Summary

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• This summary is based on the review of four systematic review(s)/meta-analysis(es). ^[1-4]
• Fezolinetant at doses of 30 mg and 45 mg daily significantly reduced the frequency and severity of vasomotor symptoms (VMS) in postmenopausal women compared to placebo at both 4 and 12 weeks. A mean daily reduction in VMS frequency at week 12 was observed (mean difference (MD) -2.36; 95% confidence interval (CI) -2.85 to -1.87; P < .00001).
• Fezolinetant 45 mg demonstrated superior efficacy in reducing moderate to severe VMS frequency compared to non-hormonal therapies (paroxetine, desvenlafaxine, gabapentin extended-release (ER)) and placebo. It was comparable in effectiveness to most hormone therapies but less effective than tibolone 2.5 mg and conjugated estrogens 0.625 mg/bazedoxifene 20 mg for achieving a ≥75% reduction in VMS frequency.
• The population studied included postmenopausal women with moderate to severe VMS (≥7 VMS per day or ≥50 VMS per week), showing significant improvements in quality of life scores (menopause-specific quality of life (MENQoL), hot flash-related daily interference scale (HFRDIS), and Greene climacteric scale (GCS)).
• Fezolinetant at 90 mg BID, 30 mg QD, or 45 mg QD did not show a significant difference in the rate of treatment-emergent adverse events (TEAES), headaches, or TEAEs leading to permanent discontinuation compared to placebo. A slight increase in drug-related TEAEs was observed (relative risk (RR) 1.21; 95% CI 0.90-1.63; P = .21), although this was not statistically significant.
• Uterine bleeding incidence was lower with fezolinetant, while trends for endometrial events and hepatotoxicity increased slightly but remained statistically insignificant. There was also a potential, though insignificant, concern for increased risk of endometrial hyperplasia or tumors.
• The study populations predominantly included postmenopausal women experiencing moderate to severe VMS, with one study involving women who had ≥7 VMS per day or ≥50 VMS per week. Clinically relevant improvements in quality of life, as measured by MENQoL, HFRDIS, and GCS scores, were observed in postmenopausal women treated with fezolinetant.