Using Basic Science to Design a Clinical Trial: Baseline Characteristics of Women Enrolled in the Kronos Early Estrogen Prevention Study (KEEPS)

被引：109

作者：

Miller, V. M. ^{[1
]}

Black, D. M. ^{[2
]}

Brinton, E. A. ^{[3
]}

Budoff, M. J. ^{[4
]}

Cedars, M. I. ^{[2
]}

Hodis, H. N. ^{[5
]}

Lobo, R. A. ^{[6
]}

Manson, J. E. ^{[7
]}

Merriam, G. R. ^{[8
]}

Naftolin, F. ^{[9
,10
]}

Santoro, N. ^{[9
]}

Taylor, H. S. ^{[11
]}

Harman, S. M. ^{[12
]}

机构：

[1] Mayo Clin, Coll Med, Rochester, MN 55905 USA

[2] Univ Calif San Francisco, Sch Med, San Francisco, CA USA

[3] Univ Utah, Sch Med, Salt Lake City, UT USA

[4] Harbor UCLA, Los Angeles Biomed Res Inst, Torrance, CA USA

[5] Univ So Calif, Atherosclerosis Res Unit, Los Angeles, CA USA

[6] Columbia Univ, Coll Phys & Surg, New York, NY USA

[7] Harvard Univ, Sch Med, Boston, MA USA

[8] Univ Washington, Sch Med, Seattle, WA USA

[9] Albert Einstein Coll Med, New York, NY USA

[10] Montefiore Med Ctr, New York, NY USA

[11] Yale Univ, Sch Med, New Haven, CT USA

[12] Kronos Longev Res Inst, Phoenix, AZ USA

来源：

JOURNAL OF CARDIOVASCULAR TRANSLATIONAL RESEARCH | 2009年 / 2卷 / 03期

关键词：

Menopause; Hormone Treatment; Conjugated Equine Estrogen; Women's Health Initiative; Timing Hypothesis; POSTMENOPAUSAL HORMONE-THERAPY; CORONARY-ARTERY ATHEROSCLEROSIS; REPLACEMENT THERAPY; CARDIOVASCULAR-DISEASE; PLUS PROGESTIN; SUBCLINICAL ATHEROSCLEROSIS; BREAST-CANCER; HEART-DISEASE; CIGARETTE-SMOKING; RECEPTOR GENE;

D O I：

10.1007/s12265-009-9104-y

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Observational and epidemiological studies suggest that menopausal hormone therapy (MHT) reduces cardiovascular disease (CVD) risk. However, results from prospective trials showed neutral or adverse effects most likely due to differences in participant demographics, such as age, timing of initiation of treatment, and preexisting cardiovascular disease, which reflected in part the lack of basic science information on mechanisms of action of hormones on the vasculature at the time clinical trials were designed. The Kronos Early Estrogen Replacement Study (KEEPS) is a prospective, randomized, controlled trial designed, using findings from basic science studies, to test the hypothesis that MHT when initiated early in menopause reduces progression of atherosclerosis. KEEPS participants are younger, healthier, and within 3 years of menopause thus matching more closely demographics of women in prior observational and epidemiological studies than women in the Women's Health Initiative hormone trials. KEEPS will provide information relevant to the critical timing hypothesis for MHT use in reducing risk for CVD.

引用

页码：228 / 239

页数：12

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