Year: 2024
Type: article
Abstract: The vasomotor symptoms (hot flashes, night sweats) and sleep disturbances associated with menopause can significantly impair women's quality of life and long-term health. Nonhormonal drugs that act on neurokinin (NK) receptors have been identified as an effective treatment option, with fezolinetant the first drug in this class to receive Food and Drug Administration approval, in 2023, for the treatment of moderate to severe vasomotor symptoms due to menopause. Two Phase 3 trials evaluated the effects of elinzanetant, a nonhormonal compound targeting both NK-1 and NK-3 receptors, on moderate to severe vasomotor symptoms associated with menopause. The OASIS 1 and 2 studies were 26-week trials enrolling postmenopausal women aged 40 to 65 who experienced at least 50 moderate to severe vasomotor symptoms over 7 days during screening. Among the exclusion criteria were abnormal liver parameters and endometrial hyperplasia or polyps. Participants were randomized to elinzanetant 120 mg/day or placebo for the first 12 weeks. All participants then received elinzanetant 120 mg/day for the remaining 14 weeks of the trial. The primary outcome was mean change in frequency and severity of moderate to severe vasomotor symptoms from baseline to weeks 4 and 12 of treatment. Secondary outcomes included mean change from baseline to week 12 in total score on the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form and the Menopause-Specific Quality of Life questionnaire. Safety assessments included measures of adverse events, laboratory tests, transvaginal ultrasonography, and endometrial biopsy. The two studies comprised 796 participants. In both trials, participants receiving elinzanetant experienced significantly greater reductions in the frequency and severity of vasomotor symptoms at weeks 4 and 12 compared with placebo. Improvement from baseline in sleep disturbances was significantly greater in the elinzanetant group at week 12 in both studies. Quality-of-life improvement also was significantly greater at week 12 in participants receiving elinzanetant. Improvements in the elinzanetant group were sustained in the second phase of the trials. Treatment-emergent adverse events were reported in 51.3% of the elinzanetant group and 48.5% of the placebo group over the first 12 weeks, with headache and fatigue more common in women receiving elinzanetant. “Elinzanetant has the potential to provide a well-tolerated and efficacious nonhormonal treatment option to address the unmet health needs of many menopausal individuals with moderate to severe [vasomotor symptoms],” authors of the studies wrote. [Pinkerton, J., et al. (2024). JAMA. https://doi.org/10.1001/jama.2024.14618]
DOI: 10.1002/pu.31265
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4405736294