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The Kronos Early Estrogen Prevention Study (KEEPS): what have we learned?

OBJECTIVE:The Kronos Early Estrogen Prevention Study (KEEPS) was designed to address gaps in understanding the effects of timely menopausal hormone treatments (HT) on cardiovascular health and other effects of menopause after the premature termination of the Womenʼs Health Initiative. METHOD:The KEE... Full description

Journal Title: Menopause (New York N.Y.), 2019-09, Vol.26 (9), p.1071-1084
Main Author: Miller, Virginia M
Other Authors: Naftolin, Fredrick , Asthana, Sanjay , Black, Dennis M , Brinton, Eliot A , Budoff, Matthew J , Cedars, Marcelle I , Dowling, N Maritza , Gleason, Carey E , Hodis, Howard N , Jayachandran, Muthuvel , Kantarci, Kejal , Lobo, Rogerio A , Manson, JoAnn E , Pal, Lubna , Santoro, Nanette F , Taylor, Hugh S , Harman, S Mitchell
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: United States: by The North American Menopause Society
ID: ISSN: 1072-3714
Link: https://www.ncbi.nlm.nih.gov/pubmed/31453973
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recordid: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6738629
title: The Kronos Early Estrogen Prevention Study (KEEPS): what have we learned?
format: Article
creator:
  • Miller, Virginia M
  • Naftolin, Fredrick
  • Asthana, Sanjay
  • Black, Dennis M
  • Brinton, Eliot A
  • Budoff, Matthew J
  • Cedars, Marcelle I
  • Dowling, N Maritza
  • Gleason, Carey E
  • Hodis, Howard N
  • Jayachandran, Muthuvel
  • Kantarci, Kejal
  • Lobo, Rogerio A
  • Manson, JoAnn E
  • Pal, Lubna
  • Santoro, Nanette F
  • Taylor, Hugh S
  • Harman, S Mitchell
subjects:
  • Analysis
  • Cardiovascular disease
  • Carotid Intima-Media Thickness
  • Clinical trials
  • Cognition
  • Coronary Artery Disease - physiopathology
  • Coronary Artery Disease - prevention & control
  • Estrogen
  • Estrogen Replacement Therapy
  • Female
  • Health aspects
  • Health Sciences
  • Hormone therapy
  • Humans
  • Medical
  • Menopausal symptoms
  • Menopause
  • Middle Aged
  • Obstetrics & Reproductive Medicine
  • Osteoporosis
  • Postmenopausal women
  • Randomized Controlled Trials as Topic
  • Review
  • Review Article
  • Safety and security measures
  • Usage
ispartof: Menopause (New York, N.Y.), 2019-09, Vol.26 (9), p.1071-1084
description: OBJECTIVE:The Kronos Early Estrogen Prevention Study (KEEPS) was designed to address gaps in understanding the effects of timely menopausal hormone treatments (HT) on cardiovascular health and other effects of menopause after the premature termination of the Womenʼs Health Initiative. METHOD:The KEEPS was a randomized, double-blinded, placebo-controlled trial to test the hypothesis that initiation of HT (oral conjugated equine estrogens [o-CEE] or transdermal 17β-estradiol [t-E2]) in healthy, recently postmenopausal women (n = 727) would slow the progression of atherosclerosis as measured by changes in carotid artery intima-media thickness (CIMT). RESULTS:After 4 years, neither HT affected the rate of increase in CIMT. There was a trend for reduced accumulation of coronary artery calcium with o-CEE. There were no severe adverse effects, including venous thrombosis. Several ancillary studies demonstrated a positive effect on mood with o-CEE, and reduced hot flashes, improved sleep, and maintenance of bone mineral density with both treatments. Sexual function improved with t-E2. There were no significant effects of either treatment on cognition, breast pain, or skin wrinkling. Variants of genes associated with estrogen metabolism influenced the age of menopause and variability in effects of the HT on CIMT. Platelet activation associated with the development of white matter hyperintensities in the brain. CONCLUSIONS:KEEPS and its ancillary studies have supported the value and safety of the use of HT in recently postmenopausal women and provide a perspective for future research to optimize HT and health of postmenopausal women. The KEEPS continuation study continues to pursue these issues.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 1072-3714
fulltext: fulltext
issn:
  • 1072-3714
  • 1530-0374
url: Link


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titleThe Kronos Early Estrogen Prevention Study (KEEPS): what have we learned?
