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Ann Intern Med. 2014 Aug 19;161(4):249-60. doi: 10.7326/M14-0353.

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.

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.

Comment in

PMID:
25069991
DOI:
10.7326/M14-0353
[Indexed for MEDLINE]

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