Efficacy and safety of elinzanetant in vasomotor symptoms associated with menopause: A meta-analysis of randomized controlled trials

IF 2.1 4区医学 Q2 OBSTETRICS & GYNECOLOGY

European journal of obstetrics, gynecology, and reproductive biology Pub Date : 2025-01-30 DOI:10.1016/j.ejogrb.2025.01.050

Milene Vitória Sampaio Sobral , Paula Rocha , Livia Kneipp Rodrigues , Abner Mácola Pacheco Barbosa , Naila Camila da Rocha , Clara de Andrade Pontual Peres , Claudio Lucca Lima Furtado , Danieli Pereira da Silva , Marina Ayabe Gomes de Moraes , Veronica Alvarez-Galiana

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引用次数: 0

Abstract

Objective

To evaluate the efficacy and safety of elinzanetant compared to placebo in patients experiencing vasomotor symptoms (VMS) associated with menopause.

Methods

A systematic search of PubMed, Embase, and Cochrane databases identified randomized clinical trials (RCTs) comparing elinzanetant and placebo in patients with menopause-related VMS. Statistical analyses pooled mean difference (MD) and risk ratio (RR) with 95% confidence intervals (CI) using R Studio 4.3.2. Pre-specified outcomes included frequency and intensity of VMS, quality of life, and sleep disturbance.

Results

This meta-analysis included three randomized clinical trials reporting data on 995 patients, with 551 receiving elinzanetant. The mean age ranged from 54.4 to 55.6 years. Elinzanetant significantly reduced VMS frequency (MD −3.09; 95 % CI −4.18 to −2.01; I² = 0 %) and intensity (MD −0.32; 95 % CI −0.43 to −0.21; I² = 39 %). Improvements in quality of life were demonstrated by reduced scores on the Menopause-Specific Quality of Life Questionnaire (MD −0.46; 95 % CI −0.63 to −0.30; I² = 35 %) and better sleep quality measured by the Patient-Reported Outcomes Measurement Information System Sleep Disturbance – Short Form 8b (MD −4.65; 95 % CI −5.56 to −3.73; I² = 0 %). The incidence of adverse events was similar between groups (RR 1.11; 95 % CI 0.99 to 1.25; I² = 35 %).

Conclusion

Elinzanetant reduces the frequency and intensity of VMS and enhances quality of life and sleep quality in patients with menopause-related symptoms. Its safety profile is comparable to placebo.

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来源期刊

European journal of obstetrics, gynecology, and reproductive biology 医学-妇产科学

CiteScore

4.60

自引率

3.80%

发文量

898

审稿时长

8.3 weeks

期刊介绍： The European Journal of Obstetrics & Gynecology and Reproductive Biology is the leading general clinical journal covering the continent. It publishes peer reviewed original research articles, as well as a wide range of news, book reviews, biographical, historical and educational articles and a lively correspondence section. Fields covered include obstetrics, prenatal diagnosis, maternal-fetal medicine, perinatology, general gynecology, gynecologic oncology, uro-gynecology, reproductive medicine, infertility, reproductive endocrinology, sexual medicine and reproductive ethics. The European Journal of Obstetrics & Gynecology and Reproductive Biology provides a forum for scientific and clinical professional communication in obstetrics and gynecology throughout Europe and the world.