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Meta-Analysis
. 2025 Mar 1;145(3):253-261.
doi: 10.1097/AOG.0000000000005812. Epub 2025 Jan 2.

Fezolinetant and Elinzanetant Therapy for Menopausal Women Experiencing Vasomotor Symptoms: A Systematic Review and Meta-analysis

Artur Menegaz de Almeida  1 , Paloma Oliveira, Lucca Lopes, Marianna Leite, Victória Morbach, Francinny Alves Kelly, Ítalo Barros, Francisco Cezar Aquino de Moraes, Alexandra Prevedello
Affiliations
Meta-Analysis

Fezolinetant and Elinzanetant Therapy for Menopausal Women Experiencing Vasomotor Symptoms: A Systematic Review and Meta-analysis

Artur Menegaz de Almeida et al. Obstet Gynecol. .

Abstract

Objective: To assess the efficacy and safety of fezolinetant and elinzanetant for vasomotor symptoms in menopausal women.

Data sources: MEDLINE, EMBASE, and Cochrane databases were systematically searched until August 22, 2024. Because the Cochrane Library included all the identified randomized controlled trials (RCTs), it was unnecessary to search ClinicalTrials.gov . The following words made up the search strategy, which was applied to the three databases: fezolinetant, elinzanetant, vasomotor symptoms, and menopause.

Methods of study selection: Only RCTs comparing fezolinetant and elinzanetant with placebo for vasomotor symptoms in menopausal women were included.

Tabulation, integration, and results: We extracted the number of patients, mean age, body mass index (BMI), and number of patients who underwent oophorectomy. Data were examined with the Mantel-Haenszel method and 95% CIs. Heterogeneity was assessed with I2 statistics. R 4.3.2 was used for statistical analysis. Seven RCTs with 4,087 patients were included in the analysis. Fezolinetant and elinzanetant were associated with diminished vasomotor symptom frequency: fezolinetant 30 mg (mean difference 2.16, 95% CI, 1.54-2.79, I2 =0%), fezolinetant 45 mg (mean difference 2.54, 95% CI, 1.86-3.21, I2 =0%), and elinzanetant 120 mg (mean difference 2.99, 95% CI, 1.74-4.23, I2 =0%). Both drugs also showed a decrease in vasomotor symptom severity: fezolinetant 30 mg (mean difference 0.20, 95% CI, 0.09-0.33, I2 =0%), fezolinetant 45 mg (mean difference 0.24, 95% CI, 0.13-0.34, I2 =0%), and elinzanetant 120 mg (mean difference 0.36, 95% CI, 0.26-0.46, I2 =0%). Elinzanetant 120 mg showed a significant improvement in sleep quality (mean difference 4.65, 95% CI, 3.73-5.56, I2 =0%). Elinzanetant 120 mg was associated with the occurrence of drug-related adverse events (11.70% vs 20.75%, risk ratio [RR] 0.57, 95% CI, 0.39-0.82, I2 =19%) and headache (2.54% vs 8.0%, RR 0.32, 95% CI, 0.16-0.64, I2 =0%).

Conclusion: In this meta-analysis, consistent results suggest that fezolinetant and elinzanetant are associated with beneficial outcomes in menopausal women with vasomotor symptoms. Elinzanetant provided a larger effect size in vasomotor symptom frequency and severity reduction and greatly improved sleep quality compared with fezolinetant.

Systematic review registration: PROSPERO, CRD42023469952.

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Conflict of interest statement

Financial Disclosure The authors did not report any potential conflicts of interest.

References

    1. Sourouni M, Zangger M, Honermann L, Foth D, Stute P. Assessment of the climacteric syndrome: a narrative review. Arch Gynecol Obstet 2021;304:855–62. doi: 10.1007/s00404-021-06139-y - DOI
    1. Crandall CJ, Mehta JM, Manson JE. Management of menopausal symptoms: a review. JAMA 2023;329:405–20. doi: 10.1001/jama.2022.24140 - DOI
    1. Mittelman-Smith MA, Williams H, Krajewski-Hall SJ, McMullen NT, Rance NE. Role for kisspeptin/neurokinin B/dynorphin (KNDy) neurons in cutaneous vasodilatation and the estrogen modulation of body temperature. Proc Natl Acad Sci USA 2012;109:19846–51. doi: 10.1073/pnas.1211517109 - DOI
    1. Rance NE, Dacks PA, Mittelman-Smith MA, Romanovsky AA, Krajewski-Hall SJ. Modulation of body temperature and LH secretion by hypothalamic KNDy (kisspeptin, neurokinin B and dynorphin) neurons: a novel hypothesis on the mechanism of hot flushes. Front Neuroendocrinol 2013;34:211–27. doi: 10.1016/j.yfrne.2013.07.003 - DOI
    1. Baber RJ, Panay N, Fenton A; IMS Writing Group. 2016 IMS recommendations on women's midlife health and menopause hormone therapy. Climacteric 2016;19:109–50. doi: 10.3109/13697137.2015.1129166 - DOI