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

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.