Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas

Simon, James A.; Al-Hendy, Ayman; Archer, David F.; Barnhart, Kurt T.; Bradley, Linda D.; Carr, Bruce R.; Dayspring, Thomas; Feinberg, Eve C.; Gillispie, Veronica; Hurtado, Silvia; Kim, Jinhee; Liu, Ran; Owens, Charlotte D.; Muneyyirci-Delale, Ozgul; Wang, Alice; Watts, Nelson B.; Schlaff, William D.

doi:10.1097/01.ogx.0000696612.60869.1b

Cited by 8 publications

(39 citation statements)

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“…Of note, in the 12-month study (6-month extension), the authors reported that 87.9% of the women taking elagolix with hormonal add-back therapy met the primary objective. 4 Among the women taking elagolix alone, 89.4% met the primary objective.…”

Section: The Extension Trial Resultsmentioning

confidence: 99%

“…ata from the Elaris UF-1 and UF-2 6-month, phase 3 trials 3 and the results of the Elaris UF-EXTEND trial with a 6-month extension (totaling 12 months of use) 4 were published in 2020, and the 12-month results were discussed in OBG Management (2020;32[7]:35, 39-40). An additional data analysis from the same researchers assessed the effect of elagolix with hormonal add-back therapy in a number of patient subgroups.…”

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confidence: 99%

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2021 Update on abnormal uterine bleeding

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2021

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Section: The Extension Trial Resultsmentioning

confidence: 99%

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confidence: 99%

2021 Update on abnormal uterine bleeding

Sharp¹

2021

OBGM

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“…Further reductions in BMD were observed in long-term extension studies; 66 however, BMD was generally similar to or improved with respect to on-treatment values in patients with posttreatment measurements. 61,62,66,67 In head-to-head comparisons, changes in lumbar spine BMD were similar during 24 weeks of treatment with elagolix 150 mg once daily, elagolix 75 mg twice daily, or DMPA (104 mg/0.65 mL administered on weeks 1 and 12) 61 and greater during 12 weeks of treatment with monthly depot leuprolide acetate 3.75 mg compared with elagolix 150 or 250 mg once daily (Table 3). 68 The difference in BMD reduction with leuprolide was attributed to greater estradiol suppression; on-treatment estradiol concentrations were significantly lower with leuprolide versus elagolix (median, 5 and 32 mg, respectively; p < 0.001).…”

Section: Gnrh Antagonistsmentioning

confidence: 95%

“…Add-back therapy has proved effective for mitigating hypoestrogenic effects associated with GnRH antagonists, including changes in BMD (Table 3). 64,65,67,69 At month 6 in 2 identical, phase 3, randomized, placebo-controlled clinical trials of elagolix in women with heavy menstrual bleeding and uterine fibroids, differences in BMD reduction at most measured sites were statistically significant for elagolix 300 mg twice daily alone compared with placebo ( p < 0.05), whereas changes from baseline in mean BMD in patients receiving elagolix 300 mg twice daily plus add-back therapy (1.0 mg estradiol/0.5 mg norethindrone acetate) were similar to the placebo group. 65 Patients enrolled in these phase 3 trials had the option of continuing treatment with elagolix or elagolix plus add-back therapy in a 6-month extension study.…”

Section: Gnrh Antagonistsmentioning

confidence: 99%

Bone Mineral Density Changes Associated With Pregnancy, Lactation, and Medical Treatments in Premenopausal Women and Effects Later in Life

