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QUESTION: Does hormone therapy (HT) improve health-related quality of life (HRQL) in postmenopausal women with coronary artery disease (CAD)?
Design
Randomised {allocation concealed*}†, blinded {patients, clinicians, data collectors, and outcome assessors}‡*, placebo-controlled trial with follow up to 3 years.
Setting
Outpatient and community settings at 20 US clinical centres.
Patients
2763 postmenopausal women <80 years of age (mean age 67 y) with documented CAD (previous myocardial infarction [MI], >50% luminal narrowing of a major vessel on angiography, or a previous coronary revascularisation procedure). Exclusion criteria were MI or revascularisation procedure in the past 6 months, previous hysterectomy, contraindications to HT, HT in the previous 3 months, or life-threatening illness. 2762 patients (99.9%) were included in the analysis; 2246 (81%) had HRQL data for all time points (baseline, 4 mo, 1 y, and 3 y).
Intervention
1380 women were allocated to HT (0.625 mg of conjugated equine oestrogens and 2.5 mg of medroxyprogesterone acetate [Prempro, …