Conjugated equine estrogens and coronary heart disease

The women's health initiative

Judith Hsia, Robert D. Langer, Jo Ann E. Manson, Lewis Kuller, Karen Johnson, Susan L. Hendrix, Mary Pettinger, Susan R. Heckbert, Nancy Greep, Sybil Crawford, Charles B. Eaton, John B. Kostis, Pat Caralis, Ross Prentice

Research output: Contribution to journalArticle

505 Citations (Scopus)

Abstract

Background: In recent randomized trials, conjugated equine estrogens (CEE) with continuous medroxyprogesterone acetate provided no protection against coronary heart disease in postmenopausal women and may have increased cardiac risk. These trials did not address the role of unopposed estrogen for coronary protection. Methods: A total of 10 739 women aged 50 to 79 years at baseline (mean age, 63.6 years) who had previously undergone hysterectomy were randomized to receive CEE, 0.625 mg/d, or placebo at 40 US clinical centers beginning in 1993. The trial was terminated early after 6.8 years of follow-up (planned duration, 8.5 years). This report includes final, centrally adjudicated results for the primary efficacy outcome (myocardial infarction or coronary death), secondary coronary outcomes, and subgroup analyses. Results: During the active intervention period, 201 coronary events were confirmed among women assigned to receive CEE compared with 217 events among women assigned to receive placebo (hazard ratio, 0.95; nominal 95% confidence interval, 0.79-1.16). Among women aged 50 to 59 years at baseline, the hazard ratio for the primary outcome was 0.63 (nominal 95% confidence interval, 0.36-1.08). In that age group, coronary revascularization was less frequent among women assigned to receive CEE (hazard ratio, 0.55; nominal 95% confidence interval, 0.35-0.86), as were several composite outcomes, which included the primary outcome and coronary revascularization (hazard ratio, 0.66; nominal 95% confidence interval, 0.44-0.97). Conclusions: Conjugated equine estrogens provided no overall protection against myocardial infarction or coronary death in generally healthy postmenopausal women during a 7-year period of use. There was a suggestion of lower coronary heart disease risk with CEE among women 50 to 59 years of age at baseline.

Original languageEnglish (US)
Pages (from-to)357-365
Number of pages9
JournalArchives of Internal Medicine
Volume166
Issue number3
DOIs
StatePublished - Feb 13 2006

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Conjugated (USP) Estrogens
Women's Health
Coronary Disease
Confidence Intervals
Myocardial Infarction
Placebos
Medroxyprogesterone Acetate
Hysterectomy
Estrogens
Age Groups

All Science Journal Classification (ASJC) codes

  • Internal Medicine

Cite this

Hsia, J., Langer, R. D., Manson, J. A. E., Kuller, L., Johnson, K., Hendrix, S. L., ... Prentice, R. (2006). Conjugated equine estrogens and coronary heart disease: The women's health initiative. Archives of Internal Medicine, 166(3), 357-365. https://doi.org/10.1001/archinte.166.3.357

Conjugated equine estrogens and coronary heart disease : The women's health initiative. / Hsia, Judith; Langer, Robert D.; Manson, Jo Ann E.; Kuller, Lewis; Johnson, Karen; Hendrix, Susan L.; Pettinger, Mary; Heckbert, Susan R.; Greep, Nancy; Crawford, Sybil; Eaton, Charles B.; Kostis, John B.; Caralis, Pat; Prentice, Ross.

In: Archives of Internal Medicine, Vol. 166, No. 3, 13.02.2006, p. 357-365.

Research output: Contribution to journalArticle

Hsia, J, Langer, RD, Manson, JAE, Kuller, L, Johnson, K, Hendrix, SL, Pettinger, M, Heckbert, SR, Greep, N, Crawford, S, Eaton, CB, Kostis, JB, Caralis, P & Prentice, R 2006, 'Conjugated equine estrogens and coronary heart disease: The women's health initiative', Archives of Internal Medicine, vol. 166, no. 3, pp. 357-365. https://doi.org/10.1001/archinte.166.3.357
Hsia, Judith ; Langer, Robert D. ; Manson, Jo Ann E. ; Kuller, Lewis ; Johnson, Karen ; Hendrix, Susan L. ; Pettinger, Mary ; Heckbert, Susan R. ; Greep, Nancy ; Crawford, Sybil ; Eaton, Charles B. ; Kostis, John B. ; Caralis, Pat ; Prentice, Ross. / Conjugated equine estrogens and coronary heart disease : The women's health initiative. In: Archives of Internal Medicine. 2006 ; Vol. 166, No. 3. pp. 357-365.
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abstract = "Background: In recent randomized trials, conjugated equine estrogens (CEE) with continuous medroxyprogesterone acetate provided no protection against coronary heart disease in postmenopausal women and may have increased cardiac risk. These trials did not address the role of unopposed estrogen for coronary protection. Methods: A total of 10 739 women aged 50 to 79 years at baseline (mean age, 63.6 years) who had previously undergone hysterectomy were randomized to receive CEE, 0.625 mg/d, or placebo at 40 US clinical centers beginning in 1993. The trial was terminated early after 6.8 years of follow-up (planned duration, 8.5 years). This report includes final, centrally adjudicated results for the primary efficacy outcome (myocardial infarction or coronary death), secondary coronary outcomes, and subgroup analyses. Results: During the active intervention period, 201 coronary events were confirmed among women assigned to receive CEE compared with 217 events among women assigned to receive placebo (hazard ratio, 0.95; nominal 95{\%} confidence interval, 0.79-1.16). Among women aged 50 to 59 years at baseline, the hazard ratio for the primary outcome was 0.63 (nominal 95{\%} confidence interval, 0.36-1.08). In that age group, coronary revascularization was less frequent among women assigned to receive CEE (hazard ratio, 0.55; nominal 95{\%} confidence interval, 0.35-0.86), as were several composite outcomes, which included the primary outcome and coronary revascularization (hazard ratio, 0.66; nominal 95{\%} confidence interval, 0.44-0.97). Conclusions: Conjugated equine estrogens provided no overall protection against myocardial infarction or coronary death in generally healthy postmenopausal women during a 7-year period of use. There was a suggestion of lower coronary heart disease risk with CEE among women 50 to 59 years of age at baseline.",
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