Cardiometabolic outcomes in Kronos Early Estrogen Prevention Study continuation: 14-year follow-up of a hormone therapy trial

Kejal Kantarci, From the Department of Radiology Mayo Clinic, Rochester, MN.
Nirubol Tosakulwong, Department of Quantitative Health Sciences Mayo Clinic, Rochester, MN.
Timothy G. Lesnick, Department of Quantitative Health Sciences Mayo Clinic, Rochester, MN.
Firat Kara, From the Department of Radiology Mayo Clinic, Rochester, MN.
June Kendall-Thomas, From the Department of Radiology Mayo Clinic, Rochester, MN.
Ekta Kapoor, Department of General Internal Medicine, Mayo Clinic, Rochester, MN.
Julie A. Fields, Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN.
Taryn T. James, Department of Medicine, University of Wisconsin, Madison, WI.
Rogerio A. Lobo, Department of Obstetrics and Gynecology, Columbia University, New York City, NY.
JoAnn E. Manson, Department of Epidemiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Lubna Pal, Department of Obstetrics and Gynecology, Yale University, New Haven, CT.
Dustin B. Hammers, Department of Neurology, Indiane University, Indianapolis, IN.
Michael Malek-Ahmadi, Banner Alzheimer's Institute, Phoenix, AZ.
Marcelle I. Cedars, Department of Obstetrics and Gynecology, University of California, San Francisco, CA.
Frederick N. Naftolin, Department of Obstetrics and Gynecology, New York University, New York, NY.
Nanette Santoro, Department of Obstetrics and Gynecology, University of Colorado, Aurora, CO.
Virginia M. Miller, Department of Surgery, Mayo Clinic, Rochester, MN.
Sherman M. Harman, Department of Medicine, Phoenix VA Health, University of Arizona College of Medicine, Phoenix, AZ.
N Maritza Dowling, Department of Biostatistics, The George Washington University, Washington, DC.
Carey E. Gleason, Department of Medicine, University of Wisconsin, Madison, WI.

Document Type

Journal Article

Publication Date

1-1-2024

Journal

Menopause (New York, N.Y.)

Volume

31

Issue

1

DOI

10.1097/GME.0000000000002278

Abstract

OBJECTIVE: This study aimed to determine long-term cardiometabolic effects of hormone therapies initiated within 3 years of onset of menopause after a 14-year follow-up study of participants of the Kronos Early Estrogen Prevention Study (KEEPS). METHODS: KEEPS was a multisite clinical trial that recruited recently menopausal women with good cardiovascular health for randomization to oral conjugated equine estrogens (Premarin, 0.45 mg/d) or transdermal 17β-estradiol (Climara, 50 μg/d) both with micronized progesterone (Prometrium, 200 mg/d) for 12 d/mo, or placebo pills and patch for 4 years. KEEPS continuation recontacted KEEPS participants 14 years after randomization and 10 years after the completion of the 4-year clinical trial to attend in-person clinic visits. RESULTS: Participants of KEEPS continuation (n = 299 of the 727 KEEPS participants; 41%) had an average age of 67 years (range, 58-73 y). Measurements of systolic and diastolic blood pressures, waist-to-hip ratio, fasting levels of glucose, insulin, lipid profiles, and homeostasis model assessment of insulin resistance were not different among the treatment groups at either KEEPS baseline or at KEEPS continuation visits, or for change between these two visits. The frequency of self-reported diabetes ( P = 0.007) and use of diabetes medications was higher in the placebo than the oral conjugated equine estrogens ( P = 0.045) or transdermal 17β-estradiol ( P = 0.02) groups, but these differences were not supported by the laboratory measurements of glycemia or insulin resistance. CONCLUSIONS: There was no evidence of cardiovascular and/or metabolic benefits or adverse effects associated with 4 years use of oral or transdermal forms of hormone therapy by recently menopausal women with good cardiovascular health after 10 years.

Department

Nursing Faculty Publications

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