Watts

Binkley

Owens

et al. 2021

Journal of Women's Health

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Bone mineral density (BMD) changes during the life span, increasing rapidly during adolescence, plateauing in the third decade of life, and subsequently entering a phase of age-related decline. In women, menopause leads to accelerated bone loss and an increase in fracture risk. Between peak bone mass attainment and menopause, BMD is generally stable and the risk of fracture is typically low. This time period is marked by life events such as pregnancy and lactation, which transiently decrease BMD, yet their long-term effects on fracture risk are less certain. BMD may also be altered by exposure to medications that affect bone metabolism (e.g., contraceptives, glucocorticoids, antidiabetic medications, antiepileptic drugs). Although oral contraceptives are often believed to be neutral with regard to bone health, depot medroxyprogesterone acetate (DMPA) and gonadotropinreleasing hormone (GnRH) agonists have been associated with decreases in BMD. Development of newer medical therapies, principally GnRH antagonists (e.g., ASP1707, elagolix, linzagolix, relugolix), for treatment of endometriosis-associated pelvic pain and heavy menstrual bleeding due to uterine fibroids has renewed interest in the short-and long-term impacts of changes in BMD experienced by premenopausal women. It is important to understand how these drugs influence BMD and put the findings into context with regard to measurement variability and naturally occurring factors that influence bone health. This review summarizes what is known about the effects on bone health pregnancy, lactation, and use of DMPA, GnRH agonists, and GnRH antagonists in premenopausal women and potential consequences later in life. ClinicalTrials.gov identifier: NCT03213457.

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“…Four randomized controlled trials with 1949 participants were included in the study (27)(28)(29)(30). All four trials reported the primary outcome.…”

Section: Included Studiesmentioning

confidence: 99%

Elagolix Treatment in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroid: A Systematic Review and Meta-analysis

Yusof

Norhayati

Muhammad

et al. 2021

Preprint

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Background: Elagolix is effective and safe for treating menorrhagia in women with uterine fibroid. However, it is reported to be associated with hypoestrogenism that can be alleviated by adding estradiol/norethindrone acetate. This systematic review and meta-analysis aimed to determine the effectiveness of elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroid by comparing: elagolix versus placebo and elagolix versus estradiol/norethindrone acetate.Methodology: The Cochrane Central Register of Controlled Trials (CENTRAL 2021, Issue 3 of 12), MEDLINE databases (1980 to December week 1, 2020), and trial registries for relevant randomized clinical trials were used. All randomized clinical trials were reviewed and evaluated. Random effects models were used to estimate the dichotomous outcomes and mean differences with 95% confidence intervals. Data for risk of bias, heterogeneity, sensitivity, reporting bias and quality of evidence were assessed. Results: Four randomized controlled trials with 1949 premenopausal women from 323 locations were included. Elagolix improved menstrual blood loss of less than 80 ml (RR 4.81, 95% CI 2.45 to 9.45; four trials, 869 participants; moderate quality evidence) or more than 50% reduction from baseline (RR 4.87, 95% CI 2.55 to 9.31; four trials, 869 participants; moderate quality evidence) compared to placebo. There was no difference in menstrual blood loss of less than 80 ml (RR 1.08, 95% CI 1.00 to 1.16; five trials, 1365 participants; moderate quality evidence) or more than 50% reduction from baseline between the elagolix (RR 1.08, 95% CI 1.01 to 1.15; five trials, 1365 participants; high quality evidence) and elagolix with estradiol/norethindrone acetate. In both comparisons, elagolix has reduced the mean percentage change in uterine and fibroid volume, improved symptoms, and health-related quality of life. More patients had hot flush, and bone mineral density loss in the elagolix treatment compared to both placebo and elagolix with estradiol/norethindrone acetate.Conclusions: Elagolix appeared to be effective in reducing heavy menstrual bleeding caused by uterine fibroid and combination with estradiol/norethindrone acetate was able to alleviate the hypoestrogenism side effects in premenopausal women.Review registration. PROSPERO CDR 42021233898.

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Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas

Cited by 8 publications

References 0 publications

2021 Update on abnormal uterine bleeding

2021 Update on abnormal uterine bleeding

Bone Mineral Density Changes Associated With Pregnancy, Lactation, and Medical Treatments in Premenopausal Women and Effects Later in Life

Elagolix Treatment in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroid: A Systematic Review and Meta-analysis

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