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REVISTA DE CHIMIE
Cite as: Rev. Chim.
https://doi.org/10.37358/Rev.Chim.1949

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Revista de Chimie (Rev. Chim.), Year 2018, Volume 69, Issue 8,

https://doi.org/10.37358/RC.18.8.6456

Liana Ples, Cringu Ionescu, Mihai Dimitriu, Anca Lesnic, Zorela Adriana Sgarbura, Alina Calin

Is Ulipristal Acetate a Liver Toxic Biomolecule? Toxicity assessment of ulipristal acetate


Abstract:

Progesterone is an endogenous steroid and progestogen sex hormone involved in the menstrual cycle, pregnancy, and embryogenesis of humans and other species. Its main functions are playing a key role in the development, differentiation, and normal functioning of female reproduction-related target tissues including the uterus (endometrium and myometrium), the ovary, and the mammary gland, as well as regulating the hypothalamic-pituitary-gonadal axis. Soon after the discovery of the progesterone receptor (PR) it was appreciated that the development of a PR antagonist would have a major therapeutic potential. Numerous related compounds have been synthesized exhibiting a spectrum of activity ranging from pure progesterone receptor antagonists (PA), to mixed agonists/antagonists. These latter compounds are also known as selective progesterone receptor modulators (SPRM), progesterone receptor modulators (PRM), mesoprogestins or partial agonist-antagonists. Ulipristal acetate is a SPRM used in Europe for preoperative treatment of moderate-to-severe symptoms of uterine leiomyomas in adult women of reproductive age. This is a retrospective cohort study conducted in two medical units, Saint John Hospital and Egometacs Clinic, between january 2017-december 2018, on women treated with UPA (ulipristal acetate) for symptomatic uterine fibroids, in order to evaluate if there were any liver function changes after the treatment. In the mentioned period, 74 women were treated with UPA for symptomatic uterine myomas in the two units. After checking the records, 6 women were lost on follow up (only the first visit was recorded), 4 didn’t complete the treatment course and 7 had incomplete laboratory evaluation, either at the beginning or at the end of treatment. Finally, our cohort was comprised of 57 women, aged between 20 and 50 years old, treated with UPA for various conditions (myomas, abnormal bleeding, pelvic pain etc.) during a period of 3 month’, and adherence to treatment was 100%. We performed a paired T-test on the before and after values of the AST, ALT, GGT enzymes and total bilirubin levels, for our statistical analysis we used SPPS 20, and the charts were built using Microsoft Excel. There were no significant statistical differences between the before and after values of the variables measured in our study. In our study the paired T-test determined that there were no statistical significant differences between the liver function after Esmya administration. Altough there was no evidence of hepatic impairment in the 3 months course of treatment, precautions as the one recomended by EMA, should be respected. Still, more studies are needed in order to rule out the potential harmful effect of UPA on the liver, taking into account detailed liver function evaluation and extended laboratory tests. Until then, the temporary safety measures issued by the European Medicines Agency, are to be respected. The measures include: no use of UPA for women with known liver conditions, careful monitoring of liver function monthly for the patients under treatment and at four weeks after, and immediate discontinuation and report of any adverse complaints.
Keywords:
progesterone; ulipristal acetate; selective progesterone receptor modulators; leiomyoma

Issue: 2018, Volume 69, Issue 8
Pages:
Publication date: 2018/9/15
https://doi.org/10.37358/RC.18.8.6456
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Creative Commons License
This article is published under the Creative Commons Attribution 4.0 International License
Citation Styles
Cite this article as:
PLES, L., IONESCU, C., DIMITRIU, M., LESNIC, A., SGARBURA, Z.A., CALIN, A., Is Ulipristal Acetate a Liver Toxic Biomolecule? Toxicity assessment of ulipristal acetate
, Rev. Chim., 69(8), 2018, 1972-0.

Vancouver
Ples L, Ionescu C, Dimitriu M, Lesnic A, Sgarbura ZA, Calin A. Is Ulipristal Acetate a Liver Toxic Biomolecule? Toxicity assessment of ulipristal acetate
. Rev. Chim.[internet]. 2018 Aug;69(8):. Available from: https://doi.org/10.37358/RC.18.8.6456


APA 6th edition
Ples, L., Ionescu, C., Dimitriu, M., Lesnic, A., Sgarbura, Z.A. & Calin, A. (2018). Is Ulipristal Acetate a Liver Toxic Biomolecule? Toxicity assessment of ulipristal acetate
. Revista de Chimie, 69(8), . https://doi.org/10.37358/RC.18.8.6456


Harvard
Ples, L., Ionescu, C., Dimitriu, M., Lesnic, A., Sgarbura, Z.A., Calin, A. (2018). 'Is Ulipristal Acetate a Liver Toxic Biomolecule? Toxicity assessment of ulipristal acetate
', Revista de Chimie, 69(8), pp. . https://doi.org/10.37358/RC.18.8.6456


IEEE
L. Ples, C. Ionescu, M. Dimitriu, A. Lesnic, Z.A. Sgarbura, A. Calin, "Is Ulipristal Acetate a Liver Toxic Biomolecule? Toxicity assessment of ulipristal acetate
". Revista de Chimie, vol. 69, no. 8, pp. , 2018. [online]. https://doi.org/10.37358/RC.18.8.6456


Text
Liana Ples, Cringu Ionescu, Mihai Dimitriu, Anca Lesnic, Zorela Adriana Sgarbura, Alina Calin,
Is Ulipristal Acetate a Liver Toxic Biomolecule? Toxicity assessment of ulipristal acetate
,
Revista de Chimie,
Volume 69, Issue 8,
2018,
Pages 1972-0,
ISSN 2668-8212,
https://doi.org/10.37358/RC.18.8.6456.
(https://revistadechimie.ro/Articles.asp?ID=6456)
Keywords: progesterone; ulipristal acetate; selective progesterone receptor modulators; leiomyoma


RIS
TY - JOUR
T1 - Is Ulipristal Acetate a Liver Toxic Biomolecule? Toxicity assessment of ulipristal acetate

A1 - Ples, Liana
A2 - Ionescu, Cringu
A3 - Dimitriu, Mihai
A4 - Lesnic, Anca
A5 - Sgarbura, Zorela Adriana
A6 - Calin, Alina
JF - Revista de Chimie
JO - Rev. Chim.
PB - Revista de Chimie SRL
SN - 2668-8212
Y1 - 2018
VL - 69
IS - 8
SP - 1972
EP - 0
UR - https://doi.org/10.37358/RC.18.8.6456
KW - progesterone
KW - ulipristal acetate
KW - selective progesterone receptor modulators
KW - leiomyoma
ER -


BibTex
@article{RevCh2018P1972,
author = {Ples Liana and Ionescu Cringu and Dimitriu Mihai and Lesnic Anca and Sgarbura Zorela Adriana and Calin Alina},
title = {Is Ulipristal Acetate a Liver Toxic Biomolecule? Toxicity assessment of ulipristal acetate
},
journal = {Revista de Chimie},
volume = {69},
number = {8},
pages = {},
year = {2018},
issn = {2668-8212},
doi = {https://doi.org/10.37358/RC.18.8.6456},
url = {https://revistadechimie.ro/Articles.asp?ID=6456}
}
 
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