The Women's Health Initiative could not have detected cardioprotective effects of starting hormone therapy during the menopausal transition

Naftolin, Frederick; Taylor, Hugh S.; Karas, Richard; Brinton, Eliot; Newman, Isadore; Clarkson, Thomas B.; Mendelsohn, Michael; Lobo, Rogerio A.; Judelson, Debra R.; Nachtigall, Lila E.; Heward, Christopher B.; Hecht, Harvey; Jaff, Michael R.; Harman, S.Mitchell

doi:10.1016/j.fertnstert.2004.02.095

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Volume 81, Issue 6 , Pages 1498-1501, June 2004

The Women's Health Initiative could not have detected cardioprotective effects of starting hormone therapy during the menopausal transition

Frederick Naftolin, M.D., Ph.D.
- Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University, New Haven, Connecticut, USA
- Reprint requests: Frederick Naftolin, M.D., Ph.D., Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University, P.O. Box 208063, New Haven, Connecticut 06520-8063 (FAX: 203-785-5294, USA)
Hugh S. Taylor, M.D.
- Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University, New Haven, Connecticut, USA
Richard Karas, M.D.
- Molecular Cardiology Research Institute, Tufts-New England Medical Center, Boston, Massachusetts, USA
Eliot Brinton, M.D.
- Department of Internal Medicine, Carl T. Hayden VA Medical Center, Phoenix, Arizona, USA
Isadore Newman, Ph.D.
- Institute for Life-Span Development and Gerontology, University of Akron, Akron, Ohio, USA
Thomas B. Clarkson, D.V.M.
- Department of Comparative Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA
Michael Mendelsohn, M.D.
- Molecular Cardiology Research Institute, Tufts-New England Medical Center, Boston, Massachusetts, USA
Rogerio A. Lobo, M.D.
- Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, New York, USA
Debra R. Judelson, M.D.
- Women's Heart Institute, Los Angeles, California, USA
Lila E. Nachtigall, M.D.
- Department of Obstetrics and Gynecology, New York University School of Medicine, New York, New York, USA
Christopher B. Heward, Ph.D.
- Research and Development, The Kronos Group, Phoenix, Arizona, USA
Harvey Hecht, M.D.
- Phillips Ambulatory Care Center, Beth Israel Medical Center, New York, New York, USA
- Vascular Medicine, Lenox Hill Hospital, New York, New York, USA
Michael R. Jaff, M.D.
- Kronos Longevity Research Institute, Phoenix, Arizona, USA
S.Mitchell Harman, M.D., Ph.D.
- Kronos Longevity Research Institute, Phoenix, Arizona, USA

Received 18 November 2003; received in revised form 25 February 2004; accepted 25 February 2004.

Abstract

The Women's Health Initiative (WHI) randomized controlled trial failed to show cardioprotection by estrogen plus progestin treatment of postmenopausal women. But by design, the WHI population was 10-fold underpowered to show cardioprotection of women starting hormone treatment during the menopausal transition. Thus, observational studies that showed cardioprotection in such women remain the only applicable clinical guide to this issue. Randomized controlled trials are urgently needed to test cardioprotection in women starting treatment during the menopausal transition.

Keywords: Menopause, estrogen, progestin, randomized clinical trial, WHI, cardiovascular disease