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Hormone Replacement Therapy for Primary and Secondary Prevention of Heart Disease
Svati H. Shah1, Karen P. Alexander
1Duke University Medical Center, Cardiovascular Division, Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC 27710, USA. Alex019@mc.duke.edu
Insights
Hormone replacement therapy (HRT) does not prevent cardiovascular disease in women. Randomized trials show HRT increases risks for heart attack, stroke, blood clots, and breast cancer, and is not recommended for prevention.
Area of Science:
- Cardiovascular Medicine
- Endocrinology
- Women's Health
Background:
- Cardiovascular disease is the leading cause of mortality in women.
- Observational studies suggested hormone replacement therapy (HRT) reduced cardiovascular disease (CVD) risk.
- Conflicting evidence necessitated randomized trials to confirm HRT's role in CVD prevention.
Purpose of the Study:
- To evaluate the efficacy and safety of hormone replacement therapy (HRT) for primary and secondary prevention of cardiovascular disease (CVD) in women.
- To assess HRT's impact on major adverse cardiovascular events, including myocardial infarction, stroke, and venous thromboembolism.
- To determine HRT's effect on the progression of subclinical atherosclerosis and risk of gallbladder disease.
Main Methods:
- Pooled analysis of observational studies.
- Randomized controlled trials including the Heart and Estrogen/progestin Replacement Study (HERS) and the Women's Health Initiative (WHI).
- Assessment of cardiovascular events, stroke, venous thromboembolism (VTE), gallbladder disease, and breast cancer incidence.
Main Results:
- Randomized trials found no cardiovascular benefit from HRT for primary or secondary prevention.
- HRT, particularly estrogen plus progestin, increased risks of heart attack, stroke, and deep venous thrombosis/pulmonary embolism.
- HRT was associated with an increased risk of gallbladder disease and, with prolonged use, breast cancer.
Conclusions:
- HRT is not recommended for the primary or secondary prevention of cardiovascular disease or stroke in women.
- The risks associated with HRT outweigh potential benefits for CVD prevention.
- HRT may be considered for short-term menopausal symptom relief in select women, with alternatives available.
Abstract:
Cardiovascular disease is the leading cause of death in women. In pooled analysis, observational studies have shown a 50% reduction in death and myocardial infarction among users of hormone replacement therapy (HRT) for the primary and secondary prevention of cardiovascular disease. The first randomized trial of HRT for secondary prevention of heart disease found no benefit to therapy (Heart and Estrogen/progestin Replacement Study ). Even after 6.8 years of follow-up, there was still no cardiovascular benefit from the use of HRT (HERS II). HRT was associated with a 50% increased risk of heart attacks within the first year as well as an increased risk of deep venous thrombosis (DVT) and pulmonary embolism (PE) (relative risk 2.89) and gallbladder disease (RR 1.38). The Estrogen Replacement and Atherosclerosis trial found no evidence that HRT slowed the progression of subclinical angiographic disease either. This was despite a favorable effect on high-density lipoprotein and low-density lipoprotein. The first randomized trial of HRT for the primary prevention of heart disease found no overall benefit (Women's Health Initiative). The combination of estrogen and progestin resulted in a 29% increase in heart attacks, 41% increase in stroke, a doubling of thrombotic events (DVT and PE), as well as a 26% increase in breast cancer. The risk for thrombotic events was greatest in the first year whereas the risk of breast cancer increased progressively with duration of therapy. HRT is no longer recommended for the primary or secondary prevention of cardiovascular disease or stroke. It may still be considered for short-term relief of menopausal symptoms in women without high-risk conditions, but alternatives exist.