Arterial imaging outcomes and cardiovascular risk factors in recently menopausal women: a randomized trial
SM Harman, DM Black, F Naftolin… - Annals of internal …, 2014 - acpjournals.org
Annals of internal medicine, 2014•acpjournals.org
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. Design: Randomized, controlled
trial.(ClinicalTrials. gov: NCT00154180) Setting: Nine US 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 …
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 US 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 …
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.
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.
Primary Funding Source
Aurora Foundation.
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