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creatorMiller, Virginia M ; Naftolin, Fredrick ; Asthana, Sanjay ; Black, Dennis M ; Brinton, Eliot A ; Budoff, Matthew J ; Cedars, Marcelle I ; Dowling, N Maritza ; Gleason, Carey E ; Hodis, Howard N ; Jayachandran, Muthuvel ; Kantarci, Kejal ; Lobo, Rogerio A ; Manson, JoAnn E ; Pal, Lubna ; Santoro, Nanette F ; Taylor, Hugh S ; Harman, S Mitchell
creatorcontribMiller, Virginia M ; Naftolin, Fredrick ; Asthana, Sanjay ; Black, Dennis M ; Brinton, Eliot A ; Budoff, Matthew J ; Cedars, Marcelle I ; Dowling, N Maritza ; Gleason, Carey E ; Hodis, Howard N ; Jayachandran, Muthuvel ; Kantarci, Kejal ; Lobo, Rogerio A ; Manson, JoAnn E ; Pal, Lubna ; Santoro, Nanette F ; Taylor, Hugh S ; Harman, S Mitchell
descriptionOBJECTIVE:The Kronos Early Estrogen Prevention Study (KEEPS) was designed to address gaps in understanding the effects of timely menopausal hormone treatments (HT) on cardiovascular health and other effects of menopause after the premature termination of the Womenʼs Health Initiative. METHOD:The KEEPS was a randomized, double-blinded, placebo-controlled trial to test the hypothesis that initiation of HT (oral conjugated equine estrogens [o-CEE] or transdermal 17β-estradiol [t-E2]) in healthy, recently postmenopausal women (n = 727) would slow the progression of atherosclerosis as measured by changes in carotid artery intima-media thickness (CIMT). RESULTS:After 4 years, neither HT affected the rate of increase in CIMT. There was a trend for reduced accumulation of coronary artery calcium with o-CEE. There were no severe adverse effects, including venous thrombosis. Several ancillary studies demonstrated a positive effect on mood with o-CEE, and reduced hot flashes, improved sleep, and maintenance of bone mineral density with both treatments. Sexual function improved with t-E2. There were no significant effects of either treatment on cognition, breast pain, or skin wrinkling. Variants of genes associated with estrogen metabolism influenced the age of menopause and variability in effects of the HT on CIMT. Platelet activation associated with the development of white matter hyperintensities in the brain. CONCLUSIONS:KEEPS and its ancillary studies have supported the value and safety of the use of HT in recently postmenopausal women and provide a perspective for future research to optimize HT and health of postmenopausal women. The KEEPS continuation study continues to pursue these issues.
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subjectAnalysis ; Cardiovascular disease ; Carotid Intima-Media Thickness ; Clinical trials ; Cognition ; Coronary Artery Disease - physiopathology ; Coronary Artery Disease - prevention & control ; Estrogen ; Estrogen Replacement Therapy ; Female ; Health aspects ; Health Sciences ; Hormone therapy ; Humans ; Medical ; Menopausal symptoms ; Menopause ; Middle Aged ; Obstetrics & Reproductive Medicine ; Osteoporosis ; Postmenopausal women ; Randomized Controlled Trials as Topic ; Review ; Review Article ; Safety and security measures ; Usage
ispartofMenopause (New York, N.Y.), 2019-09, Vol.26 (9), p.1071-1084
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1Naftolin, Fredrick
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8Gleason, Carey E
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11Kantarci, Kejal
12Lobo, Rogerio A
13Manson, JoAnn E
14Pal, Lubna
15Santoro, Nanette F
16Taylor, Hugh S
17Harman, S Mitchell
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descriptionOBJECTIVE:The Kronos Early Estrogen Prevention Study (KEEPS) was designed to address gaps in understanding the effects of timely menopausal hormone treatments (HT) on cardiovascular health and other effects of menopause after the premature termination of the Womenʼs Health Initiative. METHOD:The KEEPS was a randomized, double-blinded, placebo-controlled trial to test the hypothesis that initiation of HT (oral conjugated equine estrogens [o-CEE] or transdermal 17β-estradiol [t-E2]) in healthy, recently postmenopausal women (n = 727) would slow the progression of atherosclerosis as measured by changes in carotid artery intima-media thickness (CIMT). RESULTS:After 4 years, neither HT affected the rate of increase in CIMT. There