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Vascular Effects of Early versus Late Postmenopausal Treatment with Estradiol
Open accessAbstract
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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“One included study (35) was an observational analysis of CV events of a randomized trial evaluating electrocautery of ovaries versus gonadotropins in women with clomipheneresistant polycystic ovarian syndrome (36).”
From Cardiovascular Risk Following Fertility Therapy (2017) · cites this paper as [36]
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LIU, J. H. (2021) · Clinical Obstetrics & Gynecology · doi:10.1097/grf.0000000000000657 · Cited by 10
Inayama, Y., Mizuno, K., Yamaguchi, K. D., Hamanishi, J., Takeuchi, M., Egawa, M., Mandai, M., & Kawakami, K. (2023) · Journal of obstetrics and gynaecology research · doi:10.1111/jog.15653 · Cited by 10
“Since WHI study included women 10 years after menopause, studies targeting younger populations were conducted.(9,10) Subsequent studies confirmed the benefits of HRT for the prevention of osteoporosis and fractures.”
BackgroundVascular Effects of Progestogens
Ruan, X., & Mueck, A. O. (2019) · ISGE series · doi:10.1007/978-3-030-11355-1_13 · Cited by 9
Sex steroid hormones and subclinical atherosclerosis progression in postmenopausal women
Chen, I., Stanczyk, F. Z., Sriprasert, I., Karim, R., Shoupe, D., Kono, N., Hodis, H. N., & Mack, W. J. (2025) · European Journal of Endocrinology · doi:10.1093/ejendo/lvaf032 · Cited by 9
Stanczyk, F. Z., Yang, J. L., Bennink, H. J. T. C., Sriprasert, I., Winer, S. A., Foidart, J., & Archer, D. F. (2025) · Menopause The Journal of The North American Menopause Society · doi:10.1097/gme.0000000000002547 · Cited by 9
"Estrogens and the Heart: Do they Help or Hurt?" How Estrogen impacts the Cardiovascular System
Modena, M. G. (2016) · SOJ Gynecology Obstetrics and Women s Health · doi:10.15226/2381-2915/2/1/00108 · Cited by 7
Differential Effects of Progestogens Used for Menopausal Hormone Therapy
Heertum, K. V., & LIU, J. H. (2018) · Clinical Obstetrics & Gynecology · doi:10.1097/grf.0000000000000364 · Cited by 9
Sriprasert, I., Mack, W. J., Hodis, H. N., Allayee, H., Brinton, R. D., & Karim, R. (2019) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2019.06.022 · Cited by 9
Kaminski, J., Mesa, C. O., Pavesi, H., Drobrzenski, B., & Amaral, G. D. (2021) · Menopause The Journal of The North American Menopause Society · doi:10.1097/gme.0000000000001811 · Cited by 10
“In addition, the ELITE trial showed that oral estradiol 1 mg led to LDL cholesterol levels that were significantly lower, while HDL and total triglyceride levels were significantly higher than the lipid profile in the placebo group.(35) There is a paucity of data comparing the effects of different progestogens on the…”
BackgroundWickham, K. A., Nørregaard, L. B., Oxfeldt, M., Cheung, S. S., Gliemann, L., Hansen, M., & Hellsten, Y. (2022) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2022.826959 · Cited by 9
“Specifically, it appears that HRT may not be an effective strategy for mitigating cardiovascular disease development if started late into menopause (15, 16).”
BackgroundA conversation about hormone therapy: is there an appropriate dose, route, and duration of use?
(2017) · Menopause The Journal of The North American Menopause Society · doi:10.1097/gme.0000000000000986 · Cited by 10
Counseling on hormone replacement therapy: the real risks and benefits
Voedisch, A. J. (2023) · Current Opinion in Obstetrics & Gynecology · doi:10.1097/gco.0000000000000843 · Cited by 8
Aslanyan, V., Pa, J., Hodis, H. N., John, J. S., Kono, N., Henderson, V. W., Mack, W. J., & Initiative, A. D. N. (2023) · Alzheimer s & Dementia Diagnosis Assessment & Disease Monitoring · doi:10.1002/dad2.12417 · Cited by 8
Marková, I., Hüttl, M., Miklánková, D., Šedová, L., Šeda, O., & Malínská, H. (2024) · Antioxidants · doi:10.3390/antiox13060627 · Cited by 13
“In a number of trials and prospective studies, hormone replacement therapy increased plasma TG levels, despite improvement in a number of risk factors for CVD [37–41].”
BackgroundArayıcı, M. E., Kılıç, M. E., & Yılmaz, M. B. (2024) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.70029 · Cited by 8
“This inconsistency has led to the development of the “timing hypothesis,” suggesting that the cardiovascular impact of HRT could depend on when treatment is initiated relative to the onset of menopause [12– 14].”
Improving Cardiovascular Clinical Competencies for the Menopausal Transition
Dastmalchi, L. N., Gulati, M., Thurston, R. C., Lau, E. S., Sarma, A. A., Marfori, C. Q., Gaffey, A. E., Faubion, S. S., Laddu, D., SHUFELT, C. L., et al. (2025) · JACC Advances · doi:10.1016/j.jacadv.2025.101791 · Cited by 9
Elimination of the Black Box Warning on Menopausal Hormone Therapy
Sriprasert, I., Hodis, H. N., Mack, W. J., Rosser, M. L., Evans, M. L., Xu, X., & Wright, J. D. (2026) · Obstetrics and Gynecology · doi:10.1097/aog.0000000000006226 · Cited by 8
Kim, J. H., & Lee, S. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms23147521 · Cited by 9
“Estrogen deficiency due to menopause has diverse implications, including a decline in dermal collagen content [15], cardiovascular deterioration [16], hair loss [17], nervous system imbalances [18], and loss of bone density [19,20].”
