Estrogen plus progestin and the risk of coronary heart disease

被引:1504
作者
Manson, JE
Hsia, J
Johnson, KC
Rossouw, JE
Assaf, AR
Lasser, NL
Trevisan, M
Black, HR
Heckbert, SR
Detrano, R
Strickland, OL
Wong, ND
Crouse, JR
Stein, E
Cushman, M
Alving, B
Rossouw, JE
Pottern, L
Ludlam, S
McGowan, JA
Prentice, R
Anderson, G
LaCroix, A
Patterson, R
McTiernan, A
Cochrane, B
Hunt, J
Tinker, L
Kooperberg, C
McIntosh, M
Wang, CY
Chen, C
Bowen, D
Kristal, A
Stanford, J
Urban, N
Weiss, N
White, E
Shumaker, S
Rautaharju, P
Prineas, R
Naughton, M
Stein, E
Laskarzewski, P
Cummings, S
Nevitt, M
Dockrell, M
Harnack, L
Cammarata, F
Lindenfelser, S
机构
[1] Brigham & Womens Hosp, Div Prevent Med, Boston, MA 02215 USA
[2] George Washington Univ, Dept Med, Washington, DC USA
[3] Univ Tennessee, Hlth Sci Ctr, Dept Prevent Med, Memphis, TN USA
[4] NHLBI, Program Off, Bethesda, MD 20892 USA
[5] Brown Univ, Mem Hosp, Sch Med, Pawtucket, RI USA
[6] Univ Med & Dent New Jersey, New Jersey Med Sch, Prevent Cardiol Program, Newark, NJ 07103 USA
[7] Univ Buffalo, Dept Social & Prevent Med, Buffalo, NY USA
[8] Rush Presbyterian St Lukes Med Ctr, Dept Prevent Med, Chicago, IL 60612 USA
[9] Univ Washington, Dept Epidemiol, Seattle, WA 98195 USA
[10] Univ Calif Los Angeles, Div Cardiol, Harbor Res & Educ Inst, Torrance, CA USA
[11] Emory Univ, Woodruff Sch Nursing, Atlanta, GA 30322 USA
[12] Univ Calif Irvine, Heart Dis Prevent Program, Irvine, CA 92717 USA
[13] Wake Forest Univ, Dept Med, Winston Salem, NC 27109 USA
[14] Med Res Labs Int, Highland Hts, KY USA
[15] Univ Vermont, Coll Med, Dept Med, Burlington, VT 05405 USA
[16] Univ Vermont, Coll Med, Dept Pathol, Burlington, VT 05405 USA
[17] Harvard Univ, Sch Med, Boston, MA USA
关键词
D O I
10.1056/NEJMoa030808
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND: Recent randomized clinical trials have suggested that estrogen plus progestin does not confer cardiac protection and may increase the risk of coronary heart disease (CHD). In this report, we provide the final results with regard to estrogen plus progestin and CHD from the Women's Health Initiative (WHI). METHODS: The WHI included a randomized primary-prevention trial of estrogen plus progestin in 16,608 postmenopausal women who were 50 to 79 years of age at base line. Participants were randomly assigned to receive conjugated equine estrogens (0.625 mg per day) plus medroxyprogesterone acetate (2.5 mg per day) or placebo. The primary efficacy outcome of the trial was CHD (nonfatal myocardial 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 recommended terminating the estrogen-plus-progestin trial because the overall risks exceeded the benefits. Combined hormone therapy was associated with a hazard ratio for CHD of 1.24 (nominal 95 percent confidence interval, 1.00 to 1.54; 95 percent confidence interval after adjustment for sequential monitoring, 0.97 to 1.60). The elevation in risk was most apparent at one year (hazard ratio, 1.81 [95 percent confidence interval, 1.09 to 3.01]). Although higher base-line levels of low-density lipoprotein cholesterol were associated with an excess risk of CHD among women who received hormone therapy, higher base-line levels of C-reactive protein, other biomarkers, and other clinical characteristics did not significantly modify the treatment-related risk of CHD. CONCLUSIONS: Estrogen plus progestin does not confer cardiac protection and may increase the risk of CHD among generally healthy postmenopausal women, especially during the first year after the initiation of hormone use. This treatment should not be prescribed for the prevention of cardiovascular disease.
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收藏
页码:523 / 534
页数:12
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