A Clinician's Guide to the Treatment of Endometriosis with Elagolix

Leyland, Nicholas; Estes, Stephanie J.; Lessey, Bruce A.; Advincula, Arnold P.; Taylor, Hugh S.

doi:10.1089/jwh.2019.8096

Cited by 24 publications

(10 citation statements)

References 50 publications

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“…Moreover, according to Wang et al [ 106 ], two recently FDA-approved doses of elagolix for management of moderate-to-severe pain associated with endometriosis (24 months, 150 mg, once daily; and 6 months, 200 mg, twice daily) both proved cost-effective versus leuprolide acetate over a time frame of 1–2 years. Although there are still areas that require further scrutiny in terms of efficacy and safety in real-world populations, potential use of ABT, and comparisons with OCPs and progestins [ 107 ], we agree with Leyland et al [ 108 ] that clinical evidence clearly demonstrates that oral GnRH antagonists are effective and well tolerated in patients with moderate-to-severe endometriosis-associated pain. Of course, studies comparing the efficacy of GnRH antagonists with OCPs and progestins are mandatory.…”

Section: Discussionsupporting

confidence: 75%

GnRH Antagonists with or without Add-Back Therapy: A New Alternative in the Management of Endometriosis?

Donnez

Dolmans

2021

IJMS

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To evaluate the effectiveness of a new class of medical drugs, namely oral gonadotropin-releasing hormone (GnRH) antagonists, in the management of premenopausal women with endometriosis-associated pelvic pain. We reviewed the most relevant papers (n = 27) on the efficacy of new medical alternatives (oral GnRH antagonists) as therapy for endometriosis. We first briefly summarized the concept of progesterone resistance and established that oral contraceptives and progestogens work well in two-thirds of women suffering from endometriosis. Since clinical evidence shows that estrogens play a critical role in the pathogenesis of the disease, lowering their levels with oral GnRH antagonists may well prove effective, especially in women who fail to respond to progestogens. There is a need for reliable long-term oral treatment capable of managing endometriosis symptoms, taking into consideration both the main symptoms and phenotype of the disease. Published studies reviewed and discussed here confirm the efficacy of GnRH antagonists. There is a place for GnRH antagonists in the management of symptomatic endometriosis. Novel algorithms that take into account the different phenotypes are proposed.

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Section: Discussionsupporting

confidence: 75%

GnRH Antagonists with or without Add-Back Therapy: A New Alternative in the Management of Endometriosis?

Donnez

Dolmans

2021

IJMS

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“…Since its approval by the FDA in July 2018, elagolix has become the first GnRH antagonist used for the management and treatment of moderate to severe endometriosisassociated pelvic pain and dysmenorrhea, as well as dyspareunia, due to its high binding affinity for GnRHR, decreased interactions with hepatic P450 enzymes, avoidance of the flare-up effect of the GnRH agonists, and its efficacy in suppressing LH, FSH and E 2 levels. 2,[22][23][24][25]28,[30][31][32] Elagolix is given at doses of 150mg once a day during a 24 monthperiod, causing partial estrogen suppression, and 200 mg twice a day for 6 months, resulting in full estrogen suppression, allowing an adequate and individual control of hypoestrogenic side effects. 4,22,32 The tablet should be taken at approximately the same time, every day, with or without food.…”

Section: Endometriosis and Adenomyosismentioning

confidence: 99%

Gynecological uses of GnRH antagonists: review article

Ruiz¹,

Núñez²,

Núñez-Troconis³

2022

OGIJ

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Aim: to review and analyze the use of gonadotropin-releasing hormone (GnRH) antagonists in endometriosis, adenomyosis, non-menstrual pelvic pain, uterine fibroids, prostate cancer, female infertility, and precocious puberty. Methods: the information used to write this manuscript was obtained during a three-month period, between October and May 2022, from specialized literature, written in English and Spanish, related to the use and potential applications of GnRH antagonists in medicine, mainly published during the last five years, using journals found in the most relevant medical digital archives, including PubMed, SciELO, Google Scholar, Cochrane, and Elsevier. Among the keywords used for obtaining this updated information were gonadotropin-releasing hormone (GnRH) antagonists; GnRH receptors (GnRHR); elagolix; relugolix; cetrorelix; linzagolix; hypothalamic-pituitary-gonadal (HPG) axis; endometriosis; adenomyosis; pelvic pain; uterine fibroids; leiomyomas; infertility; precocious puberty; PP; and central PP. Results: GnRH antagonists induce a rapid onset of clinical effects, without the flare-up effect that is seen with agonists, and have immediate therapeutic effects; once treatment concludes, hormonal suppression rapidly ceases, with normalization of gonadal function within a few days, guaranteeing an increase of GnRH concentration, controlling non-menstrual pelvic pain and heavy menstrual bleeding, and serving as part of the treatment of infertility and precocious puberty. Conclusion: even though the aforementioned gynecological pathologies can be treated with the use of multiple drugs, GnRH antagonists have shown to be potential first lines of treatment, as long as their administration protocols are followed correctly.

