6/30/23, 12:46 AM WHI Pathway Feedback Search Clinical Topics Home Studies WHI WHI Disease Disease Coronary artery disease Menopause Trial question What is the role of estrogen plus progestin in healthy postmenopausal women? Study design Multi-center Double blinded RCT Population 16608 female patients Inclusion criteria: healthy postmenopausal women aged 50-79 years with an intact uterus at baseline Key exclusion criteria: any medical condition likely to be associated with a predicted survival of < 3 years, prior breast cancer, other prior cancer within the last 10 years except nonmelanoma skin cancer, low hematocrit or platelet counts, alcoholism, or dementia Interventions N=8506 estrogen plus progestin (conjugated equine estrogens, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d, in 1 tablet) N=8102 placebo (matching placebo tablet) Primary outcome Nonfatal myocardial infarction or cardiovascular death 0.4 % 0.37 0.3 0.3 % 0.2 % 0.1 % Borderline significant increase 0.0 % Estrogen plus progestin Placebo https://web.pathway.md/studies/reczMy2U49X8YHk2C 1/2 6/30/23, 12:46 AM WHI Pathway Borderline significant increase in nonfatal myocardial infarction or cardiovascular death (0.37% vs. 0.3%; HR 1.29, 95% CI 1.02 to 1.63) Secondary outcomes No significant difference in stroke (0.29% vs. 0.21%; HR 1.41, 95% CI 0.81 to 1.07) Borderline significant increase in venous thromboembolic disease (0.34% vs. 0.16%; HR 2.11, 95% CI 1.58 to 2.82) Borderline significant decrease in osteoporotic fractures (1.47% vs. 1.91%; HR 0.76, 95% CI 0.69 to 0.85) Safety outcomes No significant difference in death and cause of death. Significant difference in invasive breast cancer (0.38% per year vs. 0.30% per year). Conclusion In healthy postmenopausal women aged 50-79 years with an intact uterus at baseline, estrogen plus progestin was inferior to placebo with respect to nonfatal myocardial infarction or cardiovascular death. Reference Rossouw JE, Anderson GL, Prentice RL et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33. Open reference URL https://web.pathway.md/studies/reczMy2U49X8YHk2C 2/2