BackgroundThe emerging role of estrogen's non-nuclear signaling in the cardiovascular disease
Tokiwa, H., Ueda, K., & Takimoto, E. (2023) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2023.1127340 · Cited by 8
“Additionally, oral estradiol administration suppressed carotid artery atherosclerosis when treatment was initiated within six years, but not ten or more years after menopause (10).”
BackgroundTsai, W.-H., Sung, F., Muo, C., Tsai, M.-C., & Wu, S. (2023) · Frontiers in Pharmacology · doi:10.3389/fphar.2023.1220174 · Cited by 8
“A previous review showed that low-dose oral and transdermal HRT appears to be safe regarding the CVD risk in women within the fi rst 10 years after menopause (Grodstein et al., 2006; Hodis et al., 2016), which may be ages 45 – 60.”
BackgroundAssociation between triglyceride glucose index and H-type hypertension in postmenopausal women
Ding, Z., Du, S., Yang, Y., Yu, T., & Hong, X. (2023) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2023.1224296 · Cited by 8
Update on specificities of stroke in women
Christensen, H., Bentsen, L., & Christensen, L. M. (2016) · La Presse Médicale · doi:10.1016/j.lpm.2016.10.005 · Cited by 9
“Less progression in carotid artery intima media thickness was observed in the early group; no effects on measures related to heart CT were observed [48].”
Sriprasert, I., Hodis, H. N., Bernick, B. A., Mirkin, S., & Mack, W. J. (2020) · Climacteric · doi:10.1080/13697137.2019.1703939 · Cited by 8
Jordan, J. H., D’Agostino, R. B., Ansley, K. C., Douglas, E. H., Melin, S. A., Sorscher, S. M., Vasu, S., Park, S., Kotak, A., Romitti, P. A., et al. (2021) · JNCI Cancer Spectrum · doi:10.1093/jncics/pkab071 · Cited by 9
“These events may not become clinically apparent for years, at which point irreversible injury may have occurred (16).”
BackgroundTamer, S. A., Altınoluk, T., Emran, M., Korkmaz, S., Yüksel, R. G., Baykal, Z., Dur, Z. S., Levent, H. N., Ural, M., Yüksel, M., et al. (2022) · Inflammation · doi:10.1007/s10753-022-01685-2 · Cited by 8
“Although estrogen supplementation in OVX rats [51–55] or in younger postmenopausal women [56] was shown to be effective in delaying atherosclerosis and reducing the CVD risk [57, 58], randomized controlled trials were not able to confirm the CVD-preventive effect of postmenopausal hormone therapy alone [13].”
MethodEffects of obesogenic diet and estradiol on dorsal raphe gene expression in old female macaques
Bethea, C. L., Mueller, K., Reddy, A. P., Kohama, S. G., & Urbanski, H. F. (2017) · PLoS ONE · doi:10.1371/journal.pone.0178788 · Cited by 8
Cerebral Circulation in Men and Women
Memon, A., & McCullough, L. D. (2018) · Advances in experimental medicine and biology · doi:10.1007/978-3-319-77932-4_18 · Cited by 8
Management of Menopause and the Role For Hormone Therapy
Pinkerton, J. V., Conner, E. A., & Kaunitz, A. M. (2019) · Clinical Obstetrics & Gynecology · doi:10.1097/grf.0000000000000487 · Cited by 8
Nabulsi, L., Lawrence, K. E., Santhalingam, V., Abaryan, Z., Boyle, C. P., Villalón‐Reina, J. E., Nir, T. M., Gari, I. B., Zhu, A. H., Haddad, E., et al. (2020) · International Symposium on Medical Information Processing and Analysis (SIPAIM) · doi:10.1117/12.2579631 · Cited by 8
“The ELITE study (randomized double-blind placebo-controlled study; Hodis et al., 2016) also indicated that women prescribed HT (oral 17β-estradiol) much later (>10 years after menopause) may be at higher risk of AD, as opposed to commencing therapy within 6 years after menopause.”
BackgroundMethodA current perspective into young female sex hormone replacement: a review
Giordano Imbroll, M., & Gruppetta, M. (2020) · Expert Review of Endocrinology & Metabolism · doi:10.1080/17446651.2020.1816820 · Cited by 7
Helper T cells: A potential target for sex hormones to ameliorate rheumatoid arthritis? (Review)
Niu, Q., Hao, J., Li, Z., & Zhang, H. (2024) · Molecular Medicine Reports · doi:10.3892/mmr.2024.13339 · Cited by 6
“…development and disease activity of RA, with any number of births being significantly associated with a reduced risk of RA, but no such protective effect was found in nulliparous women (165), which, as previously described, is perhaps associated with high estrogen and Pg concentra‑ tions (166,167).”
BackgroundThen and Now: What We Have Learned From the WHI
Lambrinoudaki, I. V., Armeni, E., Mili, N., & Anagnostis, P. G. (2025) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgaf638 · Cited by 8
Metadata
- 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)
- 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
- 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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