Estrogen plus Progestin and the Risk of Coronary Heart Disease
JoAnn E. Manson, M.D., Dr.P.H., Judith Hsia, M.D., Karen C. Johnson, M.D., M.P.H., Jacques E. Rossouw, M.D., Annlouise R. Assaf, Ph.D., Norman L. Lasser, M.D., Ph.D., Maurizio Trevisan, M.D., Henry R. Black, M.D., Susan R. Heckbert, M.D., Ph.D., Robert Detrano, M.D., Ph.D., Ora L. Strickland, Ph.D., Nathan D. Wong, Ph.D., John R. Crouse, M.D., Evan Stein, M.D., Mary Cushman, M.D., for the Women's Health Initiative Investigators
Background Recent randomized clinical trials have suggestedthat estrogen plus progestin does not confer cardiac protectionand may increase the risk of coronary heart disease (CHD). Inthis report, we provide the final results with regard to estrogenplus progestin and CHD from the Women's Health Initiative (WHI).
Methods The WHI included a randomized primary-prevention trialof estrogen plus progestin in 16,608 postmenopausal women whowere 50 to 79 years of age at base line. Participants were randomlyassigned to receive conjugated equine estrogens (0.625 mg perday) plus medroxyprogesterone acetate (2.5 mg per day) or placebo.The primary efficacy outcome of the trial was CHD (nonfatalmyocardial infarction or death due to CHD).
Results After a mean follow-up of 5.2 years (planned duration,8.5 years), the data and safety monitoring board recommendedterminating the estrogen-plus-progestin trial because the overallrisks exceeded the benefits. Combined hormone therapy was associatedwith a hazard ratio for CHD of 1.24 (nominal 95 percent confidenceinterval, 1.00 to 1.54; 95 percent confidence interval afteradjustment for sequential monitoring, 0.97 to 1.60). The elevationin risk was most apparent at one year (hazard ratio, 1.81 [95percent confidence interval, 1.09 to 3.01]). Although higherbase-line levels of low-density lipoprotein cholesterol wereassociated with an excess risk of CHD among women who receivedhormone therapy, higher base-line levels of C-reactive protein,other biomarkers, and other clinical characteristics did notsignificantly modify the treatment-related risk of CHD.
Conclusions Estrogen plus progestin does not confer cardiacprotection and may increase the risk of CHD among generallyhealthy postmenopausal women, especially during the first yearafter the initiation of hormone use. This treatment should notbe prescribed for the prevention of cardiovascular disease.
Source Information
From the Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston (J.E.M.); the Department of Medicine, George Washington University, Washington, D.C. (J.H.); the Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis (K.C.J.); the Program Office, National Heart, Lung, and Blood Institute, Bethesda, Md. (J.E.R.); Memorial Hospital, Brown Medical School, Pawtucket, R.I. (A.R.A.); the Preventive Cardiology Program, New Jersey Medical School, Newark (N.L.L.); the Department of Social and Preventive Medicine, University at Buffalo, Buffalo, N.Y. (M.T.); the Department of Preventive Medicine, Rush–Presbyterian–St. Luke's Medical Center, Chicago (H.R.B.); the Department of Epidemiology, University of Washington, Seattle (S.R.H.); the Division of Cardiology, Harbor–UCLA Research and Education Institute, Torrance, Calif. (R.D.); the Woodruff School of Nursing, Emory University, Atlanta (O.L.S.); the Heart Disease Prevention Program, University of California, Irvine (N.D.W.); the Department of Medicine, Wake Forest University, Winston-Salem, N.C. (J.R.C.); Medical Research Laboratories International, Highland Heights, Ky. (E.S.); and the Departments of Medicine and Pathology, University of Vermont, Burlington (M.C.).
Address reprint requests to Dr. Manson at the Divison of Preventive Medicine, Brigham and Women's Hospital, 900 Commonwealth Ave., Boston, MA 02215, or at jmanson{at}rics.bwh.harvard.edu.
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