Abstract
Objective: To evaluate the efficacy and safety of fezolinetant in the treatment of vasomotor symptoms in menopausal women. Materials and methods: A systematic review of the literature was conducted in various electronic databases (Embase, Google Scholar, Pubmed, SciELO, among others) using standardized, open-source search terms, with no language restrictions, between 1980 and 2025. Publications were screened according to inclusion and exclusion criteria. Results: Fifty-eight studies were included, of which five were systematic reviews and seven were meta-analyses. Fezolinetant was shown to be effective and safe in reducing the frequency and severity of vasomotor symptoms (VMS) compared with placebo in postmenopausal women. A 60% to 70% reduction in VMS intensity was observed across different levels. Serious adverse events associated with treatment were rare (2%, 1%, and 0% in women receiving fezolinetant 30 mg, fezolinetant 45 mg, and placebo, respectively). Conclusions: Fezolinetant effectively reduces VMS in postmenopausal women. It also improves quality of life and sleep disturbances, with an adequate safety profile. There is a potential risk of elevated liver enzymes, which require regular monitoring of liver function.
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