Clinical Utility Of Elagolix As An Oral Treatment For Women With Uterine Fibroids: A Short Report On The Emerging Efficacy Data.
elagolix
heavy menstrual bleeding
leiomyomas
non-peptide GnRH antagonist
uterine fibroids
Journal
International journal of women's health
ISSN: 1179-1411
Titre abrégé: Int J Womens Health
Pays: New Zealand
ID NLM: 101531698
Informations de publication
Date de publication:
2019
2019
Historique:
received:
05
05
2019
accepted:
09
10
2019
entrez:
8
11
2019
pubmed:
7
11
2019
medline:
7
11
2019
Statut:
epublish
Résumé
Uterine fibroids (UFs) are the most common gynaecological benign disease. Even though often asymptomatic, UFs can worsen women's health and their quality of life, causing heavy bleeding and anaemia, pelvic discomfort and reduced fertility. Surgical treatment of UFs could be limited by its invasiveness and the desire to preserve fertility. Thus, effective medical therapies for the management of this condition are needed. Common drugs used to control bleeding, such us hormonal contraceptive or levonorgestrel-releasing intrauterine system, have no effect on fibroids volume. Among other more efficient treatments, the gonadotropin-releasing hormone (GnRH) agonist or the selective progesterone-receptor modulators have a non-neutral safety profile; thus, they are used for limited periods or for cyclic treatments. Elagolix is a potent, orally bioavailable, non-peptide GnRH antagonist that acts by a competitive block of the GnRH receptor. The biological effect is a dose-dependent inhibition of gonadal axis, without a total suppression of estradiol concentrations. For this reason, even though comparative studies between elagolix and GnRH agonists have not been performed, elagolix has been associated with a better profile of adverse events. Recently, elagolix received US FDA approval for the treatment of moderate to severe pain caused by endometriosis. Several clinical trials assessed the efficacy of elagolix for the treatment of heavy bleeding caused by UFs and the definitive results of Phase III studies are expected. Available data on elagolix and UFs showed that the drug, with or without low-dose hormone add-back therapy, is able to significantly reduce menstrual blood loss, lead to amenorrhea and improve haemoglobin concentrations in the majority of participants in comparison with placebo. The safety and tolerability profile appeared generally acceptable. The concomitant use of add-back therapy can prevent bone loss due to the hypoestrogenic effect and can improve safety during elagolix treatment.
Identifiants
pubmed: 31695514
doi: 10.2147/IJWH.S185023
pii: 185023
pmc: PMC6815212
doi:
Types de publication
Journal Article
Review
Langues
eng
Pagination
535-546Informations de copyright
© 2019 Neri et al.
Déclaration de conflit d'intérêts
The authors report no conflicts of interest in this work.
Références
Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:32-37
pubmed: 30099225
PLoS One. 2017 Mar 7;12(3):e0173523
pubmed: 28267814
Cochrane Database Syst Rev. 2015 Mar 20;(3):CD010854
pubmed: 25793972
Curr Med Res Opin. 2017 Nov;33(11):1971-1978
pubmed: 28836862
Expert Opin Investig Drugs. 2018 May;27(5):497-505
pubmed: 29718788
Clin Obstet Gynecol. 2016 Mar;59(1):30-52
pubmed: 26756261
Arch Gynecol Obstet. 2013 Jul;288(1):139-48
pubmed: 23553194
