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Clinical Utility of Elagolix As an Oral Treatment for Women with Uterine Fibroids: a Short Report on the Emerging Efficacy Data

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Clinical Utility of Elagolix As an Oral Treatment for Women with Uterine Fibroids: a Short Report on the Emerging Efficacy Data International Journal of Women's Health Dovepress open access to scientific and medical research Open Access Full Text Article REVIEW Clinical Utility Of Elagolix As An Oral Treatment For Women With Uterine Fibroids: A Short Report On The Emerging Efficacy Data This article was published in the following Dove Press journal: International Journal of Women's Health – Manuela Neri 1 3 Abstract: Uterine fibroids (UFs) are the most common gynaecological benign disease. Even – Gian Benedetto Melis 1 3 though often asymptomatic, UFs can worsen women’s health and their quality of life, – Elena Giancane1 3 causing heavy bleeding and anaemia, pelvic discomfort and reduced fertility. Surgical – Valerio Vallerino 1 3 treatment of UFs could be limited by its invasiveness and the desire to preserve fertility. – Monica Pilloni 1 3 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 Bruno Piras 1 3 – intrauterine system, have no effect on fibroids volume. Among other more efficient treat- Alessandro Loddo1 3 1–3 ments, the gonadotropin-releasing hormone (GnRH) agonist or the selective progesterone- Anna Maria Paoletti fi – receptor modulators have a non-neutral safety pro le; thus, they are used for limited periods Valerio Mais 1 3 For personal use only. or for cyclic treatments. Elagolix is a potent, orally bioavailable, non-peptide GnRH antago- 1Department of Obstetrics and nist that acts by a competitive block of the GnRH receptor. The biological effect is a dose- Gynaecology, University of Cagliari, Italy; dependent inhibition of gonadal axis, without a total suppression of estradiol concentrations. 2Department of Surgical Sciences, University of Cagliari, Italy; 3Maternal For this reason, even though comparative studies between elagolix and GnRH agonists have Child Department, University Hospital of not been performed, elagolix has been associated with a better profile of adverse events. Cagliari, Italy 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 International Journal of Women's Health downloaded from https://www.dovepress.com/ by 93.65.147.59 on 24-Oct-2019 effect and can improve safety during elagolix treatment. Keywords: uterine fibroids, leiomyomas, elagolix, non-peptide GnRH antagonist, heavy menstrual bleeding Introduction Uterine fibroids (UFs), also known as uterine myomas or leiomyomas, are the most Correspondence: Manuela Neri Department of Obstetrics and frequent gynaecological benign disease. Establishing the real prevalence of this Gynaecology, Department of Surgical Sciences, University of Cagliari, Maternal condition is complex because, very often, they develop without any sign or Child Department, University Hospital of symptoms. A recent epidemiological study estimated that the prevalence of UFs Cagliari, Policlinico Universitario Duilio 1 Casula, SS 554 – bivio Sestu, blocco Q, reaches the 70% of women, with an age-dependent increase of the incidence. The Monserrato, Cagliari 09042, Italy black race is considered the main risk factor, as it increases UFs appearance by two- Tel +39 333 8867567 Email [email protected] threefold compared with the white race. Among other secondary risk factors, submit your manuscript | www.dovepress.com International Journal of Women's Health 2019:11 535–546 535 DovePress © 2019 Neri et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php – http://doi.org/10.2147/IJWH.S185023 and incorporate the Creative Commons Attribution Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Powered by TCPDF (www.tcpdf.org) 1 / 1 Neri et al Dovepress conditions associated with increased ovarian steroids solves the problem of UFs and their recurrence risk,12 exposure, such as early menarche, nulliparity or first preg- for its invasiveness it should be considered in symptomatic nancy delayed in late age, are to be included.1–3 Despite women that do not wish to give birth and agree with a the high prevalence, UFs become symptomatic, sometimes surgical approach.13 To preserve fertility, conservative seriously, in only 15–30% of cases.2 Symptoms linked to treatment such as myomectomy could be considered. In myomas can depend on their localization in the uterus: this case, the laparoscopic approach showed a more favor- submucosal fibroids are more likely related to heavy men- able fertility rate after surgery compared to the abdominal, strual bleeding (HMB) and anaemia, whereas subserosal with lower morbidity and shorter hospitalization after fibroids can cause compressive symptoms such as pain, surgery.14 However, when myomas are numerous, large dysuria, tenesmus or constipation.2 Not surprisingly, UFs or deep in the myometrium, laparoscopy becomes more may also affect reproduction and fertility in different difficult and may require the use of morcellation or mini- ways: by altering the endometrial cavity and its perfusion, laparotomy to remove the lesions.13,15 As a small, but not by reducing implantation or by affecting endocrine and irrelevant, risk of disseminating an occult sarcoma exists paracrine molecular mechanisms involved in embryonic during fibroids extraction procedures, the Food and Drug – development.4 6 Moreover, the presence of fibroids has Administration warns against using morcellation.16 been linked to adverse pregnancy outcomes, such as Containment systems like endoscopic bags are now avail- increased risk of spontaneous abortion, foetal malpresenta- able for both electrical and manual morcellation.17 For tion, placenta previa, preterm birth, caesarean section, and sub-mucous fibroids, hysteroscopic myomectomy is the peripartum haemorrhage.7 Last but not least, medical lit- treatment of choice to improve bleeding and to normalize erature reports a lot of evidence that UFs and related the uterine cavity.18 In selective cases of UFs associated to symptoms negatively affect women’s quality of life metrorrhagia, in women who do not wish to preserve (QoL). Cross-national surveys demonstrated that more fertility, a treatment option could be also hysteroscopic than 60% of women with leiomyomas present a moderate endometrial ablation.12,13 In different contexts, such as For personal use only. to very important impact of fibroids on quality of life,8 and strongly symptomatic and voluminous myomas, surgical work productivity and general activity are reduced by treatment of UFs represents the gold standard. more than 35%.9 Common UFs symptoms affecting Nevertheless, alternatives to surgery are necessary because health-related QoL are lower back pain (65%), fatigue of its invasiveness, its cost and its reproductive conse- (63%), bloating (61%), pelvic pain/cramping during quences. Last but not least, it must be considered that menses (63%), and HMB (54%).10 As a consequence of many women often prefer not to undergo surgery.19 the great prevalence, the chronicity of the condition, the Lately, non-surgical physical treatments for UFs have burden of the symptoms and the impact on daily life, UFs been developed. The uterine artery embolization is a per- imply a considerable cost for both patients and health care cutaneous catheterization technique that causes a selective systems, which has been estimated to be greater than that necrosis of the fibroids, preserving the healthy myome- of some malign diseases such as ovarian or breast cancer.11 trium that has the capacity to revascularize itself. This International Journal of Women's Health downloaded from https://www.dovepress.com/ by 93.65.147.59 on 24-Oct-2019 For this reason, medical research has invested and is minimally invasive procedure has the advantages that it investing heavily in the development of efficient treatment can act at the same time on several lesions and it is for the UFs. There is a general consensus not to treat associated with short hospitalization and rapid recovery myomas when they do not cause symptoms. In all other times. On the other hand, the procedure causes sometimes case, the treatment of UFs can take advantage of surgery, severe abdominal pain and has the risk of pelvic infection medical therapies or physical treatments, and each or incomplete infarction that requires a further interven- approach presents different pros and cons. The manage- tion. Moreover, the effects on reproductive outcomes are ment must consider clinical manifestation, leiomyomas not defined, so it cannot
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