Efficacy and safety of Fezolinetant in moderate to severe vasomotor symptoms associated with menopause: A systematic review and meta-analysis

Abstract Fezolinetant has emerged as a potential treatment by targeting neurokinin B (NKB) signalling disruption and Kisspeptin/neurokinin B/dynorphin (KNDy) neuron activation in the hypothalamus. We aim to evaluate Fezolinetant's efficacy and safety in treating menopause-related VMS. We searched on PubMed, Web of Science (WOS), Scopus, and Cochrane till June 19th, 2023. All relevant randomized clinical trials (RCTs) were included. Our review included all studies that evaluate the efficacy and safety of Fezolinetant. Data were extracted and pooled using Review Manager Software (RevMan version 5.3). The meta-analysis of six studies showed Fezolinetant's significant improvement in vasomotor symptoms (VMSs) compared to placebo in most of the outcomes. Fezolinetant reduces VMS frequency, with mean differences (MDs) of -2.66 (4 weeks) and − 2.46 (12 weeks). VMS severity becomes better, particularly with Fezolinetant 30 mg (MD -0.16, -0.20) and Fezolinetant 45 mg (MD -0.23, -0.29). Additionally, Fezolinetant enhances outcomes in GCS vasomotor symptoms score (MD -2.53, -3.65) and HFRDIS score (MD -1.85, -1.71). PROMIS SD SF 8b reveals favorable results with Fezolinetant 30 mg (MD -1.15, -0.61) and Fezolinetant 45 mg (MD -2.25, -1.55). Regarding the MENQoL total score, Fezolinetant 30 mg (MD -0.45, -0.33) and Fezolinetant 45 mg (MD -0.57, -0.48) show improvement. The favorable tolerability and safety of Fezolinetant make it a promising therapy option for post-menopausal women with VMSs.