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“…In the case of surgical treatment, pharmacotherapies aimed at the reduction of leiomyoma and uterine volume or improvement of anemia are also introduced before the surgical treatment to conduct less invasive surgery(i.e., to reduce blood loss or surgical duration). However, the clinician often encounters cases in which menopausal symptoms are thought to be drug-related at about eight weeks after the beginning of treatment, making it di cult to continue treatment [14]. And by the phase III trial designed for relugolix administration to patients with leiomyoma, the leiomyoma volume as a secondary endpoint reduced by 43.28±33.85% by 12 weeks and 49.75±34.33% by 24 weeks of administration compared with the baseline.…”

Section: Introductionmentioning

confidence: 99%

The clinical trial of alternative Relugolix administration for uterine leiomyoma prior to surgically treatment: a study protocol for Non-Adverse Relugolix Administration (NARA) trial

Kawahara,

Kawaguchi,

Yamamoto

et al. 2023

Preprint

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Background: Uterine leiomyomas are common for reproductive-aged women and affect women’s quality of life due to heavy menstrual bleeding or dysmenorrhea. Leiomyomas grow according to estradiol exposure and decrease after post-menopause. In case serious symptoms are caused by leiomyomas, pharmacotherapy or surgical treatment is proposed. Prior to surgical treatment, pharmacotherapies aimed at reduction of leiomyoma and uterine volume or improvement of anemia are introduced to conduct minimum invasive surgery(i.e., to reduce blood loss or surgical duration). Recently relugolix(40mg orally once daily) as a gonadotropin-releasing hormone (GnRH) receptor antagonist has proved its sufficient efficacy in suppressing estradiol levels without the transient estradiol flare-up compared with GnRH agonist. However long-term administration should not be permitted liable to for climacteric disorder or osteoporosis. And evidence is lacking on the actual efficacy and extent of adverse effects of the every other day dosing regimen. This trial aimed to prove non-inferiority in volume reduction effect on leiomyoma and safety(i.e., reduction of adverse effects) by every other day administration after two months of everyday administration compared to daily administration throughout the duration. Methods: A minimization adaptive randomized control trial(RCT) will be conducted. Patients(over 20 years old) harboring leiomyoma who will be undergoing surgical treatment will be invited to participate. Patients who are enrolled in the intervention group will receive every other day administration for 16 weeks after eight weeks of daily administration. Patients who are enrolled in the control group will receive daily throughout the 24 weeks. The primary outcome is the leiomyoma volume change rate and the secondary endpoints are the change rate of uterine volume, the occurrence of the climacteric disorder, genital bleeding days, change rate of serum hormone or bone turnover markers, and bone mineral density after 24 weeks compared to before administration. Discussion: This study will aim to prove both the non-inferiority in leiomyoma volume reduction and superiority in adverse effects occurrence reduction, which will provide a novel method to escape adverse effects with maintaining the effect of leiomyoma reduction. Trial registration: jRCTs051230078, registered 26 July 2023.

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A Clinician's Guide to the Treatment of Endometriosis with Elagolix

Cited by 24 publications

References 50 publications

GnRH Antagonists with or without Add-Back Therapy: A New Alternative in the Management of Endometriosis?

GnRH Antagonists with or without Add-Back Therapy: A New Alternative in the Management of Endometriosis?

Gynecological uses of GnRH antagonists: review article

The clinical trial of alternative Relugolix administration for uterine leiomyoma prior to surgically treatment: a study protocol for Non-Adverse Relugolix Administration (NARA) trial

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