October 13, 2017
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HT remains most effective first-line choice for menopausal symptoms

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Nanette Santoro
Nanette Santoro

PHILADELPHIA — Hormone therapy for menopausal women is one of the best examples of precision medicine in clinical practice and remains the most effective first-line treatment for the common symptoms of menopause, according to a speaker here.

The symptoms that can come with the menopause transition vary greatly among women and even by race, Nanette Santoro, MD, professor and chair of reproductive endocrinology and infertility, department of obstetrics and gynecology at the University of Colorado Denver, said during a plenary symposium at the North American Menopause Society Annual Meeting. The decisions of whether to initiate HT — and which formulation — are the embodiment of what precision medicine is all about, she said.

“We practice this every day,” Santoro said, pointing to the NIH definition of precision medicine. “An emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment and lifestyle for each person.”

In explaining the risks and benefits of hormone therapy, Santoro used the analogy of two boxes – one made of tattered cardboard and the other wrapped in nice packaging with a bow. The menopause clinician, she said, has HT data that is represented by the cardboard.

“The data that we have is the box you see on the left,” Santoro said. “There is definitely information out there, but, when looking at our patients across the table, it’s a little beat up, and we have to sort out what is in there. What we must present is this lovely package with a bow on it.”

When assessing the benefits and risks of HT for individual patients, the best evidence comes from the WHI, according to Santoro.

The WHI, Santoro said, was not designed to answer the question of whether to initiate HT.

“Only our patients, in really what is the finest example of precision medicine, can tell us if it is worth it,” Santoro said. “She is the one who balances that seesaw for us. That is the essence of shared decision making.”

FDA-approved versions of HT provide another opportunity to use precision medicine, Santoro said: Options include transdermal hormones, oral hormones, conjugated hormones, vaginal estradiol and bioidentical hormones. Other forms of HT, including SERMS and, now, DHEA, used with or without estrogen, can be factored in as well, she said.

Symptom relief

The symptoms of menopause can be unpleasant, and include night sweats, sleeplessness, anxiety, “brain fog” and sexual symptoms like vaginal dryness, Santoro said. The evidence is “unequivocal” the HT can alleviate the symptoms of hot flashes, night sweats and vaginal dryness, and it is “probably beneficial” for symptoms of poor sleep and adverse mood, she added. However, there is conflicting or inadequate data on whether HT can alleviate symptoms of sexual dysfunction, urinary incontinence, joint pain, brain fog, changes in body composition and skin dryness, she said.

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Discussions surrounding treatment typically begin during the late-menopause transition, when women are more likely to notice symptoms such as vaginal dryness due to declining estrogen levels, Santoro said.

“Depending on what survey you look at, up to 85% of women will report hot flashes and night sweats, and we know they are worse if menopause is surgical and the transition is early or premature,” Santoro said.

Up to 15% of women will have hot flashes before the menopause transition begins, she said, and the length of symptoms can vary greatly, she said.

“I would say 6 or 7 years ago, we thought hot flashes were short lived ... but enter the newer data looking at the duration of symptoms across the transition,” Santoro said. “The number of years goes from 0 to 14 years.”

Hot flash symptoms, severity and length also vary among races, Santoro said, and can vary further within racial groups. Santoro noted differences in hot flash experiences between Hispanic subtypes as one example, calling their different experiences, “another piece of precision medicine.”

“A 10-year duration of hot flashes is not unusual, so we need to rethink our paradigm, because we may have more patients than we used to think with extended use” Santoro said.

Vaginal dryness, which Santoro said is typically underreported and undertreated, also improves with HT for most women, she said. Santoro said one barrier for some menopausal women is what she called “scary FDA labeling” on vaginal estrogen products, which cite risks for CVD, endometrial cancers, breast cancer and probable dementia. These risks, she noted, are often small and in specific groups of women, such as postmenopausal women aged at least 65 years.

“Because hormone therapy has the potential to address multiple symptoms at the same time at low risk when given for short intervals of time, it really remains our treatment of choice,” Santoro said. “If you have an atypical symptom with an unknown likelihood of response, give hormones a try. Many of my patients have the fear factor, but it’s always worth trying. This may be the patient that may get better with hormones, and if she doesn’t get better, she stops them.” – by Regina Schaffer

Reference:

Santoro N. Hormone Therapy: No Sweat for Menopausal Symptoms. Presented at: Annual Meeting of the North American Menopause Society; Oct. 11-14, 2017; Orlando, Fla.

Disclosure: Santoro reports that she serves on a clinical advisory board for Astellas Pharma, Inc. and holds stock options for Menogenix, Inc.