Arterial imaging outcomes and cardiovascular risk factors in recently menopausal women: A randomized trial

S. Mitchell Harman, Dennis M. Black, Frederick Naftolin, Eliot A. Brinton, Matthew J. Budoff, Marcelle I. Cedars, Paul N. Hopkins, Rogerio A. Lobo, Joann E. Manson, George R. Merriam, Virginia M Miller, Genevieve Neal-Perry, Nanette Santoro, Hugh S. Taylor, Eric Vittinghoff, Mingzhu Yan, Howard N. Hodis

Research output: Contribution to journalArticle

163 Citations (Scopus)

Abstract

Whether menopausal hormone therapy (MHT) protects against cardiovascular disease (CVD) remains unclear. Objective: To assess atherosclerosis progression and CVD risk factors after MHT initiated in early menopause. Design: Randomized, controlled trial. (ClinicalTrials.gov: NCT00154180) Setting: Nine U.S. academic centers. Participants: Healthy menopausal women aged 42 to 58 years between 6 and 36 months from last menses without prior CVD events who had a coronary artery calcium (CAC) score less than 50 Agatston units and had not received estrogen or lipid-lowering therapy for at least 90 days. Intervention: Oral conjugated equine estrogens (o-CEE), 0.45 mg/d, or transdermal 17β-estradiol (t-E2), 50 mcg/d, each with 200 mg of oral progesterone for 12 days per month, or placebo for 48 months. Measurements: Primary end point was annual change in carotid artery intima-media thickness (CIMT). Secondary end points included changes in markers of CVD risk. Results: Of 727 randomly assigned women, 89.3% had at least 1 follow-up CIMT and 79.8% had CIMT at 48 months. Mean CIMT increases of 0.007 mm/y were similar across groups. The percentages of participants in whom CAC score increased did not differ significantly across groups. No changes in blood pressure were observed with o-CEE or t-E2. Low- and high-density lipoprotein cholesterol levels improved and levels of C-reactive protein and sex hormone-binding globulin but not interleukin-6 increased with o-CEE. Insulin resistance decreased with t-E2. Serious adverse events did not differ by treatment. Limitation: Power to compare clinical events was insufficient. Conclusion: Four years of early MHT did not affect progression of atherosclerosis despite improving some markers of CVD risk.

Original languageEnglish (US)
Pages (from-to)249-260
Number of pages12
JournalAnnals of Internal Medicine
Volume161
Issue number4
DOIs
StatePublished - Aug 19 2014

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Carotid Intima-Media Thickness
Cardiovascular Diseases
Carotid Arteries
Conjugated (USP) Estrogens
Hormones
Atherosclerosis
Coronary Vessels
Calcium
Therapeutics
Sex Hormone-Binding Globulin
Menstruation
Menopause
C-Reactive Protein
HDL Cholesterol
Progesterone
Insulin Resistance
Estradiol
Interleukin-6
Healthy Volunteers
Estrogens

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Harman, S. M., Black, D. M., Naftolin, F., Brinton, E. A., Budoff, M. J., Cedars, M. I., ... Hodis, H. N. (2014). Arterial imaging outcomes and cardiovascular risk factors in recently menopausal women: A randomized trial. Annals of Internal Medicine, 161(4), 249-260. https://doi.org/10.7326/M14-0353

Arterial imaging outcomes and cardiovascular risk factors in recently menopausal women : A randomized trial. / Harman, S. Mitchell; Black, Dennis M.; Naftolin, Frederick; Brinton, Eliot A.; Budoff, Matthew J.; Cedars, Marcelle I.; Hopkins, Paul N.; Lobo, Rogerio A.; Manson, Joann E.; Merriam, George R.; Miller, Virginia M; Neal-Perry, Genevieve; Santoro, Nanette; Taylor, Hugh S.; Vittinghoff, Eric; Yan, Mingzhu; Hodis, Howard N.

In: Annals of Internal Medicine, Vol. 161, No. 4, 19.08.2014, p. 249-260.