Int J Womens Health. 2019 Jul 05;11:387-394
pubmed: 31308763
Reprod Biomed Online. 2010 Nov;21(5):610-5
pubmed: 20880745
PLoS One. 2012;7(5):e36935
pubmed: 22570742
Am J Obstet Gynecol. 2013 Oct;209(4):319.e1-319.e20
pubmed: 23891629
Hum Reprod. 2010 Feb;25(2):418-29
pubmed: 19910322
Hum Reprod Update. 2016 Nov;22(6):665-686
pubmed: 27466209
Curr Opin Obstet Gynecol. 2011 Aug;23(4):238-44
pubmed: 21666463
Molecules. 2017 Dec 09;22(12):null
pubmed: 29232843
J Med Chem. 2008 Dec 11;51(23):7478-85
pubmed: 19006286
Curr Opin Obstet Gynecol. 2018 Aug;30(4):243-251
pubmed: 29939852
Cochrane Database Syst Rev. 2013 Oct 23;(10):CD009505
pubmed: 24151065
Curr Med Res Opin. 2017 Feb;33(2):193-200
pubmed: 27733082
Maturitas. 2014 Sep;79(1):106-16
pubmed: 24975954
BJOG. 2017 Sep;124(10):1501-1512
pubmed: 28296146
Fertil Steril. 2010 Jan;93(1):192-8
pubmed: 19135657
Endocrinology. 2000 Oct;141(10):3852-61
pubmed: 11014242
Fertil Steril. 1996 Apr;65(4):707-10
pubmed: 8654625
Drug Des Devel Ther. 2014 Feb 20;8:285-92
pubmed: 24591818
N Engl J Med. 2012 Feb 2;366(5):409-20
pubmed: 22296075
Best Pract Res Clin Obstet Gynaecol. 2016 Jul;34:74-84
pubmed: 26723475
N Engl J Med. 2013 Oct 3;369(14):1344-55
pubmed: 24088094
Am J Obstet Gynecol. 1996 Feb;174(2):654-8
pubmed: 8623802
Fertil Steril. 2011 Jan;95(1):9-12
pubmed: 20883986
Fertil Steril. 2017 Jul;108(1):152-160.e4
pubmed: 28579415
N Engl J Med. 2017 Jul 6;377(1):28-40
pubmed: 28525302
Curr Obstet Gynecol Rep. 2016;5(4):318-324
pubmed: 27917310
J Clin Endocrinol Metab. 2009 Feb;94(2):545-51
pubmed: 19033369
Obstet Gynecol. 2017 Dec;130(6):1251-1260
pubmed: 29112659
Drugs. 2019 Apr;79(6):675-679
pubmed: 30937733
Fertil Steril. 2016 Jan;105(1):165-173.e4
pubmed: 26477496
Obstet Gynecol. 2018 Jul;132(1):147-160
pubmed: 29889764
Am J Obstet Gynecol. 2012 Mar;206(3):211.e1-9
pubmed: 22244472
Eur J Obstet Gynecol Reprod Biol. 2009 Jul;145(1):14-21
pubmed: 19398260
Science. 1965 Oct 1;150(3692):67-9
pubmed: 5833538
Cochrane Database Syst Rev. 2001;(2):CD000547
pubmed: 11405968
Fertil Steril. 1989 Jun;51(6):951-6
pubmed: 2498132
Eur J Obstet Gynecol Reprod Biol. 2013 Dec;171(2):329-32
pubmed: 24103533
Int J Mol Sci. 2017 Dec 01;18(12):null
pubmed: 29194370
Reprod Biomed Online. 2001;3(1):14-18
pubmed: 12513885
Drugs. 2018 Sep;78(14):1501-1508
pubmed: 30194661
J Clin Endocrinol Metab. 2017 May 1;102(5):1683-1691
pubmed: 28323948
Steroids. 2014 Aug;86:69-78
pubmed: 24832215
Obstet Gynecol. 1998 Jan;91(1):16-24
pubmed: 9464714
Fertil Steril. 2011 Nov;96(5):1175-89
pubmed: 21944187
BJOG. 2005 May;112(5):638-42
pubmed: 15842290
Best Pract Res Clin Obstet Gynaecol. 2016 Jul;34:66-73
pubmed: 26856931
Eur J Obstet Gynecol Reprod Biol. 2010 Sep;152(1):96-102
pubmed: 20598796
N Engl J Med. 2015 Apr 23;372(17):1646-55
pubmed: 25901428
Reprod Sci. 2014 Nov;21(11):1341-51
pubmed: 25249568
Endocrinology. 2010 Jun;151(6):2433-42
pubmed: 20375184
Obstet Gynecol. 2018 Nov;132(5):1252-1264
pubmed: 30303923
Hum Reprod Update. 2005 May-Jun;11(3):293-307
pubmed: 15790602
Clin Pharmacol Drug Dev. 2019 Nov;8(8):1053-1061
pubmed: 30570832
N Engl J Med. 2012 Feb 2;366(5):421-32
pubmed: 22296076
Acta Obstet Gynecol Scand. 2010 Nov;89(11):1438-46
pubmed: 20955098
Obstet Gynecol Clin North Am. 2006 Mar;33(1):59-67
pubmed: 16504806
Expert Opin Drug Metab Toxicol. 2016 May;12(5):581-8
pubmed: 27021205