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Estrogen in the Prevention of Atherosclerosis: A Randomized, Double-Blind, Placebo-Controlled Trial

Howard N. Hodis, MD; Wendy J. Mack, PhD; Roger A. Lobo, MD; Donna Shoupe, MD; Alex Sevanian, PhD; Peter R. Mahrer, MD; Robert H. Selzer, MS; Chao-ran Liu, MD; Ci-hua Liu, MD; Stanley P. Azen, PhD, Estrogen in the Prevention of Atherosclerosis Trial Research Group*
[+] Article and Author Information

From the University of Southern California Atherosclerosis Research Unit and Kaiser Permanente Medical Center, Los Angeles, and the Jet Propulsion Laboratory/California Institute of Technology, Pasadena, California; and College of Physicians and Surgeons, Columbia University, New York, New York.


Acknowledgments: The authors thank the EPAT participants and their families for their time, effort, and support, and David H. Upmalis, MD, for his insight and foresight in helping us secure funding for this study.

Grant Support: Mead Johnson Laboratories provided an investigator-initiated grant. Also supported in part by grant R01-AG-18798 from the National Institutes of Health. Mead Johnson Laboratories also supplied the micronized 17β-estradiol and placebo pills. Pharmacia & Upjohn Company provided the medroxyprogesterone acetate, Bristol-Myers Squibb Company provided the pravastatin, Merck & Co., Inc., provided the lovastatin and simvastatin, Parke-Davis provided the atorvastatin, and Novartis Pharmaceuticals Corp. provided the fluvastatin.

Requests for Single Reprints: Howard N. Hodis, MD, Atherosclerosis Research Unit, University of Southern California, 2250 Alcazar Street, CSC 132, Los Angeles, CA 90033; e-mail, watcher@usc.edu.

Current Author Addresses: Drs. Hodis, C.-R. Liu, and C.-H. Liu: Atherosclerosis Research Unit, University of Southern California, 2250 Alcazar Street, CSC 132, Los Angeles, CA 90033.

Drs. Mack and Azen: Department of Preventive Medicine, University of Southern California, 1540 Alcazar Street, CHP 218, Los Angeles, CA 90033.

Dr. Lobo: College of Physicians and Surgeons, Columbia University, 622 West 168th Street, New York, NY 10032.

Dr. Shoupe: Women's and Children's Hospital, University of Southern California, 1240 North Mission Road, Room 8K5, Los Angeles, CA 90033.

Dr. Sevanian: School of Pharmacy, University of Southern California, 1985 Zonal Avenue, PSC 612, Los Angeles, CA 90033.

Dr. Mahrer: Kaiser Permanente Medical Center, 1526 North Edgemont Street, Los Angeles, CA 90027.

Mr. Selzer: Jet Propulsion Laboratory, California Institute of Technology, 4800 Oak Grove Drive, Pasadena, CA 91109.

Author Contributions: Conception and design: H.N. Hodis, W.J. Mack, A. Sevanian, P.R. Mahrer, S.P. Azen.

Analysis and interpretation of the data: H.N. Hodis, W.J. Mack, R.A. Lobo, A. Sevanian, S.P. Azen.

Drafting of the article: H.N. Hodis, W.J. Mack, R.A. Lobo, A. Sevanian, S.P. Azen.

Critical revision of the article for important intellectual content: H.N. Hodis, W.J. Mack, R.A. Lobo, D. Shoupe, A. Sevanian, R.H. Selzer, C.-R. Liu, C.-H. Liu, S.P. Azen.

Final approval of the article: H.N. Hodis, W.J. Mack, R.A. Lobo, D. Shoupe, A. Sevanian, P.R. Mahrer, R.H. Selzer, C.-R. Liu, C.-H. Liu, S.P. Azen.

Provision of study materials or patients: H.N. Hodis, R.A. Lobo, P.R. Mahrer, R.H. Selzer.

Statistical expertise: W.J. Mack, S.P. Azen.

Obtaining of funding: H.N. Hodis, R.A. Lobo.

Administrative, technical, or logistic support: H.N. Hodis, D. Shoupe, A. Sevanian, P.R. Mahrer, R.H. Selzer, C.-R. Liu, C.-H. Liu.

Collection and assembly of data: H.N. Hodis, W.J. Mack, D. Shoupe, A. Sevanian, R.H. Selzer, C.-R. Liu, C.-H. Liu.


Ann Intern Med. 2001;135(11):939-953. doi:10.7326/0003-4819-135-11-200112040-00005
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Coronary heart disease is the leading cause of death in women, and mortality rates from this disease substantially and steadily increase after menopause (13). Population studies indicate that estrogen reduces the incidence of coronary heart disease in women. Bilateral oophorectomy before natural menopause increases the risk for coronary heart disease (4). This pattern of risk for coronary heart disease suggests that endogenous estrogens, including 17β-estradiol, play a cardioprotective role before menopause.

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Figure 1.
Profile of the Estrogen in the Prevention of Atherosclerosis Trial.
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Figure 2.
Time course of progression of common carotid artery intima–media thickness in the estradiol (solid lines) and placebo (dotted lines) groups.

Top. Stratified by treatment group. The mean (±SD) baseline intima–media thickness in all 199 evaluable participants (102 placebo recipients and 97 estradiol recipients) was 0.776 ± 0.149 mm compared with 0.752 ± 0.111 mm (P > 0.2). The mean rate of change in intima–media thickness in the placebo and estradiol groups was 0.0036 mm/y versus −0.0017 mm/y (P = 0.046). Middle. Participants not taking lipid-lowering medications. The mean (±SD) baseline intima–media thickness in 77 evaluable participants (35 placebo recipients and 42 estradiol recipients) not taking lipid-lowering medications was 0.799 ± 0.182 mm compared with 0.734 ± 0.111 mm (P = 0.07). The mean rate of change in intima–media thickness in the placebo and estradiol groups was 0.0134 mm/y versus −0.0013 mm/y (P = 0.002). Bottom. Participants taking lipid-lowering medications. The mean (±SD) baseline intima–media thickness in 122 evaluable participants (67 placebo recipients and 55 estradiol recipients) taking lipid-lowering medications was 0.764 ± 0.128 mm compared with 0.766 ± 0.110 mm (P > 0.2). The mean rate of change in intima–media thickness in the placebo and estradiol groups was −0.0016 mm/y versus −0.0019 mm/y (P > 0.2).

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Summary for Patients

Postmenopausal Estrogen Helps Prevent Atherosclerosis in Some Women

The summary below is from the full report titled “Estrogen in the Prevention of Atherosclerosis. A Randomized, Double-Blind, Placebo- Controlled Trial.” It is in the 4 December 2001 issue of Annals of Internal Medicine (volume 135, pages 939-953). The authors are HN Hodis, WJ Mack, RA Lobo, D Shoupe, A Sevanian, PR Mahrer, RH Selzer, C-R Liu, C-H Liu, and SP Azen, for the Estrogen in the Prevention of Atherosclerosis Trial Research Group.

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