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Cited by 261Menopause: Health Impacts and TreatmentsEstrogen and related hormone effectsLipoproteins and Cardiovascular Health

Heart and Estrogen/progestin Replacement Study (HERS)

Grady, Deborah, Applegate, William, Bush, Trudy, Furberg, Curt, Riggs, Betty, Hulley, Stephen B.·1998·Controlled Clinical Trials
DOI 10.1016/s0197-2456(98)00010-5
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Abstract

The Heart and Estrogen/progestin Replacement Study (HERS) is a randomized, double-blind, placebo-controlled trial designed to test the efficacy and safety of estrogen plus progestin therapy for prevention of recurrent coronary heart disease (CHD) events in women. The participants are postmenopausal women with a uterus and with CHD as evidenced by prior myocardial infarction, coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty, or other mechanical revascularization or at least 50% occlusion of a major coronary artery. Between February 1993 and September 1994, 20 HERS centers recruited and randomized 2763 women. Participants ranged in age from 44 to 79 years, with a mean age of 66.7 (SD 6.7) years. Most participants were white (89%), married (57%), and had completed high school or some college (80%). As expected, the prevalence of coronary risk factors was high: 62% were past or current smokers, 59% had hypertension, 90% had serum LDL-cholesterol of 100 mg/dL or higher, and 23% had diabetes. Each woman was randomly assigned to receive one tablet containing 0.625 mg conjugated estrogens plus 2.5 mg medroxyprogesterone acetate daily or an identical placebo. Participants will be evaluated every 4 months for an average of 4.2 years for the occurrence of CHD events (CHD death and nonfatal myocardial infarction). We will also assess other major CHD endpoints, including revascularization and hospitalization for unstable angina. The primary analysis will compare the rate of CHD events in women assigned to active treatment with the rate in those assigned to placebo. The trial was designed to have power greater than 90% to detect a 35% reduction in the incidence of CHD events, assuming a 50% lag in effect for 2 years and a 5% annual event rate in the placebo group. The design, analysis, and conduct of the study are controlled by the Steering Committee of Principal Investigators and coordinated at the University of California, San Francisco. HERS is the largest trial of any intervention to reduce the risk of recurrent CHD events in women with heart disease and is the first controlled trial to seek evidence of the efficacy and safety of postmenopausal hormone therapy to prevent recurrent CHD events.

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Crossref · 10.1016/s0197-2456(98)00010-5

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  • Suspected cardiovascular events were documented by hospital records and verified by an independent adjudicator using a classification strategy from the Heart and Estrogen/Progestin Replacement Study.

    “Hospital discharge summaries were obtained for each hospitalization, and suspected cardiovascular events were documented by hospital records (based on admission/discharge notes, cardiac enzymes, electrocardiograms, and cardiac tests/procedures) and verified by an independent adjudicator using a classification strategy drawn from the Heart and Estrogen/Progestin Replacement Study.14”

    From Diabetes, the Metabolic Syndrome, and Angiographic Progression of Coronary Arterial Disease in Postmenopausal Women (2006) · cites this paper as [14]

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Authors
Grady, D., Applegate, W., Bush, T., Furberg, C., Riggs, B., & Hulley, S. B.
Affiliations
  • University of California, San Francisco (US)
  • University of Tennessee Health Science Center (US)
  • University of Maryland, Baltimore (US)
  • Wake Forest University Health Sciences (US)
Corresponding author
Grady, Deborah
ORCID
Applegate, William
Venue
Controlled Clinical Trials
Publisher
Elsevier BV
Published
1998-08
Volume
19
Issue
4
Pages
314-335
ISSN
0197-2456 (ISSN-L)
DOI
10.1016/s0197-2456(98)00010-5
OpenAlex
W56609588
Cited by
260
References
24
Citations by year
2026: 3 · 2025: 7 · 2024: 9 · 2023: 3 · 2022: 2 · 2021: 4 · 2020: 5 · 2019: 4 · 2018: 4 · 2017: 9 · 2016: 4 · 2015: 8 · 2014: 7 · 2013: 11 · 2012: 14
FWCI
8.28
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Controlled Clinical Trials (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Estrogen and related hormone effects
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
Keywords
estrogen-progestin therapy, postmenopausal women, coronary artery disease, secondary prevention, myocardial infarction, conjugated estrogens, medroxyprogesterone acetate, hormone replacement therapy, revascularization, unstable angina, coronary risk factors
MeSH terms
Aged, Coronary Disease, Double-Blind Method, Estrogens, Female, Humans, Middle Aged, Risk Factors, Estrogen Replacement Therapy, Medroxyprogesterone Acetate

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