Using basic science to design a clinical trial: Baseline characteristics of women enrolled in the kronos early estrogen prevention study (KEEPS)

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

Research output: Contribution to journalReview article

105 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)228-239
Number of pages12
JournalJournal of cardiovascular translational research
Volume2
Issue number3
DOIs
StatePublished - Sep 2009

Keywords

  • Conjugated Equine Estrogen
  • Hormone Treatment
  • Menopause
  • Timing Hypothesis
  • Women's Health Initiative

ASJC Scopus subject areas

  • Molecular Medicine
  • Genetics
  • Pharmaceutical Science
  • Cardiology and Cardiovascular Medicine
  • Genetics(clinical)

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    Miller, V. M., Black, D. M., Brinton, E. A., Budoff, M. J., Cedars, M. I., Hodis, H. N., Lobo, R. A., Manson, J. E., Merriam, G. R., Naftolin, F., Santoro, N., Taylor, H. S., & Harman, S. M. (2009). Using basic science to design a clinical trial: Baseline characteristics of women enrolled in the kronos early estrogen prevention study (KEEPS). Journal of cardiovascular translational research, 2(3), 228-239. https://doi.org/10.1007/s12265-009-9104-y