Contributions of the Women’s Health Initiative to Cardiovascular Research
Michael J. LaMonteJoAnn E. MansonGarnet L. AndersonLaura D. BakerJennifer W. BeaCharles B. EatonShawna FollisKathleen M. HaydenCharles KooperbergAndrea Z. LaCroixMarian C. LimacherMarian L. NeuhouserAndrew OdegaardMarco PérezRoss L. PrenticeAlex P. ReinerMarcia L. StefanickLinda Van HornGretchen WellsEric A. WhitselJacques E. Rossouw
Key result
Menopausal hormone therapy shows no routine cardiovascular prevention benefit, confirms WHI review.
- n=161,808
Structured PICO
P
Population
161,808 diverse postmenopausal women aged 50-79 enrolled across 40 US centers to evaluate multiple clinical interventions and observational factors for chronic disease prevention.
I
Intervention
Multiple interventions and exposures evaluated across study arms, including menopausal hormone therapy (conjugated equine estrogens [CEE] 0.625 mg/d alone or with medroxyprogesterone acetate [MPA] 2.5 mg/d), low-fat dietary modification, calcium/vitamin D supplementation, and observational factors like physical activity, sleep, and body composition.
C
Comparator
Placebo for the hormone therapy trials; usual diet for the dietary modification trial; and internal comparative exposure groups for the observational cohorts.
O
Outcome
Primary prevention of major chronic diseases, including cardiovascular disease (CVD), coronary heart disease (CHD), breast cancer, colorectal cancer, and osteoporosis/hip fracture, depending on the specific trial arm.hard clinical
The Women's Health Initiative fundamentally transformed the understanding of postmenopausal cardiovascular health, most notably by demonstrating that routine menopausal hormone therapy does not prevent, and may actually increase, the risk of cardiovascular events in older women.
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“WHI is the largest investigation of women's health, including cardiovascular health, ever conducted in a national cohort of older postmenopausal women recruited from the community setting.”
“The pendulum has swung from chronic disease prevention to the more appropriate place of HT reserved for the treatment of menopausal symptoms. There's an improved understanding of the different balance of benefits and risks when HT is used for short-term symptom management vs. long-term disease prevention.”
“Heart disease is complex, and the effect of estrogen on one risk factor does not adequately predict the risk of having a heart attack. But this study offers some reassurance for women of menopausal age that it's not unsafe, in terms of the risk of heart attack, to take estrogen, at least for a few years.”
Implication
Reinforces guideline-directed avoidance of menopausal hormone therapy; leaves open further study of cardiovascular resiliency in aging women.
Abstract
The Women’s Health Initiative (WHI) enrolled 161,808 racially and ethnically diverse postmenopausal women, aged 50–79 years, from 1993 to 1998 at 40 clinical centers across the U.S. In its clinical trial component, WHI evaluated three randomized interventions (menopausal hormone therapy; diet modification; and calcium/vitamin D supplementation) for the primary prevention of major chronic diseases, including cardiovascular disease (CVD), in older women. In the WHI observational study, numerous clinical, behavioral, and social factors have been evaluated as predictors of incident chronic disease and mortality. Although the original interventions have been completed, the WHI data and biomarker resources continue to be leveraged and expanded through ancillary studies to yield novel insights regarding CVD prevention and healthy aging in women.
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Cite This Study
LaMonte et al. (2022) conducted a review in Cardiovascular disease (n=161,808). Menopausal hormone therapy, diet modification, and calcium/vitamin D supplementation vs. Placebo or unexposed was evaluated on Cardiovascular disease and major chronic diseases. The Women's Health Initiative established that menopausal hormone therapy is not recommended for routine cardiovascular disease prevention and generated extensive ongoing insights into healthy aging.