Cited by 779Menopause: Health Impacts and TreatmentsEstrogen and related hormone effectsHormonal and reproductive studies

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Vascular Effects of Early versus Late Postmenopausal Treatment with Estradiol

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Hodis, Howard N., Mack, Wendy J., Henderson, Victor W., Shoupe, Donna, Budoff, Matthew J., Hwang-Levine, Juliana, Li, Yanjie, Feng, Mei, Dustin, Laurie, Kono, Naoko, Stanczyk, Frank Z., Selzer, Robert H., Azen, Stanley P.·2016·New England Journal of Medicine

DOI 10.1056/nejmoa1505241PMC PMC4921205

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Abstract

BACKGROUND: Data suggest that estrogen-containing hormone therapy is associated with beneficial effects with regard to cardiovascular disease when the therapy is initiated temporally close to menopause but not when it is initiated later. However, the hypothesis that the cardiovascular effects of postmenopausal hormone therapy vary with the timing of therapy initiation (the hormone-timing hypothesis) has not been tested. METHODS: A total of 643 healthy postmenopausal women were stratified according to time since menopause (<6 years [early postmenopause] or ≥10 years [late postmenopause]) and were randomly assigned to receive either oral 17β-estradiol (1 mg per day, plus progesterone [45 mg] vaginal gel administered sequentially [i.e., once daily for 10 days of each 30-day cycle] for women with a uterus) or placebo (plus sequential placebo vaginal gel for women with a uterus). The primary outcome was the rate of change in carotid-artery intima-media thickness (CIMT), which was measured every 6 months. Secondary outcomes included an assessment of coronary atherosclerosis by cardiac computed tomography (CT), which was performed when participants completed the randomly assigned regimen. RESULTS: After a median of 5 years, the effect of estradiol, with or without progesterone, on CIMT progression differed between the early and late postmenopause strata (P=0.007 for the interaction). Among women who were less than 6 years past menopause at the time of randomization, the mean CIMT increased by 0.0078 mm per year in the placebo group versus 0.0044 mm per year in the estradiol group (P=0.008). Among women who were 10 or more years past menopause at the time of randomization, the rates of CIMT progression in the placebo and estradiol groups were similar (0.0088 and 0.0100 mm per year, respectively; P=0.29). CT measures of coronary-artery calcium, total stenosis, and plaque did not differ significantly between the placebo group and the estradiol group in either postmenopause stratum. CONCLUSIONS: Oral estradiol therapy was associated with less progression of subclinical atherosclerosis (measured as CIMT) than was placebo when therapy was initiated within 6 years after menopause but not when it was initiated 10 or more years after menopause. Estradiol had no significant effect on cardiac CT measures of atherosclerosis in either postmenopause stratum. (Funded by the National Institute on Aging, National Institutes of Health; ELITE ClinicalTrials.gov number, NCT00114517.).

