Efficacy and Safety of Fezolinetant for the Treatment of Menopause-Associated Vasomotor Symptoms

医学 安慰剂 荟萃分析 科克伦图书馆 血管舒缩 随机对照试验 不利影响 更年期 临床试验 梅德林 物理疗法 内科学 严格标准化平均差 替代医学 病理 政治学 法学
作者
Krishna Nikhila Bonga,Archana Mishra,Rituparna Maiti,Biswa Mohan Padhy,Bikash Ranjan Meher,Anand Srinivasan
出处
期刊:Obstetrics & Gynecology [Ovid Technologies (Wolters Kluwer)]
卷期号:143 (3): 393-402 被引量:2
标识
DOI:10.1097/aog.0000000000005508
摘要

OBJECTIVE: To evaluate the efficacy and adverse events of fezolinetant for treating vasomotor symptoms (VMS) of menopause. DATA SOURCES: PubMed/MEDLINE, ClinicalTrials.gov, EMBASE, Cochrane Database, Scopus, and WHO International Clinical Trials Registry Platform were searched through June 2023 for publications and randomized controlled trials on fezolinetant compared with placebo in menopausal women who experienced moderate-to-severe VMS. METHODS OF STUDY SELECTION: Our literature search identified 330 articles, of which five studies with six reports were included in our meta-analysis per our eligibility criteria. TABULATION, INTEGRATION, AND RESULTS: The risk of bias was evaluated using Cochrane's RoB 2 (Risk of Bias version 2) tool, quality of evidence was graded using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach, and outcome measures data for effect size were pooled in random-effects model and rated. A total of 2,168 participants from five randomized clinical trials (six reports) were included. Fezolinetant significantly lowered VMS frequency, with pooled mean difference of 2.62 (95% CI, 1.84–3.41). The pooled mean difference for fezolinetant compared with placebo for the MENQOL (Menopause-Specific Quality of Life) measure was −0.60 (95% CI, −0.92 to −0.28), and the mean percentage improvement in VMS frequency was 22.51% (95% CI, 15.35–29.67). Fezolinetant was associated with improvement in sleep quality when compared with placebo. CONCLUSION: Fezolinetant is effective in lowering moderate-to-severe VMS frequency and sleep disturbances in postmenopausal women. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42023427616.

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