番茄社区

HOUSTON -- Most postmenopausal women with moderate-to-severe vasomotor symptoms (VMS) also experience clinically significant levels of sleep disturbance, a researcher reported here.

Baseline data from OASIS I and OASIS II, trials evaluating elinzanetant for menopause-associated VMS, showed that about two-thirds or more of these women reported trouble sleeping (62-68%) or staying asleep (71-78%), and sleep that was restless (66-71%) or not refreshing (69-73%), according to Hadine Joffe, MD, MSc, of Harvard Medical School in Boston.

Nearly three-fourths of the women also reported being mostly dissatisfied with their sleep quality (74%), most said they didn't get enough sleep (57-62%), and most described their sleep quality as poor or worse (60-64%). Many said they had trouble falling asleep as well (34-46%), indicated findings presented at the annual SLEEP meeting hosted jointly by the American Academy of Sleep Medicine and the Sleep Research Society.

The trials measured sleep disturbance using the Patient-Reported Outcomes Measurement Information System Sleep Disturbance-Short Form 8b (PROMIS SD-SF-8b) questionnaire. At baseline, the women in the placebo and elinzanetant groups had mean scores that ranged from 60.2 (SD 7.2) to 61.7 (SD 6.2), indicating moderate sleep disturbance.

The proportion of women expressing concern over their sleep was "striking," Joffe told 番茄社区, adding that often people assume worsening sleep difficulty comes with age and they simply try to adapt to it.

"We want people to recognize that actually you should get treated. You deserve to get treated," said Joffe.

"Our society tolerates, and maybe women are socialized, to expect to tolerate a lot of symptom burden and discomfort," she added. "I think we need to reverse that narrative and say this is important for your health."

The main goal of the phase III OASIS trials was to test elinzanetant for moderate-to-severe VMS associated with menopause. As was previously reported, the dual neurokinin-1,3 receptor antagonist met its primary endpoint in both trials, significantly reducing both the frequency and severity of VMS compared with placebo.

Furthermore, the study showed benefit in secondary endpoints as well, including reducing the severity of sleep disturbance. From baseline to week 12, the elinzanetant-treated groups showed greater least squares (LS) mean reductions on PROMIS SD-SF-8b T-scores compared with the placebo group (P<0.0001 for both):

• LS mean change -5.58 (95% CI -7.18 to -3.98)
• LS mean change -4.32 (95% CI -5.77 to -2.86)

and together included nearly 800 postmenopausal women with moderate-to-severe VMS (at least 50 per week) who were enrolled across eight countries. At baseline, women experienced an average of 13.38 to 16.68 moderate-to-severe VMS each day.

The trials had no threshold for severity of sleep disturbances for study entry, and the current analysis included data on 744 of the participants.

PROMIS SD-SF-8b responses were recorded at baseline and nine more times through week 30 of the trial, though Joffe only presented the baseline data.

The questionnaire consists of eight items -- I had difficulty falling asleep; I had difficulty staying asleep; My sleep was restless; My sleep was refreshing; I got enough sleep; My sleep quality was...; I was satisfied with my sleep; I had trouble sleeping -- with each item scored on a 5-point scale and summed to a total T-score, where greater scores indicate worse sleep disturbance.

T-scores <55 indicate normal sleep, while scores of 55 to 60 indicate mild sleep disturbance, 60 to 70 moderate disturbance, and >70 severe sleep disturbance.

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