a Société de Recherche pour l'Infertilité, Professor Emeritus , Université Catholique de Louvain , Brussels , Belgium.
b Medical Affairs and Safety Departments , PregLem S.A./Gedeon Richter , Geneva , Switzerland.
Expert Opin Drug Saf. 2018 Dec;17(12):1225-1232. doi: 10.1080/14740338.2018.1550070. Epub 2018 Nov 29.
Uterine fibroids are benign tumors within the uterine wall affecting women. Ulipristal acetate 5 mg was first authorized in the European Union on 23 February 2012, with a post-marketing exposure estimated to be more than 765,000 patients so far. During the post-marketing experience, sporadic cases of liver injury and hepatic failure were reported. A detailed review of the clinical trials carried out in the development of ulipristal acetate 5 mg was undertaken to further assess the liver safety data reported during the clinical trials.
A detailed review of clinical data from Phase I to Phase III of patients exposed to ulipristal acetate at any investigated dose levels and for any treatment duration was conducted and the liver function test values are presented. In addition, a literature review on drug-induced liver injury is provided.
The experts present an evaluation of the liver safety findings observed during the clinical development and their views on the role of these findings in predicting the occurrence of drug-induced liver injury, the benefits of the treatment, the safety and the implications to the current clinical practice.
子宫肌瘤是一种发生在子宫壁内的良性肿瘤，影响着女性的健康。醋酸乌利司他 5 毫克于 2012 年 2 月 23 日首次在欧盟获得批准，迄今为止，其上市后的使用估计已超过 76.5 万名患者。在上市后经验中，偶有报告肝脏损伤和肝功能衰竭的病例。对醋酸乌利司他 5 毫克开发过程中进行的临床试验进行了详细审查，以进一步评估临床试验期间报告的肝脏安全性数据。
对任何研究剂量水平和任何治疗持续时间暴露于醋酸乌利司他的患者的 I 期至 III 期临床数据进行了详细审查，并呈现了肝功能测试值。此外，还提供了关于药物性肝损伤的文献综述。
专家们评估了在临床开发期间观察到的肝脏安全性发现，并就这些发现在预测药物性肝损伤的发生、治疗的益处、安全性以及对当前临床实践的影响方面的作用发表了看法。
