FDA-Approved Indications for Hormone Replacement Therapy
To prevent heart disease is NOT an FDA-approved indication for hormone replacement therapy (HRT). 1
FDA-Approved Indications for HRT
The FDA has approved HRT for the following indications:
- Moderate to severe vasomotor symptoms (hot flashes, night sweats)
- Prevention of bone loss/osteoporosis in postmenopausal women
- Vaginal dryness (treatment of vulvar and vaginal atrophy)
Evidence Against HRT for Heart Disease Prevention
The U.S. Preventive Services Task Force (USPSTF) explicitly recommends against the routine use of estrogen and progestin for the prevention of chronic conditions in postmenopausal women, including heart disease 1. This recommendation is based on evidence showing:
- Increased risk of coronary heart disease (CHD) with HRT use (fair to good evidence)
- Increased risk of stroke with HRT use (fair evidence)
- Increased risk of venous thromboembolism with HRT use (good evidence)
The USPSTF concluded that "the harmful effects of estrogen and progestin are likely to exceed the chronic disease prevention benefits in most women" 1.
Women's Health Initiative (WHI) Findings
The Women's Health Initiative (WHI) trial, which is the largest randomized placebo-controlled trial on HRT, demonstrated that combined estrogen-progestin therapy was associated with:
- 7 additional CHD events per 10,000 women per year
- 8 more strokes per 10,000 women per year
- 8 more pulmonary emboli per 10,000 women per year 1
Evolving Understanding of HRT and Heart Disease
While more recent research suggests that the timing of HRT initiation may influence cardiovascular outcomes (with potentially more favorable effects when started closer to menopause) 2, 3, 4, the FDA has not approved HRT for heart disease prevention based on the totality of evidence.
Appropriate Use of HRT
HRT should be prescribed for approved indications at the lowest effective dose for the shortest duration necessary 1, 5. The American College of Obstetricians and Gynecologists and other professional organizations recommend:
- Individualizing therapy based on symptom severity, bone health needs, and personal risk factors
- Using 17β-estradiol as the preferred estrogen component
- Adding micronized progesterone for women with an intact uterus 5
Contraindications to HRT
Absolute contraindications include:
- History of hormone-related cancers
- Active liver disease
- History of abnormal vaginal bleeding
- Previous venous thromboembolism or stroke
- Coronary heart disease 5
In conclusion, while HRT is effective for managing menopausal symptoms, preventing osteoporosis, and treating vaginal dryness, it is not FDA-approved for the prevention of heart disease due to evidence showing increased cardiovascular risks.