Time to take the fear out of the hormone therapy conversation

PHILADELPHIA – It’s time to be clear about the benefits of hormone therapy for many women in midlife, JoAnn Pinkerton, MD, executive director of the North American Menopause Society, said during the keynote address at the group’s annual meeting.

“I want to take fear out of the conversation. Hormone therapy remains the most effective treatment for vasomotor symptoms and the genitourinary syndrome of menopause and has been shown to prevent bone loss and fracture,” said Dr. Pinkerton, who also chaired the advisory panel that penned the 2017 NAMS position statement on hormone therapy.

^{Courtesy University of Virginia Health System}

Dr. JoAnn Pinkerton helped write the NAMS position statement on hormone therapy.

Hormone therapy is currently approved by the Food and Drug Administration as first-line therapy to relieve vasomotor symptoms (VMS). Low-dose vaginal estrogen therapy is also a first-line treatment for the genitourinary syndrome of menopause, since it can directly address vulvovaginal atrophy.

An additional approved indication for systemic hormone therapy (HT) is the prevention of bone loss and fracture reduction in postmenopausal women who have increased risk of osteoporosis or fractures. It’s also FDA approved for women who had hypogonadism, primary ovarian insufficiency, or premature surgical menopause, who may use HT until the average age of menopause – about 52 years.

Unopposed systemic estrogen should not be used as HT in women with an intact uterus because of the elevated risk of endometrial cancer, and all indications assume there are no contraindications to HT use.

The position statement was developed by an expert panel, and has been endorsed by a number of international menopause societies, other American women’s health societies, and the American Association of Clinical Endocrinologists.

Cardiovascular risks

Early analysis of cardiovascular health data from the large, prospective Women’s Health Initiative trial raised significant concerns about increased risk. But further study of data from the Women’s Health Initiative, as well as meta-analyses of randomized controlled trials, have yielded a more nuanced view of the relationship between HT and cardiovascular disease, she said.

“Age matters,” Dr. Pinkerton said. “Data show that there is reduced heart disease in women who start [hormone replacement] early.” There is increasing data, she said, to support the “timing hypothesis.”

“Women who start HT before the age of 60 years, or within 10 years of menopause, may have a reduced risk of coronary heart disease,” Dr. Pinkerton said. “There is concern of increased risk of [coronary heart disease] in women who initiate hormone therapy more than 10 or 20 years from menopause.”

Use of HT is associated with a significantly increased risk of venous thromboembolism, a risk that increases with time, as does the risk of stroke and pulmonary embolism. Using lower doses or transdermal HT may reduce this risk, but “the lack of comparative randomized controlled trial data limit recommendations,” she said.

Transdermal therapy can also be considered for women with metabolic syndrome, hypertriglyceridemia, and fatty liver, since this route avoids first-pass hepatic metabolism.

Breast cancer

“The effect of hormone therapy on breast cancer risk is complex and conflicting,” said Dr Pinkerton, noting that breast cancer risk from HT may depend on many factors, including whether progestins are added to estrogen, the dose and duration of HT use, and how HT is administered.

Regarding the use of vaginal estrogen for women who have had breast cancer, Dr. Pinkerton said, “It’s a data-free zone.” Systemic absorption of vaginally-dosed estrogen is minimal, but the decision to use vaginal estrogen for a breast cancer survivor who is experiencing genitourinary syndrome of menopause symptoms should always be made in consultation with the woman’s oncologist and in shared decision-making with the patient herself, Dr. Pinkerton added.

Bioidentical HT

“Unique concerns about safety surround the use of compounded bioidentical hormone therapy,” Dr. Pinkerton said.

The lack of regulation and monitoring, together with lax labeling requirements, are areas of concern. Accurate dosing may not be occurring, and data are lacking to support safety and efficacy of compounded bioidentical products, she said. Neither is there evidence to support routine testing of serum or salivary hormone levels, she added.

Symptom relief

For isolated symptoms of genitourinary syndrome of menopause, low-dose vaginal preparations are safe and effective, Dr. Pinkerton said. For women who are symptomatic, use of either low-dose vaginal estrogen or systemic HT increases sexual function scores; however, she said, “hormone therapy is not recommended as the sole treatment of other sexual function problems,” such as diminished libido, though it can be a useful adjunct.