL-C (-9.33% and -10.78% vs -1.08%), HDL-C (4.59% and 6.21% vs 1.30%), and the LDL-C/HDL-C ratio (-11.59% and -14.00% vs -0.84%). Triglycerides were significantly (P < .001) increased from baseline with both doses vs PBO (15.13% and 15.74% vs 4.43%). Similar trends (all P < .001) were seen at 24 months when SMART-1 and SMART-4 were pooled (TC: -3.25% and -3.13% vs 0.95%; LDL-C: -7.47% and -8.08% vs 2.95%; HDL-C: 5.91% and 7.19% vs 1.72%; triglycerides: 18.87% and 18.82% vs 6.49%; and the LDL-C/HDL-C ratio: -10.05% and -12.82% vs 2.56%).
CONCLUSIONS
CE/BZA was associated with mostly favorable changes in lipid parameters for up to 2 years in nonhysterectomized postmenopausal women.
背景
更年期血脂谱变化可能会增加心血管疾病风险。已获批的更年期治疗药物共轭雌激素（CE）/巴多昔芬（BZA）对血脂的影响尚未完全明确。
目的
本研究的目的是在选择性雌激素、更年期与治疗反应（SMART）试验中，确定CE/BZA治疗≥1年对血脂的影响。
设计
这是一项对3项随机、双盲、安慰剂（PBO）对照的3期试验（SMART-1、-4和-5）的汇总分析。
地点
该研究在北美、欧洲、亚太地区和拉丁美洲进行。
参与者
参与者为40至75岁未行子宫切除术的绝经后女性，未服用降脂药物（N = 2796）。
干预措施
治疗药物为CE 0.45 mg/BZA 20 mg、CE 0.625 mg/BZA 20 mg和PBO。
主要观察指标
测量12个月和24个月时，总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、高密度脂蛋白胆固醇（HDL-C）、甘油三酯以及LDL-C/HDL-C比值相对于基线的调整后平均百分比变化。
结果
在12个月时，与PBO相比，CE 0.45 mg/BZA 20 mg和CE 0.625 mg/BZA 20 mg在TC（分别为-4.20%和-4.37%，PBO为-0.88%）、LDL-C（分别为-9.33%和-10.78%，PBO为-1.08%）、HDL-C（分别为4.59%和6.21%，PBO为1.30%）以及LDL-C/HDL-C比值（分别为-11.59%和-14.00%，PBO为-0.84%）方面产生了显著改善（P <.001）。与PBO相比，两种剂量的药物均使甘油三酯从基线水平显著升高（P <.001）（分别为15.13%和15.74%，PBO为4.43%）。在24个月时，当汇总SMART-1和SMART-4的数据时，观察到了类似的趋势（所有P <.001）（TC：分别为-3.25%和-3.13%，PBO为0.95%；LDL-C：分别为-7.47%和-8.08%，PBO为2.95%；HDL-C：分别为5.91%和7.19%，PBO为1.72%；甘油三酯：分别为18.87%和18.82%，PBO为6.49%；LDL-C/HDL-C比值：分别为-10.05%和-12.82%，PBO为2.56%）。
结论
在未行子宫切除术的绝经后女性中，CE/BZA与长达2年的血脂参数大多有利变化相关。
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