
Choosing Among Hormonal and Nonhormonal VMS Therapies in Menopause
Pauline M. Maki, PhD, discusses how the boxed-warning removal for hormone therapy and an expanding class of neurokinin-targeted therapies broaden options, and shares her key takeaway from OPTION-VMS.
This content is sponsored by Astellas, Inc but was independently developed by MJH Life Sciences
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Pauline M. Maki, PhD, explains that clinicians caring for midlife women now have a range of solutions for vasomotor symptoms (VMS). In her view, removal of the boxed warning from estrogen-containing hormone therapy, the most significant warning a medication can carry, has removed much of the stigma and concern many women had about using hormone therapy. Alongside hormone therapy, she notes, nonhormonal options include fezolinetant (Veozah), which targets the source of hot flashes in the brain through the neurokinin pathway to provide rapid and effective relief. Overall, Maki says, this gives clinicians and women reassurance that treatment options are available.
She contrasts this with practice 5 or 10 years ago, when women who could not take hormone therapy because of a clotting disorder or history of breast cancer, or who preferred not to, had limited choices: low-dose paroxetine, which is FDA approved with a small but significant benefit on VMS, or off-label SSRIs, SNRIs, gabapentin, or oxybutynin. Discovery of the brain source of hot flashes has expanded the class of FDA-approved treatments to include neurokinin-targeted therapies. Fezolinetant is an NK3 receptor antagonist, and elinzanetant (Lynkuet) is a dual NK1/NK3 receptor antagonist with an additional mechanism that Maki says may be clinically important for sleep, although research continues. She describes both as FDA approved, highly effective for VMS, and beneficial for sleep, which is particularly important for women who decline hormone therapy because of concerns about breast cancer or cardiovascular risk.
Maki's key takeaway is that the SKYLIGHT trials established efficacy, and OPTION-VMS suggests those findings generalize to real-world patients. In first data cuts presented at scientific meetings and soon to be submitted for publication, women showed significant improvements from baseline to 12 weeks in hot flash bother, subjective sleep quality, depression and mood, and objective sleep measured with actigraphy.
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