TOPLINE:

Elinzanetant vs placebo reduced hot flashes and night sweats by 74% vs 47% at 12 weeks in postmenopausal women. The benefits lasted 52 weeks with no major safety concerns reported.

METHODOLOGY:

• Researchers ran a phase 3 clinical trial at 83 sites across North America and Europe, enrolling 628 postmenopausal women aged 40-65 years seeking treatment for moderate-to-severe hot flashes and night sweats.
• Participants were randomly assigned to take either 120 mg of elinzanetant or a matching placebo once daily for 52 weeks, without a minimum number of hot flashes or night sweats required to enroll.
• The primary outcome was the change in daily moderate-to-severe hot flashes and night sweats from baseline to week 12, using a method that tracks changes in each participant over time.
• Secondary endpoints assessed changes over 52 weeks in sleep problems and in overall well-being related to menopause, using a validated patient-reported sleep questionnaire.

TAKEAWAY:

• Mean change from baseline in daily moderate-to-severe hot flashes at week 12 was -5.4 (95% CI, -6.3 to -4.5) with elinzanetant compared with -3.5 (95% CI, -4.1 to -2.9) with placebo, with an adjusted difference between groups of -1.6 (95% CI, -2.0 to -1.1; P < .001).
• Participants experienced an average of 1.4 moderate-to-severe hot flashes per day by week 50 (95% CI, 1.1-1.7) with elinzanetant compared to 3.5 per day (95% CI, 2.8-4.2) with placebo.
• About 30% vs 15% of people taking elinzanetant vs the placebo had side effects related to the treatment, with the most common side effects being drowsiness, tiredness, and headache.
• Safety checks over 52 weeks showed no liver damage, abnormal thickening of the uterine lining, or significant changes in bone density or bone health markers.

IN PRACTICE:

“As women may experience disruptive menopausal symptoms for multiple years, this study aimed to fulfill the need for longer-term evaluation of hormone-free alternative treatments for VMS [vasomotor symptoms],” the study authors wrote.

SOURCE:

The study was led by Nick Panay, MBBS, of the Queen Charlotte’s and Chelsea Hospital, Imperial College London in London, England. It was published online on September 8 in JAMA Internal Medicine.

LIMITATIONS:

The study may not apply to all ages, ethnic groups, or health conditions, it and excluded women on certain medications or with recent cancer. It wasn’t designed to assess sleep or menopause-related quality of life. Ongoing trials (NIRVANA and OASIS-4) are exploring these effects.

DISCLOSURES:

Various study authors reported receiving support, fees, or grants from companies including Bayer, Abbott, Astellas, Pfizer, Merck, and Novo Nordisk; holding leadership roles in the International Menopause Society; and being current/former Bayer employees. No other disclosures were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.