Fezolinetant for the treatment of vasomotor symptoms associated with menopause: a meta-analysis

This systematic review and meta-analysis investigated the efficacy and safety of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause. PubMed, Cochrane Library, Embase and Web of Science were searched for randomized controlled trials (RCTs) published from inception to June 2023, comparing fezolinetant to placebo in postmenopausal women suffering from moderate-to-severe VMS. The mean difference and risk ratio were calculated for continuous and binary outcomes, respectively. R software was used for the statistical analysis, and RoB-2 (Cochrane) to assess the risk of bias. We performed subgroup analysis based on different dosing regimens. Five RCTs comprising 3302 patients were included. Compared with placebo, at 12-week follow-up, fezolinetant significantly reduced the daily frequency of moderate-to-severe VMS (weighted mean difference [WMD] − 2.36; 95% confidence interval [CI] − 2.92, −1.81) and daily severity of moderate-to-severe VMS (WMD −0.22; 95% CI −0.31, −0.13). Also, fezolinetant significantly improved the quality of life (WMD −0.42; 95% CI −0.58, −0.26) and sleep disturbance (WMD −1.10; 95% CI −1.96, −0.24). There were no significant differences between groups in adverse events. These findings support the efficacy and safety of fezolinetant for the treatment of VMS related to menopause.

本项系统评价与荟萃分析旨在探讨费卓林泰（fezolinetant）治疗绝经相关中重度血管舒缩症状（vasomotor symptoms, VMS）的有效性与安全性。本研究检索了PubMed、Cochrane图书馆、Embase及Web of Science自建库至2023年6月发表的随机对照试验（randomized controlled trials, RCTs），纳入对比费卓林泰与安慰剂治疗绝经后中重度VMS女性的相关研究。研究分别针对连续性结局与二分类结局计算均数差与风险比，采用R软件开展统计学分析，并使用Cochrane RoB-2工具评估偏倚风险。随后依据不同给药方案进行亚组分析。最终纳入5项随机对照试验，共包含3302例受试者。与安慰剂组相比，在12周随访节点，费卓林泰可显著降低中重度VMS每日发作频率（加权均数差[weighted mean difference, WMD] = -2.36；95%置信区间[confidence interval, CI]：-2.92~-1.81）与中重度VMS每日严重程度（WMD = -0.22；95%CI：-0.31~-0.13）。此外，费卓林泰还可显著改善受试者生活质量（WMD = -0.42；95%CI：-0.58~-0.26）与睡眠障碍情况（WMD = -1.10；95%CI：-1.96~-0.24）。两组不良事件发生率无显著统计学差异。本研究结果证实，费卓林泰用于治疗绝经相关VMS具有可靠的有效性与安全性。