Efficacy and safety of fezolinetant for moderate to severe vasomotor symptoms associated with menopause among women in East Asia: a phase 3 randomized study (MOONLIGHT I)

Autor: Xiangyan Ruan, Wenpei Bai, Mulan Ren, Tak Kim, Ji Young Lee, Fei-Chi Chuang, Peng-Hui Wang, Weizhong He, Xiao Ma, Kentaro Miyazaki, Nan Song, Xuegong Wang, Qi Yu
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Journal of International Medical Research, Vol 52 (2024)
Druh dokumentu: article
ISSN: 1473-2300
03000605
DOI: 10.1177/03000605241247684
Popis: Objective To evaluate the efficacy and safety of fezolinetant for moderate to severe vasomotor symptoms (VMS) associated with menopause in East Asian women. Methods In this phase 3, randomized, double-blind study, postmenopausal women with moderate to severe VMS (minimum average frequency in the 10 days before randomization, ≥7/day or 50/week) received fezolinetant 30 mg/day or placebo (weeks 1–12), followed by an open-label extension phase with fezolinetant 30 mg/day (weeks 13–24). The co-primary endpoints were the mean changes in the daily frequency and severity of VMS at weeks 4 and 12. Results Among 301 participants, the difference in the least squares mean change (95% confidence interval) from baseline in the daily frequency of moderate to severe VMS versus placebo was −0.65 (−1.41 to 0.12) at week 4 and −0.55 (−1.35 to 0.26) at week 12. The differences in the least squares mean change from baseline in the VMS severity score versus placebo were −0.06 (−0.14 to 0.03) and −0.13 (−0.27 to 0.01) at weeks 4 and 12, respectively. Serious adverse events occurred in 0.7% of participants receiving fezolinetant in weeks 1 to 12, compared with 1.3% of those receiving placebo. Conclusions Fezolinetant was generally safe but did not reduce the frequency or severity of VMS versus placebo in postmenopausal women in this study. ClinicalTrials.Gov Identifier: NCT04234204
Databáze: Directory of Open Access Journals
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