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Article Dans Une Revue Expert Opinion on Drug Safety Année : 2018

Liver safety parameters of ulipristal acetate for the treatment of uterine fibroids: a comprehensive review of the clinical development program

Résumé

Introduction: 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. Areas covered: 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 Expert opinion: 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 druginduced liver injury, the benefits of the treatment, the safety and the implications to the current clinical practice.
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Dates et versions

hal-03179925 , version 1 (24-03-2021)

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Jacques Donnez, Arriagada Pablo, Dominique Larrey. Liver safety parameters of ulipristal acetate for the treatment of uterine fibroids: a comprehensive review of the clinical development program. Expert Opinion on Drug Safety, 2018, 17 (12), pp.1225 - 1232. ⟨10.1080/14740338.2018.1550070⟩. ⟨hal-03179925⟩
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