Long-Term Outcomes of Elagolix in Women With Endometriosis

Surrey, Eric S.; Taylor, Hugh S.; Giudice, Linda C.; Lessey, Bruce A.; Abrão, Maurício Simões; Archer, David F.; Diamond, Michael P.; Johnson, Neil; Watts, Nelson B.; Gallagher, J. Christopher; Simon, James A.; Carr, Bruce R.; Dmowski, W. Paul; Leyland, Nicholas; Singh, Sukhbir S.; Rechberger, Tomasz; Agarwal, Sanjay; Duan, W. Rachel; Schwefel, B.; Thomas, James W.; Peloso, Paul M.; Ng, Juki; Soliman, Ahmed M.; Chwalisż, Kristof

doi:10.1097/aog.0000000000002675

Cited by 103 publications

(89 citation statements)

References 19 publications

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“…Elagolix demonstrated an exposure-response relationship with hormonal changes, as well as primary efficacy (DYS and NMPP) and safety (BMD changes) endpoints. Since the BMD changes observed with elagolix were time-dependent [4,27], the exposure-BMD model enabled simulations of various durations of treatment that ultimately supported the 24 months' approved duration of use with 150 mg once daily with no coexisting conditions (dyspareunia or Child-Pugh B). Overall, the full characterization of the elagolix clinical pharmacology profile and the model-based analyses played a critical role in the approval of elagolix as the first oral GnRH receptor antagonist for the management of moderate to severe pain associated with endometriosis [1].…”

Section: Discussionmentioning

confidence: 99%

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Clinical Pharmacology of Elagolix: An Oral Gonadotropin-Releasing Hormone Receptor Antagonist for Endometriosis

et al. 2019

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The clinical pharmacology of elagolix was extensively evaluated in clinical studies in healthy subjects and in women with endometriosis. Elagolix pharmacokinetics (PK) show significant population variability, however they are minimally affected by patients' baseline characteristics and demographics, except for clinically relevant extrinsic and intrinsic factors such as coadministrated strong organic anion transporting polypeptide (OATP) 1B1 inhibitors and severe hepatic impairment, which are contraindications for the use of elagolix. These studies enabled a comprehensive understanding of elagolix mechanism of action and the downstream pharmacodynamic (PD) effects on gonadotropin and ovarian hormones, as well as full characterization of the PK/PD (PKPD) relationships of elagolix at various dosages, including the approved 150 mg once daily and 200 mg twice daily dosing regimens for the management of moderate to severe pain associated with endometriosis. Several model-based analyses have contributed to understanding of the benefit-risk profile of elagolix in patients with endometriosis, through characterization of the exposure relationship with responder rates, with changes in bone mineral density over time, as well as the interaction with coadministered drugs. Collectively, these studies and analyses served as supportive evidence for the effectiveness of the approved dosages and provided general dosing instructions of the first approved oral gonadotropin-releasing hormone receptor antagonist.

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Section: Discussionmentioning

confidence: 99%

“…Summary statistics of predicted percentage change from baseline in lumbar spine bone mineral density following treatment with elagolix 150 mg qd or 200 mg bid for 36 months bid twice daily, BMD bone mineral density, CI confidence interval, NA not available, qd once daily a Mean from each phase III study[4,27] …”

mentioning

confidence: 99%

Clinical Pharmacology of Elagolix: An Oral Gonadotropin-Releasing Hormone Receptor Antagonist for Endometriosis

et al. 2019

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“…In a randomized, blinded, placebo-controlled trial, GnRH antagonist therapy was found to decrease dysmenorrhea and nonmenstrual pelvic pain. 50,51 Reduction of dysmenorrhea was more pronounced than the effect on intermenstrual pain symptoms. 50 Newer GnRH antagonists have the benefit of oral administration and reduction in side effects.…”

Section: Hormonal Modulationmentioning

confidence: 97%

Opioids and Alternatives in Female Chronic Pelvic Pain

Valentine

Deimling

2018

Semin Reprod Med

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Chronic pelvic pain is a complex condition with peripheral and central mechanisms of pain. Successful nonsurgical management typically relies on a multimodal approach, with integration of both pharmacologic and nonpharmacologic interventions. This article reviews nonpharmacologic therapies including pelvic floor physical therapy, dietary modifications, psychotherapy, and acupuncture. These interventions are low risk and should be incorporated into treatment for chronic pelvic pain, as they show promise for successful symptom relief in many overlapping chronic pain conditions. Common nonopioid medications for pelvic are also reviewed, including analgesics, hormone modulating agents, antidepressants, and anticonvulsants. Guidelines for cautious and responsible opioid use are also summarized. While data specific to chronic pelvic pain management remain limited, evidence supporting treatment of other chronic pain conditions is reviewed to help guide management.

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“…Currently, there are no reliable non-invasive biomarker tests available in clinical practice that diagnose endometriosis and using any non-invasive tests should only be undertaken in a research setting. 36,37 Imaging Accurate and timely diagnosis of pelvic endometriosis is crucial to guarantee patients are given the best treatment strategies. The most commonly used imaging techniques to identify and characterize endometriosis lesions are Transvaginal sonography (TVS) and magnetic resonance imaging (MRI).…”

Section: Clinical Assessmentmentioning

confidence: 99%

<p>Bowel Endometriosis: Current Perspectives on Diagnosis and Treatment</p>

Habib¹,

Centini²,

Lazzeri³

et al. 2020

IJWH

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Endometriosis is a chronic condition primarily affecting young women of reproductive age. Although some women with bowel endometriosis may be asymptomatic patients typically report a myriad of symptoms such as alteration in bowel habits (constipation/diarrhoea) dyschezia, dysmenorrhoea and dyspareunia in addition to infertility. To date, there are no clear guidelines on the evaluation of patients with suspected bowel endometriosis. Several techniques have been proposed including transvaginal and/or transrectal ultrasonography, magnetic resonance imaging, and double-contrast barium enema. These different imaging modalities provide greater information regarding presence, location and extent of endometriosis ensuring patients are adequately informed whilst also optimizing preoperative planning. In cases where surgical management is indicated, surgery should be performed by experienced surgeons, in centres with access to multidisciplinary care. Treatment should be tailored according to patient symptoms and wishes with a view to excising as much disease as possible, whilst at the same time preserving organ function. In this review article current perspectives on diagnosis and management of bowel endometriosis are discussed.

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Long-Term Outcomes of Elagolix in Women With Endometriosis

Abstract: ClinicalTrials.gov, NCT01760954 and NCT02143713.

Cited by 103 publications

References 19 publications

Clinical Pharmacology of Elagolix: An Oral Gonadotropin-Releasing Hormone Receptor Antagonist for Endometriosis

Clinical Pharmacology of Elagolix: An Oral Gonadotropin-Releasing Hormone Receptor Antagonist for Endometriosis

Opioids and Alternatives in Female Chronic Pelvic Pain

<p>Bowel Endometriosis: Current Perspectives on Diagnosis and Treatment</p>

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