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Effect of Estrogen plus Progestin on Risk for Biliary Tract Surgery in Postmenopausal Women with Coronary Artery Disease: The Heart and Estrogen/progestin Replacement Study

Joel A. Simon, MD, MPH; Donald B. Hunninghake, MD; Sanjay K. Agarwal, MD; Feng Lin, MS; Jane A. Cauley, DrPH; Christine C. Ireland, MPH; James H. Pickar, MD, Heart and Estrogen/progestin Replacement Study (HERS) Research Group
[+] Article and Author Information

From Veterans Affairs Medical Center, San Francisco, and University of California, San Francisco, School of Medicine, San Francisco, California; Burns and Allen Research Institute, Cedars-Sinai Medical Center, Los Angeles, California; University of Minnesota School of Medicine, Minneapolis, Minnesota; Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania; and Wyeth-Ayerst Research, Radnor, Pennsylvania.


Disclosures: Dr. Picker is a full-time salaried employee of Wyeth-Ayerst Research; all other authors received research support (for most authors, specifically for work on the HERS trial) from Wyeth-Ayerst Research. Dr. Agarwal is a speaker for Wyeth-Ayerst Research and for Pfizer, Inc. Dr. Simon has received donations (for research on vitamin C) from Roche Vitamins, Inc., and is a member of the scientific advisory committee to the California Walnut Marketing Board. Dr. Cauley has received research support from Roche Pharmaceuticals, honoraria from Proctor & Gamble, and both research support and honoraria from Eli Lilly and Co. and Merck & Co., Inc.

Acknowledgments: The authors thank Josephine Fong, MS, for help with the initial data analyses and Eric Vittinghoff, PhD, for assistance in developing the statistical approaches used in the final analyses.

Grant Support: By Wyeth-Ayerst Laboratories.

Requests for Single Reprints: Joel A. Simon, MD, MPH, General Internal Medicine Section (111A1), San Francisco Veterans Affairs Medical Center, 4150 Clement Street, San Francisco, California 94121; e-mail, jasimon@itsa.ucsf.edu.

Current Author Addresses: Dr. Simon: General Internal Medicine Section (111A1), Medical Service, Veterans Affairs Medical Center, San Francisco, CA 94121.

Dr. Hunninghake: Heart Disease Prevention Clinic, Box 192, 151 Variety Club Heart and Research Center, 401 East River Parkway, Minneapolis, MN 55455.

Dr. Agarwal: Department of Obstetrics and Gynecology, Burns and Allen Research Institute, Cedars-Sinai Medical Center, 8635 West 3rd Street, Suite 160, Los Angeles, CA 90048.

Ms. Lin and Ms. Ireland: Prevention Sciences Group, Department of Epidemiology and Biostatistics, School of Medicine, University of California, San Francisco, 74 New Montgomery Street, Suite 600, San Francisco, CA 94105.

Dr. Cauley: Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, 130 DeSoto Street, Pittsburgh, PA 15261.

Dr. Pickar: Wyeth-Ayerst Research, Box 42528, Philadelphia, PA 19101.

Author Contributions: Conception and design: J.A. Simon.

Analysis and interpretation of the data: J.A. Simon, D.B. Hunninghake, S.K. Agarwal, J.H. Pickar.

Drafting of the article: J.A. Simon, D.B. Hunninghake, S.K. Agarwal, J.H. Pickar.

Critical revision of the article for important intellectual content: J.A. Simon, S.K. Agarwal, J.A. Cauley, C.C. Ireland.

Final approval of the article: J.A. Simon, D.B. Hunninghake, F. Lin, J.A. Cauley.

Provision of study materials or patients: D.B. Hunninghake, S.K. Agarwal.

Statistical expertise: F. Lin.

Administrative, technical, or logistic support: C.C. Ireland.

Collection and assembly of data: S.K. Agarwal, J.A. Cauley.


Ann Intern Med. 2001;135(7):493-501. doi:10.7326/0003-4819-135-7-200110020-00008
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Data from the Third National Health and Nutrition Examination Survey (1) indicate that 11% of U.S. women have a history of clinical gallbladder disease—that is, either previous cholecystectomy or self-reported history of gallstones. Factors associated with gallbladder disease, at least in some studies, include older age, female sex, white ethnicity/race, obesity, rapid weight loss, and, among women, greater parity, use of oral estrogen–containing contraceptives, and postmenopausal estrogen therapy (2). These associations, in general, have been based on observational data and may partly reflect the effects of ascertainment and recall bias, as well as confounding. While some observational studies suggest that estrogens increase the risk for gallbladder disease by as much as twofold to fourfold (3), such an association has not been reported consistently (23). The effect of combined estrogen plus progestin therapy has been less well studied, and no recent clinical trial data exist on the relation of such therapy to the risk for biliary tract surgery among postmenopausal women.

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Figures

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Figure.
Kaplan–Meier estimates of cumulative incidence of biliary tract surgery among postmenopausal women receiving estrogen plus progestin (solid line) or placebo (dotted line).

The number of women still free of biliary tract surgery at each follow-up year is noted in parentheses; the lines become thinner when this number becomes smaller than half the cohort size.

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Summary for Patients

Hormone Replacement Therapy in Postmenopausal Women with Heart Disease and Risk for Gallstones That Require Surgery

The summary below is from the full report titled “Effect of Estrogen plus Progestin on Risk for Biliary Tract Surgery in Postmenopausal Women with Coronary Artery Disease. The Heart and Estrogen/progestin Replacement Study.” It is in the 2 October 2001 issue of Annals of Internal Medicine (volume 135, pages 493-501). The authors are JA Simon, DB Hunninghake, SK Agarwal, F Lin, JA Cauley, CC Ireland, and JH Pickar, for the Heart and Estrogen/progestin Replacement Study (HERS) Research Group.

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