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. 2023 Jun 16;108(8):1835–1874. doi: 10.1210/clinem/dgad225

Table 2.

Randomized primary prevention trials evaluating effects of menopausal hormone therapy on clinical and surrogate cardiovascular outcomes in healthy, recently postmenopausal women

Trial MHT preparation and dose N Age (y) Duration (y) Outcomes
Clinical outcomes
WHI E-alone (117) CEE 0.625 mg/d po 3313 50-59 7.2 Reduced MI, CAC, and revascularization
WHI E + P (117) CEE 0.625 mg/d and MPA 2.5 mg/d po 5520 50-59 5.6 No benefit
DOPS (134) 17-B E2 2 mg/day and norethisterone acetate 1 mg 10 days/mo po 1006 45-58 10 Reduced composite serious adverse events: death, hospitalized MI, or CHF
Surrogate outcomes
KEEPS (135) CEE 0.45 mg/d po or TD E2 50 mcg and progesterone 200 mg 12 days/mo po 727 42-58 4 No benefit cIMT or CAC
ELITE (136) 17-B E2 1 mg/d po and progesterone 45 mg vaginal gel 10 days/mo 596 55-64 5 Reduced cIMT early group
No benefit CAC

Early <6 years since menopause vs late ≥10 years since menopause.

Abbreviations: CAC, coronary artery calcium; CEE, conjugated equine estrogens; CHF, congestive heart failure; cIMT, carotid intima-medial thickness; DOPS, Danish Osteoporosis Prevention Study (randomized, not blinded); E2, estradiol; E-alone, estrogen alone trial; E + P, estrogen plus progestogen; ELITE, Early vs Late Postmenopausal Treatment with Estradiol; KEEPS, Kronos Early Estrogen Prevention Study; MHT, menopausal hormone therapy; MI, myocardial infarction; MPA, medroxyprogesterone acetate; po, oral; TD, transdermal; WHI, Women's Health Initiative; y, years.