was a trend for reduced accumulation of coronary artery calcium with o-CEE. There were no severe adverse effects, including venous thrombosis. Several ancillary studies demonstrated a positive effect on mood with o-CEE, and reduced hot flashes, improved sleep, and maintenance of bone mineral density with both treatments. Sexual function improved with t-E2. There were no significant effects of either treatment on cognition, breast pain, or skin wrinkling. Variants of genes associated with estrogen metabolism influenced the age of menopause and variability in effects of the HT on CIMT. Platelet activation associated with the development of white matter hyperintensities in the brain. CONCLUSIONS:KEEPS and its ancillary studies have supported the value and safety of the use of HT in recently postmenopausal women and provide a perspective for future research to optimize HT and health of postmenopausal women. The KEEPS continuation study continues to pursue these issues.
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1Cardiovascular disease
2Carotid Intima-Media Thickness
3Clinical trials
4Cognition
5Coronary Artery Disease - physiopathology
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7Estrogen
8Estrogen Replacement Therapy
9Female
10Health aspects
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14Medical
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17Middle Aged
18Obstetrics & Reproductive Medicine
19Osteoporosis
20Postmenopausal women
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titleThe Kronos Early Estrogen Prevention Study (KEEPS): what have we learned?
authorMiller, Virginia M ; Naftolin, Fredrick ; Asthana, Sanjay ; Black, Dennis M ; Brinton, Eliot A ; Budoff, Matthew J ; Cedars, Marcelle I ; Dowling, N Maritza ; Gleason, Carey E ; Hodis, Howard N ; Jayachandran, Muthuvel ; Kantarci, Kejal ; Lobo, Rogerio A ; Manson, JoAnn E ; Pal, Lubna ; Santoro, Nanette F ; Taylor, Hugh S ; Harman, S Mitchell
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7Estrogen
8Estrogen Replacement Therapy
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9Hodis, Howard N
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13Manson, JoAnn E
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8Gleason, Carey E
9Hodis, Howard N
10Jayachandran, Muthuvel
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14Pal, Lubna
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abstractOBJECTIVE:The Kronos Early Estrogen Prevention Study (KEEPS) was designed to address gaps in understanding the effects of timely menopausal hormone treatments (HT) on cardiovascular health and other effects of menopause after the premature termination of the Womenʼs Health Initiative. METHOD:The KEEPS was a randomized, double-blinded, placebo-controlled trial to test the hypothesis that initiation of HT (oral conjugated equine estrogens [o-CEE] or transdermal 17β-estradiol [t-E2]) in healthy, recently postmenopausal women (n = 727) would slow the progression of atherosclerosis as measured by changes in carotid artery intima-media thickness (CIMT). RESULTS:After 4 years, neither HT affected the rate of increase in CIMT. There was a trend for reduced accumulation of coronary artery calcium with o-CEE. There were no severe adverse effects, including venous thrombosis. Several ancillary studies demonstrated a positive effect on mood with o-CEE, and reduced hot flashes, improved sleep, and maintenance of bone mineral density with both treatments. Sexual function improved with t-E2. There were no significant effects of either treatment on cognition, breast pain, or skin wrinkling. Variants of genes associated with estrogen metabolism influenced the age of menopause and variability in effects of the HT on CIMT. Platelet activation associated with the development of white matter hyperintensities in the brain. CONCLUSIONS:KEEPS and its ancillary studies have supported the value and safety of the use of HT in recently postmenopausal women and provide a perspective for future research to optimize HT and health of postmenopausal women. The KEEPS continuation study continues to pursue these issues.
copUnited States
pubby The North American Menopause Society
pmid31453973
doi10.1097/GME.0000000000001326
oafree_for_read