Academic Unit of Obstetrics and Gynaecology, IRCCS Ospedale Policlinico San Martino , Genova, Italy.
Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (Dinogmi), University of Genova , Italy.
Expert Opin Pharmacother. 2020 Aug;21(12):1419-1430. doi: 10.1080/14656566.2020.1755254. Epub 2020 May 13.
Uterine myomas represents a widespread gynecological disease of women in reproductive age. Although surgery remains the first choice for treating most patients, in the last years, new medical approaches have been considered in order to ameliorate heavy menstrual bleeding (HMB) related to their presence. Elagolix is a second-generation gonadotropin-releasing hormone (GnRH) antagonist under investigation for the long-term treatment of uterine myomas.
The aim of this drug evaluation is to give a complete overview of pharmacokinetic and pharmacodynamic data on elagolix for treating HMB related to uterine myomas and to report the results of the current clinical trials in this setting.
In two previous phase II studies, this drug succeeded in ameliorating blood loss and quality of life of patients affected by uterine myomas with a good safety profile. Three phase III trials (ELARIS UF-I, UF-II, and EXTEND) investigated the efficacy, tolerability, and safety of elagolix at 300 mg twice daily with add-back therapy. The primary endpoint, consisting in the reduction in HMB compared to placebo, was met in the majority of patients under treatment. Currently, elagolix is under investigation in two other ongoing multicenter phase III clinical studies.
子宫肌瘤是生育期妇女中一种常见的妇科疾病。尽管手术仍然是治疗大多数患者的首选方法，但近年来，为了改善与肌瘤相关的月经过多（HMB），已经考虑了新的医疗方法。Elagolix 是第二代促性腺激素释放激素（GnRH）拮抗剂，正在研究用于长期治疗子宫肌瘤。
本药物评价旨在全面概述 Elagolix 治疗与子宫肌瘤相关的 HMB 的药代动力学和药效学数据，并报告该药物在该治疗环境中的当前临床试验结果。
在两项先前的 II 期研究中，该药物成功地改善了患有子宫肌瘤的患者的失血和生活质量，且安全性良好。三项 III 期试验（ELARIS UF-I、UF-II 和 EXTEND）研究了 Elagolix 在每日两次 300mg 剂量下联合辅助治疗的疗效、耐受性和安全性。大多数接受治疗的患者达到了与安慰剂相比减少 HMB 的主要终点。目前，Elagolix 正在另外两项正在进行的多中心 III 期临床研究中进行研究。
