Is hormone replacement therapy (HRT) safe in a postmenopausal woman over 60 years old experiencing vasomotor symptoms?

From the Guidelines

Hormone replacement therapy (HRT) can be considered for women over 60 experiencing vasomotor symptoms of menopause, but it should be used cautiously and only after careful evaluation of individual risks and benefits. For women over 60 with persistent, bothersome vasomotor symptoms:

• Start with the lowest effective dose of estrogen, such as 0.3 mg oral conjugated estrogens or 0.025 mg transdermal estradiol patch.
• If a woman has a uterus, add progestogen for endometrial protection (e.g., 100 mg micronized progesterone daily for 12-14 days per month).
• Use for the shortest duration necessary to control symptoms, typically reassessing annually.
• Consider non-hormonal alternatives first, such as low-dose paroxetine or gabapentin. Before initiating HRT, conduct a thorough health assessment, including breast and cardiovascular risk evaluation. Discuss potential risks, including slightly increased risk of breast cancer, stroke, and venous thromboembolism. The safety profile of HRT changes with age and time since menopause. Women starting HRT more than 10 years after menopause or after age 60 have a higher risk of adverse events. However, for some women, the benefits of symptom relief may outweigh the risks. Transdermal estrogen may have a more favorable risk profile than oral estrogen, particularly regarding venous thromboembolism risk. Individualize treatment decisions based on symptom severity, medical history, and patient preferences. Regular follow-up and reassessment are crucial to ensure ongoing appropriateness of therapy 1.

From the FDA Drug Label

The WHI estrogen plus progestin substudy stratified by age showed in women 50 to 59 years of age a non-significant trend toward reduced risk for overall mortality [HR 0.69 (95 percent CI, 0.44-1. 07)]. The WHIMS estrogen-alone ancillary study of WHI enrolled 2,947 predominantly healthy hysterectomized postmenopausal women 65 to 79 years of age to evaluate the effects of daily CE (0. 625 mg)-alone on the incidence of probable dementia (primary outcome) compared to placebo. The WHIMS estrogen plus progestin ancillary study enrolled 4,532 predominantly healthy postmenopausal women 65 years of age and older to evaluate the effects of daily CE (0.625 mg) plus MPA (2. 5 mg) on the incidence of probable dementia (primary outcome) compared to placebo.

The safety of Hormone Replacement Therapy (HRT) in a postmenopausal woman over 60 years old experiencing vasomotor symptoms is not directly supported by the provided drug labels.

• The Women's Health Initiative (WHI) studies mentioned in the labels were conducted in women 50 to 59 years of age and 65 to 79 years of age, but do not provide direct evidence for women over 60 years old.
• The labels do not provide a clear answer to the question of safety in this specific age group.
• Therefore, a conservative clinical decision would be to exercise caution and consider alternative treatments or consult additional resources before initiating HRT in a postmenopausal woman over 60 years old experiencing vasomotor symptoms 2.

From the Research

Safety of Hormone Replacement Therapy (HRT) in Postmenopausal Women Over 60

• The safety of HRT in postmenopausal women over 60 experiencing vasomotor symptoms is a complex issue, with various studies indicating both benefits and risks 3, 4, 5, 6, 7.
• HRT is considered the gold standard for managing vasomotor and vaginal symptoms of menopause, but it carries significant risks, including stroke, cardiovascular disease, breast cancer, and venous thromboembolism 4.
• Recent studies have indicated that HRT is not related to the risk of all-cause, cardiovascular, or breast cancer mortality, although it might increase the incidence of some chronic diseases 3.
• For symptomatic postmenopausal women under the age of 60 without contraindications, early initiation of HRT is safe and probably has a mortality benefit over the long term 3.
• However, for women over 60, the risks and benefits of HRT need to be carefully weighed, taking into account individual factors such as cardiovascular disease risk, breast cancer risk, and osteoporosis 6.
• Low-dose estrogen-based therapies can be effective in relieving vasomotor symptoms, and can be used by different administration routes and formulations 5.
• Non-hormonal medications, such as selective serotonin reuptake inhibitors and gabapentin, can also be effective in managing vasomotor symptoms 7.
• Shared decision-making between clinicians and patients is essential in determining the best course of treatment for menopausal symptoms, taking into account individual risks and preferences 6, 7.