PDF(Pubmed)
Abstract：
OBJECTIVE: We aimed to assess long-term safety and tolerability of fezolinetant, a nonhormonal neurokinin 3 receptor antagonist, among Chinese women with vasomotor symptoms associated with menopause participating in the MOONLIGHT 3 trial.
METHODS: In this phase 3 open-label study, women in menopause aged 40-65 years received fezolinetant 30 mg once daily for 52 weeks. The primary endpoint was frequency and severity of treatment-emergent adverse events (TEAEs), assessed at every visit through week 52 and one follow-up visit at week 55.
RESULTS: Overall, 150 women were enrolled (mean age, 54 years) and 105 completed treatment. The frequency of TEAEs was 88.7%. Most TEAEs were mild (63.3%) or moderate (22.7%). The most common TEAE was upper respiratory tract infection (16.0%), followed by dizziness, headache, and protein urine present (10.7% each). There was no clinically relevant change (mean ± standard deviation) in endometrial thickness (baseline, 2.95 ± 1.11 mm; week 52, 2.94 ± 1.18 mm). Alanine aminotransferase and/or aspartate aminotransferase levels >3 times the upper limit of normal were reported in 1.4% of women; no Hy\'s Law cases occurred.
CONCLUSIONS: Fezolinetant 30 mg once daily was generally safe and well tolerated over a 52-week period among women in China with vasomotor symptoms associated with menopause.ClinicalTrials.gov Identifier: NCT04451226.
METHODS: In this phase 3 open-label study, women in menopause aged 40-65 years received fezolinetant 30 mg once daily for 52 weeks. The primary endpoint was frequency and severity of treatment-emergent adverse events (TEAEs), assessed at every visit through week 52 and one follow-up visit at week 55.
RESULTS: Overall, 150 women were enrolled (mean age, 54 years) and 105 completed treatment. The frequency of TEAEs was 88.7%. Most TEAEs were mild (63.3%) or moderate (22.7%). The most common TEAE was upper respiratory tract infection (16.0%), followed by dizziness, headache, and protein urine present (10.7% each). There was no clinically relevant change (mean ± standard deviation) in endometrial thickness (baseline, 2.95 ± 1.11 mm; week 52, 2.94 ± 1.18 mm). Alanine aminotransferase and/or aspartate aminotransferase levels >3 times the upper limit of normal were reported in 1.4% of women; no Hy\'s Law cases occurred.
CONCLUSIONS: Fezolinetant 30 mg once daily was generally safe and well tolerated over a 52-week period among women in China with vasomotor symptoms associated with menopause.ClinicalTrials.gov Identifier: NCT04451226.
摘要：
目的：我们旨在评估非唑尼坦的长期安全性和耐受性，非激素神经激肽3受体拮抗剂，在参与MOONLIGHT3试验的绝经相关血管舒缩症状的中国女性中。
方法：在此阶段3开放标签研究中，40-65岁的绝经期女性接受非唑尼坦30mg,每日1次,共52周.主要终点是治疗引起的不良事件（TEAE）的频率和严重程度，在第52周的每次访问中进行评估，并在第55周进行一次随访。
结果：总体而言，150名妇女登记(平均年龄，54年）和105完成治疗。TEAE的频率为88.7%。大多数TEAE为轻度（63.3%）或中度（22.7%）。最常见的TEAE是上呼吸道感染（16.0%），接着是头晕,头痛,和尿蛋白（各10.7％）。子宫内膜厚度（基线，2.95±1.11毫米；第52周，2.94±1.18毫米）。1.4%的女性报告丙氨酸氨基转移酶和/或天冬氨酸氨基转移酶水平>正常上限的3倍；没有发生Hy/s法病例。
结论：Fezolinetant30mg每日1次在52周期间在中国有与更年期相关的血管舒缩症状的女性中通常是安全且耐受性良好的。ClinicalTrials.gov标识符：NCT04451226。
方法：在此阶段3开放标签研究中，40-65岁的绝经期女性接受非唑尼坦30mg,每日1次,共52周.主要终点是治疗引起的不良事件（TEAE）的频率和严重程度，在第52周的每次访问中进行评估，并在第55周进行一次随访。
结果：总体而言，150名妇女登记(平均年龄，54年）和105完成治疗。TEAE的频率为88.7%。大多数TEAE为轻度（63.3%）或中度（22.7%）。最常见的TEAE是上呼吸道感染（16.0%），接着是头晕,头痛,和尿蛋白（各10.7％）。子宫内膜厚度（基线，2.95±1.11毫米；第52周，2.94±1.18毫米）。1.4%的女性报告丙氨酸氨基转移酶和/或天冬氨酸氨基转移酶水平>正常上限的3倍；没有发生Hy/s法病例。
结论：Fezolinetant30mg每日1次在52周期间在中国有与更年期相关的血管舒缩症状的女性中通常是安全且耐受性良好的。ClinicalTrials.gov标识符：NCT04451226。
