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2 May 2000 | Volume 132 Issue 9 | Pages 689-696
Background: Oral contraceptive use increases risk for venous thromboembolism, but data on the effect of postmenopausal hormone therapy are limited.
Objective: To determine the effect of therapy with estrogen plus progestin on risk for venous thromboembolic events in postmenopausal women.
Design: Randomized, double-blind, placebo-controlled trial.
Setting: 20 clinical centers in the United States.
Participants: 2763 postmenopausal women younger than 80 years of age (mean age, 67 years) who had coronary heart disease but no previous venous thromboembolism and had not had a hysterectomy.
Intervention: Conjugated equine estrogens, 0.625 mg, plus medroxyprogesterone acetate, 2.5 mg, in one tablet (n = 1380) or placebo that was identical in appearance (n = 1383).
Measurements: Documented deep venous thrombosis or pulmonary embolism.
Results: During an average of 4.1 years of follow-up, 34 women in the hormone therapy group and 13 in the placebo group experienced venous thromboembolic events (relative hazard, 2.7 [95% CI, 1.4 to 5.0] [P = 0.003]; excess risk, 3.9 per 1000 woman-years [CI, 1.4 to 6.4 per 1000 woman-years]; number needed to treat for harm, 256 [CI, 157 to 692]). In multivariate analysis, the risk for venous thromboembolism was increased among women who had lower-extremity fractures (relative hazard, 18.1 [CI, 5.4 to 60.4]) or cancer (relative hazard, 3.9 [CI, 1.6 to 9.4]) and for 90 days after inpatient surgery (relative hazard, 4.9 [CI, 2.4 to 9.8]) or nonsurgical hospitalization (relative hazard, 5.7 [CI, 3.0 to 10.8]). Risk was decreased with aspirin (relative hazard, 0.5 [CI, 0.2 to 0.8]) or statin use (relative hazard, 0.5 [CI, 0.2 to 0.9]).
Conclusions: Postmenopausal therapy with estrogen plus progestin increases risk for venous thromboembolism in women with coronary heart disease. This risk should be considered when the risks and benefits of therapy are being weighed.
Author and Article Information
From the University of California, San Francisco, San Francisco, California; Emory University School of Medicine, Atlanta, Georgia; Wake Forest University School of Medicine, Winston-Salem, North Carolina; Cedars-Sinai Medical Center, Los Angeles, California; and University of Minnesota, Minneapolis, Minnesota.
Acknowledgments: The authors thank Josephine Fong for performing statistical analyses.
Grant Support: By Wyeth-Ayerst Laboratories.
Requests for Single Reprints: Deborah Grady, MD, MPH, University of California, San Francisco, 74 New Montgomery Street, Suite 600, San Francisco, CA 94105.
Requests To Purchase Bulk Reprints (minimum, 100 copies): the Reprints Coordinator; phone, 215-351-2657; e-mail, reprints{at}mail.acponline.org.
Current Author Addresses: Drs. Grady, Vittinghoff, and Hulley: University of California, San Francisco, 74 New Montgomery Street, Suite 600, San Francisco, CA 94105.
Dr. Wenger: Emory University School of Medicine, 69 Butler Street SE, Atlanta, GA 30303.
Drs. Herrington and Furberg: Wake Forest University School of Medicine, One Medical Center Boulevard, Winston-Salem, NC 27157-1066.
Dr. Khan: Cedars-Sinai Medical Center, 444 South San Vicente Boulevard, Suite 903, Los Angeles, CA 90048-4174.
Dr. Hunninghake: Heart Disease Prevention Clinic, Box 192, 151 Variety Club Heart and Research Center, 401 East River Parkway, Minneapolis, MN 55455.
Author Contributions: Conception and design: D. Grady, N.K. Wenger, S. Hulley.
Analysis and interpretation of the data: D. Grady, N.K. Wenger, D. Herrington, S. Khan, C. Furberg, D. Hunninghake, E. Vittinghoff, S. Hulley.
Drafting of the article: D. Grady.
Critical revision of the article for important intellectual content: D. Grady, N.K. Wenger, D. Herrington, S. Khan, C. Furberg, D. Hunninghake, S. Hulley.
Final approval of the article: D. Grady, N.K. Wenger, D. Herrington, S. Khan, C. Furberg, D. Hunninghake, E. Vittinghoff, S. Hulley.
Provision of study materials or patients: N.K. Wenger, D. Herrington, S. Khan, D. Hunninghake.
Statistical expertise: E. Vittinghoff, S. Hulley.
Obtaining of funding: D. Grady, C. Furberg, D. Hunninghake, S. Hulley.
Administrative, technical, or logistic support: D. Grady, S. Hulley.
