Estrogen plus Progestin and the Risk of Coronary Heart Disease
http://www.100md.com
2003年8月16日
N Engl J Med Volume 349:523-534 August 7, 2003 Number 6
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
, 百拇医药
ABSTRACT
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).
, 百拇医药
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.
, http://www.100md.com
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.
Fulltext:http://content.nejm.org/cgi/content/full/349/6/523
Related articles:
Waters DD, Alderman EL, Hsia J, et al. Effects of hormone replacement therapy and antioxidant vitamin supplements on coronary atherosclerosis in postmenopausal women: a randomized controlled trial. JAMA 2002;288:2432-2440.[Abstract/Full Text] Mosca L, Collins P, Herrington DM, et al. Hormone replacement therapy and cardiovascular disease: a statement for healthcare professionals from the American Heart Assocation. Circulation 2001;104:499-503.[Full Text] Furberg CD, Vittinghoff E, Davidson M, et al. Subgroup interactions in the Heart and Estrogen/Progestin Replacement Study: lessons learned. Circulation 2002;105:917-922.[Abstract/Full Text] Cushman M, Legault C, Barrett-Connor E, et al. Effect of postmenopausal hormones on inflammation-sensitive proteins: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Study. Circulation 1999;100:717-722.[Abstract/Full Text] Mendelsohn ME, Karas RH. The protective effects of estrogen on the cardiovascular system. N Engl J Med 1999;340:1801-1811.[Full Text] Viscoli CM, Brass LM, Kernan WN, Sarrel PM, Suissa S, Horwitz RI. A clinical trial of estrogen-replacement therapy after ischemic stroke. N Engl J Med 2001;345:1243-1249.[Abstract/Full Text] Wassertheil-Smoller S, Hendrix S, Limacher M, et al. Effect of estrogen plus progestin on stroke in postmenopausal women: the Women's Health Initiative. JAMA 2003;289:2673-2684.[Abstract/Full Text], 百拇医药
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
, 百拇医药
ABSTRACT
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).
, 百拇医药
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.
, http://www.100md.com
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.
Fulltext:http://content.nejm.org/cgi/content/full/349/6/523
Related articles:
Waters DD, Alderman EL, Hsia J, et al. Effects of hormone replacement therapy and antioxidant vitamin supplements on coronary atherosclerosis in postmenopausal women: a randomized controlled trial. JAMA 2002;288:2432-2440.[Abstract/Full Text] Mosca L, Collins P, Herrington DM, et al. Hormone replacement therapy and cardiovascular disease: a statement for healthcare professionals from the American Heart Assocation. Circulation 2001;104:499-503.[Full Text] Furberg CD, Vittinghoff E, Davidson M, et al. Subgroup interactions in the Heart and Estrogen/Progestin Replacement Study: lessons learned. Circulation 2002;105:917-922.[Abstract/Full Text] Cushman M, Legault C, Barrett-Connor E, et al. Effect of postmenopausal hormones on inflammation-sensitive proteins: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Study. Circulation 1999;100:717-722.[Abstract/Full Text] Mendelsohn ME, Karas RH. The protective effects of estrogen on the cardiovascular system. N Engl J Med 1999;340:1801-1811.[Full Text] Viscoli CM, Brass LM, Kernan WN, Sarrel PM, Suissa S, Horwitz RI. A clinical trial of estrogen-replacement therapy after ischemic stroke. N Engl J Med 2001;345:1243-1249.[Abstract/Full Text] Wassertheil-Smoller S, Hendrix S, Limacher M, et al. Effect of estrogen plus progestin on stroke in postmenopausal women: the Women's Health Initiative. JAMA 2003;289:2673-2684.[Abstract/Full Text], 百拇医药