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Effectiveness and safety of fezolinetant in alleviating vasomotor symptoms linked to Menopause.: A systematic review and Meta-Analysis.

Authors :
Elnaga, Ahmed A. Abo
Alsaied, Mohamed A.
Elettreby, Abdelrahman M.
Ramadan, Alaa
Source :
European Journal of Obstetrics & Gynecology & Reproductive Biology. Jun2024, Vol. 297, p142-152. 11p.
Publication Year :
2024

Abstract

• Fezolinetant significantly reduces frequency/severity of menopausal symptoms. VMS episodes decrease, severity scores improve at 4/12 weeks. • Fezolinetant enhances menopause-specific quality of life scores at 4/12 weeks, suggesting meaningful well-being improvement. • Fezolinetant shows efficacy but poses increased risk of adverse events: drug-related, serious adverse events, fatigue, arthralgia, elevated liver enzymes. • Fezolinetant offers non-hormonal alternative for managing VMS, despite safety considerations, improving quality of life for postmenopausal women. Vasomotor symptoms (VMS) are the most common symptoms during menopause including hot flushes and night sweats. They are highly disruptive to the quality of life. Fezolinetant is an FDA-approved non-hormonal selective neurokinin3 receptor antagonist for the treatment of VMS. In this study, we aim to assess the efficacy and safety of fezolinetant for VMS associated with menopause. Databases were searched until September 2023 for relevant studies comparing fezolinetant against placebo. Data was extracted into an online form and analyzed using RevMan (Version 5.4.1). The GRADE approach was conducted to evaluate the quality of evidence regarding efficacy outcomes. We included randomized controlled trials (RCTs) comparing fezolinetant to placebo in postmenopausal women experiencing VMS. Exclusion criteria comprised studies involving participants with contraindications to fezolinetant or those evaluating its efficacy for indications other than VMS associated with menopause. Six studies were included in this study involving 3301 patients. Compared to placebo, fezolinetant reduced the frequency of VMS episodes from baseline (SMD = -0.64, 95 % CI [-0.77, −0.5]) and (SMD = -0.63, 95 % CI [-0.72, −0.53] at weeks 4 and 12 respectively. Additionally, fezolinetant reduced VMS severity score (SMD = -0.59, 95 %CI [-0.77, −0.42]) and (SMD = -0.4, 95 % CI [-0.54, −0.27]) at weeks 4 at 12 respectively. These reductions were positively reflected on Menopause specific quality of life score (SMD = -0.46, 95 %CI [-57, −0.34]), (SMD = -0.37, 95 %CI [-0.48, −0.25]) at weeks 4 and 12 respectively. Regarding safety analysis, fezolinetant showed increased risk for drug-related TEAEs (RR = 1.47, 95 %CI [1.06,2.04]), serious TEAEs (RR = 1.67, 95 %CI [1.09,2.55]), fatigue (RR = 4.05, 95 %CI [1.27,12.88]), arthralgia (RR = 2.83, 95 %CI [1.02,7.8]) and ALT or AST > 3 times (RR = 2, 95 %CI [1.12,3.57]), with no other statistically significant difference regarding other safety terms. Fezolinetant has demonstrated efficacy in reducing the frequency and severity of VMS in postmenopausal women, leading to an improvement in their quality of life. These findings suggest that Fezolinetant may serve as a viable alternative to hormonal therapy for managing VMS. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
03012115
Volume :
297
Database :
Academic Search Index
Journal :
European Journal of Obstetrics & Gynecology & Reproductive Biology
Publication Type :
Academic Journal
Accession number :
177288909
Full Text :
https://doi.org/10.1016/j.ejogrb.2024.04.017