Is Hormone Replacement Therapy (HRT) safe in postmenopausal women over 70 years of age?

From the Guidelines

Hormone replacement therapy (HRT) is not recommended for women over 70 due to the increased risk of adverse effects, including breast cancer, stroke, blood clots, and heart disease, as supported by the study published in the Annals of Internal Medicine 1. The risks associated with HRT, as outlined in the study, include 7 additional coronary heart disease (CHD) events, 8 more strokes, 8 more pulmonary emboli, and 8 more invasive breast cancers per 10,000 women taking estrogen and progestin for 1 year 1. While some benefits, such as 6 fewer cases of colorectal cancer and 5 fewer hip fractures, are noted, the overall risk-benefit analysis suggests that HRT is not suitable for most women over 70. Key considerations for women over 70 experiencing severe menopausal symptoms include:

• Very low-dose local estrogen treatments for specific symptoms like vaginal dryness or urinary issues, which have minimal systemic absorption and fewer risks than oral or transdermal HRT.
• Alternative non-hormonal treatments, such as selective serotonin reuptake inhibitors (SSRIs), gabapentin, or lifestyle modifications, which may be safer options for managing symptoms in this age group. Any decision regarding HRT in women over 70 should be highly individualized, taking into account individual health history, family history, and personal risk factors, and using the lowest effective dose for the shortest time possible if HRT is deemed necessary, as recommended by the USPSTF 1.

From the FDA Drug Label

The WHIMS estrogen-alone ancillary study of WHI enrolled 2,947 predominantly healthy hysterectomized postmenopausal women 65 to 79 years of age (45 percent were 65 to 69 years of age; 36 percent were 70 to 74 years of age; 19 percent were 75 years of age and older) 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 (47 percent were 65 to 69 years of age; 35 percent were 70 to 74 years of age; 18 percent were 75 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 women over 70 is not directly supported by the provided drug labels.

• The Women's Health Initiative Memory Study (WHIMS) found an increased risk of probable dementia in women 65 to 79 years of age taking conjugated estrogens (CE) alone or with medroxyprogesterone acetate (MPA) 2, 3.
• The studies did not provide sufficient evidence to determine the safety of HRT in women over 70.
• Therefore, it is recommended to exercise caution when considering HRT in this age group.

From the Research

Safety of HRT in Women Over 70

The safety of Hormone Replacement Therapy (HRT) in women over 70 is a topic of interest, with various studies providing insights into its effects.

• The study 4 suggests that HRT can prevent osteoporosis and cardiovascular disease in symptomatic, early postmenopausal women, but it does not specifically address women over 70.
• Another study 5 focuses on estrogen therapy for osteoporosis, indicating its efficacy in improving bone mineral density and reducing fracture risk, but again, it does not directly address the safety in women over 70.
• A more recent review 6 summarizes current recommendations for HRT use, discussing its benefits for menopausal symptoms and potential long-term effects on bone and cardiovascular health, without specifically focusing on women over 70.
• The evolving role of oral hormonal therapies, including conjugated estrogens/bazedoxifene, is discussed in 7, highlighting its efficacy in managing menopausal symptoms and preventing osteoporosis, but not specifically addressing the safety in women over 70.
• An earlier review 8 from 2003 discusses the benefits and harms of HRT, including prevention of osteoporotic fractures and colorectal cancer, but also notes harms such as coronary heart disease, stroke, and breast cancer, particularly with long-term use, but does not provide specific guidance for women over 70.

Key Considerations

• The majority of the studies suggest that HRT is generally safe when started in symptomatic women before the age of 60 or within 10 years of menopause onset, considering individual characteristics and risk profiles.
• However, there is limited direct evidence regarding the safety of HRT specifically in women over 70, indicating a need for careful consideration of the risk-benefit profile for this age group.
• Individualization of HRT, considering the type, dose, and duration of therapy, as well as patient preferences and emerging risks, is crucial for maximizing benefits while minimizing risks.