Research output: Contribution to journalArticle

Harman, SM, Black, DM, Naftolin, F, Brinton, EA, Budoff, MJ, Cedars, MI, Hopkins, PN, Lobo, RA, Manson, JE, Merriam, GR, Miller, VM, Neal-Perry, G, Santoro, N, Taylor, HS, Vittinghoff, E, Yan, M & Hodis, HN 2014, 'Arterial imaging outcomes and cardiovascular risk factors in recently menopausal women: A randomized trial', Annals of Internal Medicine, vol. 161, no. 4, pp. 249-260. https://doi.org/10.7326/M14-0353
Harman, S. Mitchell ; Black, Dennis M. ; Naftolin, Frederick ; Brinton, Eliot A. ; Budoff, Matthew J. ; Cedars, Marcelle I. ; Hopkins, Paul N. ; Lobo, Rogerio A. ; Manson, Joann E. ; Merriam, George R. ; Miller, Virginia M ; Neal-Perry, Genevieve ; Santoro, Nanette ; Taylor, Hugh S. ; Vittinghoff, Eric ; Yan, Mingzhu ; Hodis, Howard N. / Arterial imaging outcomes and cardiovascular risk factors in recently menopausal women : A randomized trial. In: Annals of Internal Medicine. 2014 ; Vol. 161, No. 4. pp. 249-260.
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abstract = "Whether menopausal hormone therapy (MHT) protects against cardiovascular disease (CVD) remains unclear. Objective: To assess atherosclerosis progression and CVD risk factors after MHT initiated in early menopause. Design: Randomized, controlled trial. (ClinicalTrials.gov: NCT00154180) Setting: Nine U.S. academic centers. Participants: Healthy menopausal women aged 42 to 58 years between 6 and 36 months from last menses without prior CVD events who had a coronary artery calcium (CAC) score less than 50 Agatston units and had not received estrogen or lipid-lowering therapy for at least 90 days. Intervention: Oral conjugated equine estrogens (o-CEE), 0.45 mg/d, or transdermal 17β-estradiol (t-E2), 50 mcg/d, each with 200 mg of oral progesterone for 12 days per month, or placebo for 48 months. Measurements: Primary end point was annual change in carotid artery intima-media thickness (CIMT). Secondary end points included changes in markers of CVD risk. Results: Of 727 randomly assigned women, 89.3{\%} had at least 1 follow-up CIMT and 79.8{\%} had CIMT at 48 months. Mean CIMT increases of 0.007 mm/y were similar across groups. The percentages of participants in whom CAC score increased did not differ significantly across groups. No changes in blood pressure were observed with o-CEE or t-E2. Low- and high-density lipoprotein cholesterol levels improved and levels of C-reactive protein and sex hormone-binding globulin but not interleukin-6 increased with o-CEE. Insulin resistance decreased with t-E2. Serious adverse events did not differ by treatment. Limitation: Power to compare clinical events was insufficient. Conclusion: Four years of early MHT did not affect progression of atherosclerosis despite improving some markers of CVD risk.",
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AU - Harman, S. Mitchell

AU - Black, Dennis M.

AU - Naftolin, Frederick

AU - Brinton, Eliot A.

AU - Budoff, Matthew J.

AU - Cedars, Marcelle I.

AU - Hopkins, Paul N.

AU - Lobo, Rogerio A.

AU - Manson, Joann E.

AU - Merriam, George R.

AU - Miller, Virginia M

AU - Neal-Perry, Genevieve

AU - Santoro, Nanette

AU - Taylor, Hugh S.

AU - Vittinghoff, Eric

AU - Yan, Mingzhu

AU - Hodis, Howard N.

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N2 - Whether menopausal hormone therapy (MHT) protects against cardiovascular disease (CVD) remains unclear. Objective: To assess atherosclerosis progression and CVD risk factors after MHT initiated in early menopause. Design: Randomized, controlled trial. (ClinicalTrials.gov: NCT00154180) Setting: Nine U.S. academic centers. Participants: Healthy menopausal women aged 42 to 58 years between 6 and 36 months from last menses without prior CVD events who had a coronary artery calcium (CAC) score less than 50 Agatston units and had not received estrogen or lipid-lowering therapy for at least 90 days. Intervention: Oral conjugated equine estrogens (o-CEE), 0.45 mg/d, or transdermal 17β-estradiol (t-E2), 50 mcg/d, each with 200 mg of oral progesterone for 12 days per month, or placebo for 48 months. Measurements: Primary end point was annual change in carotid artery intima-media thickness (CIMT). Secondary end points included changes in markers of CVD risk. Results: Of 727 randomly assigned women, 89.3% had at least 1 follow-up CIMT and 79.8% had CIMT at 48 months. Mean CIMT increases of 0.007 mm/y were similar across groups. The percentages of participants in whom CAC score increased did not differ significantly across groups. No changes in blood pressure were observed with o-CEE or t-E2. Low- and high-density lipoprotein cholesterol levels improved and levels of C-reactive protein and sex hormone-binding globulin but not interleukin-6 increased with o-CEE. Insulin resistance decreased with t-E2. Serious adverse events did not differ by treatment. Limitation: Power to compare clinical events was insufficient. Conclusion: Four years of early MHT did not affect progression of atherosclerosis despite improving some markers of CVD risk.

AB - Whether menopausal hormone therapy (MHT) protects against cardiovascular disease (CVD) remains unclear. Objective: To assess atherosclerosis progression and CVD risk factors after MHT initiated in early menopause. Design: Randomized, controlled trial. (ClinicalTrials.gov: NCT00154180) Setting: Nine U.S. academic centers. Participants: Healthy menopausal women aged 42 to 58 years between 6 and 36 months from last menses without prior CVD events who had a coronary artery calcium (CAC) score less than 50 Agatston units and had not received estrogen or lipid-lowering therapy for at least 90 days. Intervention: Oral conjugated equine estrogens (o-CEE), 0.45 mg/d, or transdermal 17β-estradiol (t-E2), 50 mcg/d, each with 200 mg of oral progesterone for 12 days per month, or placebo for 48 months. Measurements: Primary end point was annual change in carotid artery intima-media thickness (CIMT). Secondary end points included changes in markers of CVD risk. Results: Of 727 randomly assigned women, 89.3% had at least 1 follow-up CIMT and 79.8% had CIMT at 48 months. Mean CIMT increases of 0.007 mm/y were similar across groups. The percentages of participants in whom CAC score increased did not differ significantly across groups. No changes in blood pressure were observed with o-CEE or t-E2. Low- and high-density lipoprotein cholesterol levels improved and levels of C-reactive protein and sex hormone-binding globulin but not interleukin-6 increased with o-CEE. Insulin resistance decreased with t-E2. Serious adverse events did not differ by treatment. Limitation: Power to compare clinical events was insufficient. Conclusion: Four years of early MHT did not affect progression of atherosclerosis despite improving some markers of CVD risk.

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