Collection and assembly of data: D. Grady, S. Khan. ARTICLE
Postmenopausal Hormone Therapy Increases Risk for Venous Thromboembolic Disease: The Heart and Estrogen/progestin Replacement Study
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B. G. Angeja, M. G. Shlipak, A. S. Go, S. C. Johnston, P. D. Frederick, J. G. Canto, H. V. Barron, D. Grady, and for the National Registry of Myocardial Infarction Hormone therapy and the risk of stroke after acute myocardial infarction in postmenopausal women J. Am. Coll. Cardiol., November 1, 2001; 38(5): 1297 - 1301. [Abstract] [Full Text] [PDF]
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L. Wartofsky Update in Endocrinology Ann Intern Med, October 16, 2001; 135(8_Part_1): 601 - 609. [Full Text] [PDF]
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J. C. LaRosa Prevention and Treatment of Coronary Heart Disease: Who Benefits? Circulation, October 2, 2001; 104(14): 1688 - 1692. [Abstract] [Full Text] [PDF]
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J. Lorraine Raloxifene and breast cancer Can. Med. Assoc. J., October 1, 2001; 165(7): 888 - 888. [Full Text] [PDF]
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 D.M. Herrington Effects of oestrogen on cardiovascular events in postmenopausal women Eur. Heart J. Suppl., October 1, 2001; 3(suppl_M): M7 - M11. [Abstract] [PDF]
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 V. G. Vogel Reducing the Risk of Breast Cancer With Tamoxifen in Women at Increased Risk J. Clin. Oncol., September 15, 2001; 19(90001): 87s - 92. [Abstract] [Full Text] [PDF]
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M. D. P. Luyer, S. Khosla, W. G. Owen, and V. M. Miller Prospective Randomized Study of Effects of Unopposed Estrogen Replacement Therapy on Markers of Coagulation and Inflammation in Postmenopausal Women J. Clin. Endocrinol. Metab., August 1, 2001; 86(8): 3629 - 3634. [Abstract] [Full Text] [PDF]
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L. Mosca, P. Collins, D. M. Herrington, M. E. Mendelsohn, R. C. Pasternak, R. M. Robertson, K. Schenck-Gustafsson, S. C. Smith Jr, K. A. Taubert, and N. K. Wenger Hormone Replacement Therapy and Cardiovascular Disease: A Statement for Healthcare Professionals From the American Heart Association Circulation, July 24, 2001; 104(4): 499 - 503. [Full Text] [PDF]
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J. E. Manson and K. A. Martin Postmenopausal Hormone-Replacement Therapy N. Engl. J. Med., July 5, 2001; 345(1): 34 - 40. [Full Text] [PDF]
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K. P. Alexander, L. K. Newby, A. S. Hellkamp, R. A. Harrington, E. D. Peterson, S. Kopecky, A. Langer, P. O'Gara, C. M. O'Connor, R. N. Daly, et al. Initiation of hormone replacement therapy after acute myocardial infarction is associated with more cardiac events during follow-up J. Am. Coll. Cardiol., July 1, 2001; 38(1): 1 - 7. [Abstract] [Full Text] [PDF]
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D. Grady and S. B. Hulley Postmenopausal hormones and heart disease J. Am. Coll. Cardiol., July 1, 2001; 38(1): 8 - 10. [Full Text] [PDF]
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D. Grady and S. R. Cummings Postmenopausal Hormone Therapy for Prevention of Fractures: How Good Is the Evidence? JAMA, June 13, 2001; 285(22): 2909 - 2910. [Full Text] [PDF]
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J. G. Ray, M. Mamdani, R. T. Tsuyuki, D. R. Anderson, E. L. Yeo, and A. Laupacis Use of Statins and the Subsequent Development of Deep Vein Thrombosis Arch Intern Med, June 11, 2001; 161(11): 1405 - 1410. [Abstract] [Full Text] [PDF]
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 E. Barrett-Connor and C. A Stuenkel Hormone replacement therapy (HRT)-- risks and benefits Int. J. Epidemiol., June 1, 2001; 30(3): 423 - 426. [Full Text] [PDF]
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 D. Brighouse Hormone replacement therapy (HRT) and anaesthesia Br. J. Anaesth., May 1, 2001; 86(5): 709 - 716. [Abstract] [Full Text] [PDF]
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W. H. Geerts, J. A. Heit, G. P. Clagett, G. F. Pineo, C. W. Colwell, F. A. Anderson Jr., and H. B. Wheeler Prevention of Venous Thromboembolism Chest, January 1, 2001; 119(1_suppl): 132S - 175S. [Full Text] [PDF]
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 D. Atkins and J. Miller Hormone replacement therapy was associated with increased venous thromboembolism and deep venous thrombosis Evid. Based Med., November 1, 2000; 5(6): 175 - 175. [Full Text]
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 L. S Giddings Oestrogen plus progestin increased venous thromboembolic disease in postmenopausal women with coronary artery disease Evid. Based Nurs., October 1, 2000; 3(4): 123 - 123. [Full Text]
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 Postmenopausal Hormone Therapy Increases Risk of Venous Thromboembolism Journal Watch Women's Health, July 1, 2000; 2000(701): 3 - 3. [Full Text]
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 Postmenopausal HRT and Venous Thromboembolism Journal Watch Cardiology, June 30, 2000; 2000(630): 5 - 5. [Full Text]
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S. R. Cummings and D. C. Bauer Do Statins Prevent Both Cardiovascular Disease and Fracture? JAMA, June 28, 2000; 283(24): 3255 - 3257. [Full Text] [PDF]
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 HRT Increases Risk for DVT and PE Journal Watch (General), May 16, 2000; 2000(516): 1 - 1. [Full Text]
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E. M. Brooks-Asplund, A. A. Shoukas, S.-Y. Kim, S. A. Burke, and D. E. Berkowitz Estrogen has opposing effects on vascular reactivity in obese, insulin-resistant male Zucker rats J Appl Physiol, May 1, 2002; 92(5): 2035 - 2044. [Abstract] [Full Text] [PDF]
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