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New guidelines, new thinking, new drugs for menopause
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New guidelines, new thinking, new drugs for menopause

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Women's Health

Sonya Collins

The statement takes into account recent papers that recast the findings of the seminal Women’s Health Initiative (WHI) hormone therapy trials, whose original findings (and framing of them) led to the initial controversy around hormone replacement therapy. Meanwhile, drug developers are gaining ground on nonhormonal therapies for the vasomotor symptoms of menopause.

“Because of fear associated with the results of the Women’s Health Initiative, a lot of patients go without treatment,” said Nicole Cieri-Hutcherson, PharmD, BCPS, NCMP, a clinical assistant professor at the University at Buffalo School of Pharmacy and Pharmaceutical Sciences, who has a special focus on women’s health. “But hormone therapy is the most effective thing we have right now, so completing a risk assessment and counseling patients that most women can use hormone therapy safely with proper oversight can have a significant impact on their quality of life.”

She added that more nonhormonal therapies may soon be an option, too.

Image of a woman in front of a fanTreatment for menopause symptoms continues to be a topic of great controversy among health care providers and menopausal patients themselves. Last year, in an attempt to quell the debate, the North American Menopause Society (NAMS) released an updated position statement on hormone therapy.

NAMS 2022 hormone therapy position statement

In its first updated position statement on hormone therapy since 2017, NAMS offers guidance on hormone prescribing based on literature published since the last statement.

The consensus of the advisory panel of clinicians and researchers states that hormone therapy is the most effective treatment for vasomotor and genitourinary symptoms of menopause and that it may also prevent bone loss and fracture. The benefit-risk ratio is favorable for patients under 60 or who are within 10 years of menopause onset and have no contraindications. Individual risk varies by type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen is used.

The statement emphasizes that for women over 60, or who start hormone therapy more than 10 years after menopause onset, the benefit-risk ratio is not as favorable due to greater absolute risk of heart disease, stroke, blood clot, and dementia.

Recent criticism of the WHI framing

NAMS’ statement comes on the heels of recent papers that critique the framing of the WHI study findings. WHI was a series of NIH-sponsored clinical trials and observational studies started in 1991 that examined major causes of illness and death in postmenopausal patients. The framing of the hormone replacement therapy trial findings seemed to overshadow the benefits of hormone replacement therapy and overemphasize the risks. Among recent papers that critique the trial’s conclusion are the 2021 review of the WHI and other recent hormone therapy trials by Flores and colleagues and published in Endocrine Reviews and a 2022 analysis of the WHI findings by Manson and colleagues published in Menopause.

A key criticism of the WHI trials is that the average age of study participants was 63 years old, and the largest age group was women aged 60 to 69.

“That’s more than ten years out from menopause onset, so there are already higher inherent risks for heart disease, stroke, and breast cancer associated with aging, so the critique is that maybe the Women’s Health Initiative overestimates those risks,” Cieri-Hutcherson said.

New drug class

Though NAMS reaffirms the safety of hormone therapy for some patients, it is not right for everyone, nor is it everyone’s preference. This highlights a need for nonhormonal treatments for the vasomotor symptoms of menopause. A new drug class, neurokinin-3 receptor antagonists, has garnered a great deal of attention and excitement as a way to meet this need.

These drugs block neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron, which in turn moderates neuron activity in the thermoregulatory center of the brain to reduce the frequency and severity of moderate to severe hot flashes.

“Now that we know a little more about how hot flashes work,” Cieri-Hutcherson said, “we are seeing therapies that fall outside of replacing estrogen.”

Astellas Pharma announced last August that FDA has accepted a new drug application for its neurokin-3 receptor antagonist fezolinetant. Other drugs in this class may soon follow. ■

The complete position paper ( offers guidance on formulation, dosing, and routes of administration. ■




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