Can biomarkers identify women at increased stroke risk?
OBJECTIVE: The Women’s Health Initiative hormone trials identified a 44% increase in ischemic stroke risk with combination estrogen plus progestin and a 39% increase with estrogen alone. We undertook a case-control biomarker study to elucidate underlying mechanisms, and to potentially identify women who would be at lower or higher risk for stroke with postmenopausal hormone therapy (HT). DESIGN: The hormone trials were randomized, double-blind, and placebo controlled. SETTING: The Women’s Health Initiative trials were conducted at 40 clinical centers in the United States. PARTICIPANTS: The trials enrolled 27,347 postmenopausal women, aged 50-79 y. INTERVENTIONS: We randomized 16,608 women with intact uterus to conjugated estrogens 0.625 mg with medroxyprogesterone acetate 2.5 mg daily or placebo, and 10,739 women with prior hysterectomy to conjugated estrogens 0.625 mg daily or placebo. OUTCOME MEASURES: Stroke was ascertained during 5.6 y of follow-up in the estrogen plus progestin tr