title: Arterial imaging outcomes and cardiovascular risk factors in recently menopausal women: a randomized trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  Randomized, controlled trial. (ClinicalTrials.gov: NCT00154180).
  
  
  METHODS
  Nine U.S. academic centers.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Power to compare clinical events was insufficient.
  
  
  CONCLUSIONS
  Four years of early MHT did not affect progression of atherosclerosis despite improving some markers of CVD risk.
  
  
  BACKGROUND
  Aurora Foundation.
authors: S Mitchell
authors: SM
authors: Harman
authors: Dennis M
authors: DM
authors: Black
authors: Frederick
authors: F
authors: Naftolin
authors: Eliot A
authors: EA
authors: Brinton
authors: Matthew J
authors: MJ
authors: Budoff
authors: Marcelle I
authors: MI
authors: Cedars
authors: Paul N
authors: PN
authors: Hopkins
authors: Rogerio A
authors: RA
authors: Lobo
authors: JoAnn E
authors: JE
authors: Manson
authors: George R
authors: GR
authors: Merriam
authors: Virginia M
authors: VM
authors: Miller
authors: Genevieve
authors: G
authors: Neal-Perry
authors: Nanette
authors: N
authors: Santoro
authors: Hugh S
authors: HS
authors: Taylor
authors: Eric
authors: E
authors: Vittinghoff
authors: Mingzhu
authors: M
authors: Yan
authors: Howard N
authors: HN
authors: Hodis
mesh_terms: D000279:Administration, Cutaneous; D000284:Administration, Oral; D000328:Adult; D002097:C-Reactive Protein / Q000378:metabolism; D059168:Carotid Intima-Media Thickness; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000517:prevention & control*; D018450:Disease Progression; D004311:Double-Blind Method; D004958:Estradiol / Q000009:adverse effects / Q000627:therapeutic use; D015914:Estrogen Replacement Therapy / Q000009:adverse effects; D004967:Estrogens / Q000097:blood; D004966:Estrogens, Conjugated (USP) / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007333:Insulin Resistance; D008055:Lipids / Q000097:blood; D008875:Middle Aged; D017698:Postmenopause / Q000187:drug effects / Q000502:physiology*; D011374:Progesterone / Q000627:therapeutic use; D011859:Radiography; D012307:Risk Factors; D012738:Sex Hormone-Binding Globulin / Q000378:metabolism
chemical_list: D004967:Estrogens; D004966:Estrogens, Conjugated (USP); D008055:Lipids; D012738:Sex Hormone-Binding Globulin; D011374:Progesterone; D004958:Estradiol; D002097:C-Reactive Protein