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Specific Pathways to Prevent Early Vascular Aging
Backer, T. L. M. D., Boutouyrie, P., & Bortel, L. M. V. (2024) · Elsevier eBooks · doi:10.1016/b978-0-443-15512-3.00027-1
Postmenopausal Hormone Replacement Therapy for Health Maintenance during Aging
Kaltoft, L. A. K., Christensen, E., & Kassem, M. S. (2024) · Obstetrics and gynecology. · doi:10.5772/intechopen.114846 · Cited by 1
A influência da reposição hormonal no prognóstico de mulheres pós menopausa com doença arterial coronariana
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Protocolo de tratamiento hormonal sustitutivo en la posmenopausia
López, G. P., Fernández, E. F., Hernando, I. J., & Albarrán, O. G. (2024) · Medicine - Programa de Formación Médica Continuada Acreditado · doi:10.1016/j.med.2024.09.007
Sex Differences in Cardiovascular Complications of Type 2 Diabetes
Kim, D. H., & Kim, S. S. (2024) · Journal of Korean Diabetes · doi:10.4093/jkd.2024.25.4.203
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Alessandro, Z. (2025) · Journal of Cardiology and Cardiovascular Medicine · doi:10.29328/journal.jccm.1001204
Transforming Endometriosis Care: Interview with Andrew Horne
Horne, A. (2025) · EMJ Reproductive Health · doi:10.33590/emjreprohealth/dhpo8497
“34 An additional potential benefit of oral micronised progesterone is promoting quality sleep in menopausal women.”
The Impact of Hormone Therapy on Other Noncommunicable Diseases: Central Nervous System, Cardiovascular Tree, Osteoarthritis, and Cancer
Navarro‐Pardo, E., Mikkola, T. S., Simoncini, T., Millán, M. M., Juliá, M. D., & Cano, A. (2025) · Springer eBooks · doi:10.1007/978-3-031-83979-5_14
Back to hormonal replacement therapy
Trémollières, F., & Gosset, A. (2025) · Joint Bone Spine · doi:10.1016/j.jbspin.2025.105898
Mechanisms of Sex Disparities in Cardiovascular Function and Remodeling
Chaudhari, S. K., Cushen, S. C., Osikoya, O., Jaini, P. A., Posey, R., Mathis, K. W., & Goulopoulou, S. (2019) · Comprehensive physiology · doi:10.1002/j.2040-4603.2019.tb00059.x
Cardiovascular Outcomes of Menopause Hormone Therapy Initiated in Women Aged ≥60 Years, or ≥10 Years Post-menopause: A Systematic Review of the Literature
Garza, N. Y. C., Rivas, J. A. D., Arce, C. F., Ávila, M. E., Castro, C. S., González, S. A. V., Cruz, G. V., Garza, B. M. C., & Neyro, J. L. (2025) · Post Reproductive Health · doi:10.1177/20533691251341713
“23,24 Nevertheless, the primary reason for prescribing hormone therapy remains symptom relief and improvement in quality of life, not primary cardiovascular prevention.”
Menopausal treatment
Gompel, A. (2025) · Elsevier eBooks · doi:10.1016/b978-0-443-13825-6.00256-9
Menopausal Hormone Therapy and Prevention of Cardiovascular Disease
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Current Concepts in Menopausal Hormone Therapy and Breast Cancer
Kling, J. M., & Pederson, H. J. (2025) · Springer eBooks · doi:10.1007/978-3-031-89650-7_9
Menopausal Hormone Therapy in Primary Care: Benefits and Risks, and How to Tailor the Dose
Glynne, S., & Newson, L. R. (2025) · Springer eBooks · doi:10.1007/978-3-031-89650-7_4
Association of hormone therapy with cardiovascular events in females using statins for prevention
Lukey, A., Stuart, G. C. E., Kaur, P., & Hanley, G. E. (2025) · Climacteric · doi:10.1080/13697137.2025.2524171
“It is possible that these individuals already had established lesions, supporting the ‘healthy endothelium’ hypothesis [8,10].”
Influential
Sex steroid hormones and subclinical atherosclerosis progression
Chen, R., Sheng, L., Zhang, X., & Xie, L. (2025) · European Journal of Endocrinology · doi:10.1093/ejendo/lvaf134

Authors: Hodis, H. N., Mack, W. J., Henderson, V. W., Shoupe, D., Budoff, M. J., Hwang-Levine, J., Li, Y., Feng, M., Dustin, L., Kono, N., Stanczyk, F. Z., Selzer, R. H., & Azen, S. P.
Affiliations: General Department of Preventive Medicine (VN)
Stanford University (US)
University of California, Los Angeles (US)
ORCID: Mack, Wendy J.
Henderson, Victor W.
Budoff, Matthew J.
Li, Yanjie
Stanczyk, Frank Z.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2016-03-31
Volume: 374
Issue: 13
Pages: 1221-1231
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1505241
PMC: PMC4921205
OpenAlex: W2330799317
Cited by: 779
References: 42
Citations by year: 2026: 95 · 2025: 67 · 2024: 54 · 2023: 72 · 2022: 80 · 2021: 83 · 2020: 65 · 2019: 77 · 2018: 73 · 2017: 74 · 2016: 36
FWCI: 86.77
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
eScholarship (California Digital Library) (submittedVersion)
Funders: National Institute on Aging (R01-AG024154-S2, R01AG-024154-01-05, R01AG024154, R01AG-024154-06-08)
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
Life Sciences › Biochemistry, Genetics and Molecular Biology › Endocrinology › Estrogen and related hormone effects
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
Keywords: hormone replacement therapy, estradiol, timing of hormone therapy initiation, carotid intima-media thickness, subclinical atherosclerosis, coronary artery calcium, coronary artery stenosis, coronary plaque, cardiovascular risk, menopause, progesterone, oral estradiol, cardiac CT, cardiovascular disease prevention, postmenopausal women
MeSH terms: Administration, Intravaginal, Administration, Oral, Carotid Arteries, Coronary Artery Disease, Drug Administration Schedule, Estradiol, Female, Humans, Middle Aged, Progesterone, Estrogen Replacement Therapy, Linear Models, Postmenopause, Disease Progression, Atherosclerosis, Carotid Intima-Media Thickness

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Vascular Effects of Early versus Late Postmenopausal Treatment with Estradiol

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