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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“…function in postmenopausal women, we used data from the Early versus Late Intervention Trial with Estradiol (ELITE), a large randomized clinical trial conducted in cognitively healthy postmenopausal women, 18 to examine whether psychological distress is associated with cognitive performance.”
Cardiovascular risk in hormone replacement therapy
Barcellona, D. (2026) · Bleeding Thrombosis and Vascular Biology · doi:10.4081/btvb.2026.411 · Cited by 1
The missing pieces of menopause science
Nordling, L. (2026) · Nature · doi:10.1038/d41586-026-00692-9 · Cited by 1
Beyond recurrence detection: Treating the forgotten menopause in endometrial cancer survivors
Tjalma, W., Papadimitriou, K., Servayge, J., Altıntaş, S., & Cano, A. (2026) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2026.115065 · Cited by 1
Midlife as the Critical Window for Women’s Stroke and Dementia Prevention: Pivotal Advances and Implementation Priorities
Pikula, A., Iziduh, S., Kocabas, E., Reinders, E. M., de Souza, A. C., & Singh, S. (2026) · Stroke · doi:10.1161/strokeaha.125.051747 · Cited by 1
GPR30-mediated NETs degradation via Trex1 in heart failure of aged female mice
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The Food and Drug Administration boxed warning on menopausal hormone therapy: history, impact, and a regulatory inflection point in women’s health
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Local estrogen therapy effects on DNA methylation dynamics in menopausal women—a cross-sectional preliminary study
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Bioidentical HRT
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“Smaller studies such as KEEPS [7] and ELITE [8] using MP have demonstrated superior outcomes to WHI.”
Menopausal Hormone Therapy and Cardiovascular Risk: Current Evidence and Clinical Implications
Buzdugă, C. M., Bobu, A. M., Covali, R. A., Costea, C. F., Cucu, A. I., Graur, M., Pătrășcanu, E., Solomon-Condriuc, I. P., & Cărăuleanu, A. (2026) · Medical Sciences · doi:10.3390/medsci14020298 · Cited by 1
“…believed to exert cardioprotective effects through favorable effects on lipid metabolism, endothelial function, vascular reactivity, and inflammatory pathways, these physiological benefits have not been consistently reproduced with menopausal hormone therapy in randomized clinical trials [28–30].”
Influential
Efficacy and safety of estrogen therapy for prevention of osteoporosis in postmenopausal women
Stanczyk, F. Z., Winer, S. A., Sriprasert, I., Wong, A., Shoupe, D., & Paulson, R. (2026) · Women s Health · doi:10.1177/17455057261459264 · Cited by 1
“73 A subgroup analysis of the WHI study showed that risk of stroke related to HT in younger menopausal women was rare ( 10/10,000 person-years).”
Obesity, White Matter Hyperintensities, and Cognitive Decline: Sex-Specific DTI-ALPS Index Mediation
Ran, L., Huang, H. T., He, Y., Xing, Q., Fang, Y., Cheng, C., Cheng, M., Yang, W., Xu, S., Luo, X., et al. (2026) · Stroke · doi:10.1161/strokeaha.125.053462 · Cited by 2
Menopausal Hormone Treatment as a Preventive against the Progress of Chronic Diseases in Menopausal Women
Woo, J. Y., & Naftolin, F. N. (2026) · Journal of Menopausal Medicine · doi:10.6118/jmm.26001 · Cited by 1
Menopause and neurological disorders: a roadmap for research
Bove, R. M., & Dobson, R. (2026) · Nature Reviews Neurology · doi:10.1038/s41582-026-01244-5 · Cited by 1
“Several subsequent trials, most notably the ELITE and KEEPS trials, have specifically assessed the effect of MHT on cognition 35,247–251 .”
Influential
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Karam, J., Lau, E. S., & SHUFELT, C. L. (2026) · Obstetrics and Gynecology · doi:10.1097/aog.0000000000006418 · Cited by 1
Estrogen Therapy in 2017
Sylvestre, N., & Kim, C. (2017) · Current Cardiovascular Risk Reports · doi:10.1007/s12170-017-0527-8 · Cited by 1
Sex-Specific Factors in Stroke
Chauhan, A., Moser, H., & McCullough, L. D. (2017) · Springer series in translational stroke research · doi:10.1007/978-3-319-45345-3_32 · Cited by 1
Hormone Therapy Review for Perimenopausal Symptoms: Focused on Perimenopausal Women without Other Risk Factors
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Behandlungsstrategien für Patientinnen mit klimakterischen Beschwerden
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Menopausal hormone therapy and heart disease prevention: desired or valid?
