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

• DOI: 10.1007/s12265-009-9104-y
• Publication Date: 2009-05-21T21:42:57Z
• Authors: V. M. Miller; D. M. Black; E. A. Brinton; M. J. Budoff; M. I. Cedars; H. N. Hodis; R. A. Lobo; J. E. Manson; G. R. Merriam; F. Naftolin; N. Santoro; H. S. Taylor; S. M. Harman
• Keywords: Aging; Hormone Treatment; Time Factors; Biomedical; menopause; hormone treatment; Pharmaceutical Science; Administration, Oral; Cardiovascular; Conjugated (USP); women’s health initiative; Translational Research, Biomedical; conjugated equine estrogen; 0302 clinical medicine; timing hypothesis; Risk Factors; Genetics(clinical); Prospective Studies; Women's Health Initiative; Progesterone; Estrogens, Conjugated (USP); Estradiol; Estrogen Replacement Therapy; Middle Aged; 3. Good health; Treatment Outcome; Heart Disease; Cardiovascular Diseases; Research Design; 6.1 Pharmaceuticals; Administration; Molecular Medicine; Female; Drug; Menopause; Cardiology and Cardiovascular Medicine; Pulse Therapy; Oral; Adult; Clinical Trials and Supportive Activities; 610; Administration, Cutaneous; Risk Assessment; Article; 03 medical and health sciences; Sex Factors; Double-Blind Method; Clinical Research; Translational Research; Genetics; Humans; Contraception/Reproduction; Prevention; Evaluation of treatments and therapeutic interventions; Estrogens; Estrogen; United States; Cutaneous; Good Health and Well Being; Pulse Therapy, Drug; Conjugated Equine Estrogen; Women's Health; Timing Hypothesis

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.