Efficacy and safety of fezolinetant for vasomotor symptoms in postmenopausal women: a comprehensive systematic review and meta-analysis of randomized controlled trials.
Majd M AlBarakat, Jehad Feras AlSamhori, Ahmed Abdelaziz, Amr Elrosasy, Mohamad A Elzeftawy, Rana Ahmed Youssef, Rana B Altawalbeh, Mohamed Abuelazm, Basel Abdelazeem
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引用次数: 0
Abstract
Introduction: Approximately 360 million women globally experience hot flashes, with varying rates influenced by cultural and racial factors. Vasomotor symptoms (VMS) impact 80% of US women during menopause, with emerging risk factors including high body mass index and African American ancestry. Fezolinetant, an oral neurokinin-3 receptor antagonist, showed promising efficacy in managing VMS. We aimed to comprehensively assess the impact of fezolinetant on VMS in postmenopausal women.
Methods: We searched PubMed, Cochrane, Web of Science, SCOPUS, and EMBASE until July 2023 for randomized controlled trials comparing fezolinetant to placebo in women with moderate to severe VMS. Primary outcomes encompassed VMS frequency and severity, and secondary outcomes included treatment effects, quality of life, and safety. Data were collected and analyzed using STATA 17 MP.
Results: We included six studies with 3657 patients. Fezolinetant significantly reduced VMS frequency at both 4 weeks (Cohen's d = -0.56; 95% confidence interval [CI], -0.79, -0.34; P < 0.001) and 12 weeks (Cohen's d = -0.34; 95% CI, -0.45, -0.14; P < 0.001). In terms of secondary outcomes, fezolinetant significantly improved health-related functioning and global clinical summary scores, particularly with the 90 mg twice per day dosage. Crucially, there were no statistically significant differences between fezolinetant and placebo concerning the occurrence of any treatment-emergent (odds ratio [OR] = 1.01, P = 0.81) or serious (OR = 1.57, P = 0.90) adverse events.
Conclusion: Fezolinetant effectively reduces VMS in postmenopausal women at both 4 and 12 weeks, aligning with previous research. It also improves quality of life, with a promising safety profile. Given fezolinetant's potential for liver enzyme elevations, it is essential to monitor liver function at baseline and regularly thereafter (monthly for the first 3 months and at 6 and 9 months) to ensure patient safety. Further studies with larger sample sizes are needed to confirm these findings.
导读:全球约有3.6亿女性经历过潮热,受文化和种族因素的影响,潮热率各不相同。血管舒缩症状(VMS)影响80%的绝经期美国女性,新出现的危险因素包括高体重指数和非裔美国人血统。Fezolinetant是一种口服神经激肽-3受体拮抗剂,在治疗VMS方面显示出良好的疗效。我们的目的是全面评估非唑啉坦对绝经后妇女VMS的影响。方法:我们检索PubMed, Cochrane, Web of Science, SCOPUS和EMBASE,直到2023年7月,比较fezolinetant和安慰剂在中重度VMS女性患者中的随机对照试验。主要结局包括VMS发生频率和严重程度,次要结局包括治疗效果、生活质量和安全性。数据收集和分析使用STATA 17mp。结果:我们纳入了6项研究,共3657例患者。Fezolinetant在4周时显著降低了VMS频率(Cohen’s d = -0.56;95%置信区间[CI], -0.79, -0.34;P P = 0.81)或严重不良事件(or = 1.57, P = 0.90)。结论:Fezolinetant在绝经后4周和12周有效降低VMS,与先前的研究一致。它还提高了生活质量,并具有良好的安全性。考虑到fezolinetant可能导致肝酶升高,必须在基线和之后定期监测肝功能(前3个月每月一次,第6和9个月),以确保患者安全。需要更大样本量的进一步研究来证实这些发现。