Podzolkov, V. I., Bragina, A. E., & Podzolkovа, N. M. (2019) · CARDIOVASCULAR THERAPY AND PREVENTION · doi:10.15829/1728-8800-2019-3-94-106 · Cited by 2
Menopause
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Management of Risks Factors for Older Women: Osteoporosis and Cardiovascular Disease
Wade, K. S., & Quaas, A. M. (2017) · Springer eBooks · doi:10.1007/978-3-319-17798-4_47 · Cited by 1
Menopause Is a Natural Condition: Does It Require to Be Corrected? For Whom and for How Long?
Fidecicchi, T., Ardito, M., Giannini, A., Simoncini, T., & Genazzani, A. R. (2023) · ISGE series · doi:10.1007/978-3-031-22378-5_12 · Cited by 1
Efek Pemakaian Hormone Replacement Therapy (HRT): Systematic Review
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“(15) Hasil penelitian Hodis et al. (2016) penggunaan HRT pada wanita saat 6 tahun pasca-menopause secara signifikan dapat menurunkan 227 kali risiko Carotid Artery Intima Media Thickness (CIMT) sedangkan penggunaan HRT pada wanita saat 10 tahun pasca-menopause tidak signifikan dapat menurunkan risiko CIMT.”
BackgroundInfluential
O impacto da terapia de reposição hormonal na saúde cardiovascular em mulheres após menopausa: uma revisão de literatura
Costa, A. L. M. P., Melo, L. S., SIQUEIRA, E. L. D., Leite, M. C., Mendes, L. K. L. D. M., Moreira, J. L. S., Cardoso, L. F., Cossi, V. F., Judice, F. S. D. A., & Paiva, B. G. (2023) · Brazilian Journal of Health Review · doi:10.34119/bjhrv6n5-251 · Cited by 1
Vasomotor Symptoms, Cardiovascular Risk and the Role of Physical Activity in Midlife Women
Nilsson, S. (2023) · Linköping University medical dissertations · doi:10.3384/9789180752619 · Cited by 1
Reproductive Factors Linked With Myocardial Fibrosis
Chehab, O., Zeitoun, R., Varadarajan, V., Wu, C. O., Bluemke, D. A., Post, W. S., Michos, E. D., & Lima, J. A. C. (2023) · JACC Advances · doi:10.1016/j.jacadv.2023.100703 · Cited by 1
Avanços na Terapia de Reposição Hormonal na Menopausa: Eficácia e Segurança
Sousa, J. K. S., Neto, A. D. B. C., dos Santos, W. A. F., Carmo, A. S. M. D. S., Madureira, J. M. V., Louro, W. R., Kitayama, N. V., Cruz, L. H., Salvador, B. F., Brito, B. M. V. M., et al. (2024) · Brazilian Journal of Implantology and Health Sciences · doi:10.36557/2674-8169.2024v6n1p2234-2244 · Cited by 1
Sexual and Reproductive Dysfunction in Young Female Cancer Patients
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Alamgir, M. A., Ahmed, I., Raza, H., & Faridudin, F. (2017) · Universal Journal of Clinical Medicine · doi:10.13189/ujcm.2017.050101 · Cited by 1
“The medical literature suggests that ovarian hormones like estrogen can protect vascular endothelium, reduce blood fats and help prevent clotting [5, 6, 7] .”
Background
Menopausale Hormontherapie und Gefäßgesundheit
Franz, M. B. (2017) · gynäkologie + geburtshilfe · doi:10.1007/s15013-017-1142-y · Cited by 1
Sex Differences in Cerebral Ischemia
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Menopausal Hormone Therapy to Prevent Chronic Conditions
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Menopause and Age-Related General Health Risk: A Woman’s Heart Needs Her Hormones
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The Disruptive Changes of Midlife: A Biopsychosocial Adventure
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Sex and Gender Differences in Cardiovascular Disease
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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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