Effects of elagolix: A Synthesis of Findings from 24 Studies

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Original Abstract of the Article

Main Research Findings

Elagolix is a new oral gonadotropin-releasing hormone (GnRH) antagonist that has been shown to be effective in treating endometriosis-associated pain. 4 、 2 、 8 、. Compared to traditional GnRH agonists, elagolix has several advantages, including faster onset of action, no initial flare-up of symptoms, and oral administration. 10 、 19 、 12 、. Elagolix works by binding to GnRH receptors, which reduces the production of hormones such as estrogen and progesterone. 6 、. This helps to reduce the growth and inflammation of endometriosis lesions, leading to pain relief. 22 、 7 .

Multiple clinical trials have confirmed that elagolix is effective in reducing pain associated with endometriosis. 4 、 2 、 24 、 14 、 6 . Moreover, studies have shown that elagolix causes less bone mineral density loss compared to other GnRH agonists. 3 、 14 、 13 .

Benefits and Risks

Benefit Summary

Elagolix is a new, effective, and orally-administered treatment for endometriosis-associated pain. Elagolix has shown to cause less bone mineral density loss than traditional GnRH agonists. Elagolix has also shown potential effectiveness in treating heavy menstrual bleeding due to uterine fibroids. 17 .

Risk Summary

The main side effects of elagolix are related to estrogen depletion. Estrogen depletion can lead to bone mineral density loss, hot flashes, vaginal dryness, mood swings, and other related issues. 4 . Elagolix may also affect liver function. Therefore, people with impaired liver function or liver disease should consult a doctor before taking elagolix. 19 .

Comparison Across Studies

Commonalities Across Studies

Multiple studies have shown that elagolix is effective in reducing pain associated with endometriosis. Studies also agree that elagolix causes less bone mineral density loss than other GnRH agonists.

Differences Across Studies

The dosage, duration of treatment, and patient demographics may differ across studies. Therefore, the results and side effects of elagolix may vary. The age and severity of symptoms of the participants may also vary, impacting the outcome of the study.

Consistency and Contradictions in Findings

The effectiveness of elagolix is consistent across multiple studies. However, there are inconsistencies in the research regarding the impact of elagolix on bone mineral density. The effect of elagolix on bone mineral density may depend on factors like dosage, treatment duration, patient age, and physical condition.

Points to Note for Real-World Applications

Although elagolix is effective in reducing pain associated with endometriosis, it can cause side effects related to estrogen depletion. Therefore, before taking elagolix, it is crucial to consult a doctor and understand the risks and benefits of the treatment. Also, as elagolix can decrease bone mineral density, people with osteoporosis prevention or treatment should consult a doctor before taking elagolix.

Current Research Limitations

Long-term effects and safety of elagolix remain largely unknown, requiring further research. Comparisons with other treatments to determine the superiority of elagolix are also needed. As elagolix is a new drug, sufficient data are still accumulating.

Future Research Directions

Further research is needed to determine the long-term effects and safety of elagolix. Research comparing the effectiveness of elagolix to other treatments is crucial. Studies are also needed to determine which patients are suitable candidates for elagolix treatment.

Conclusion

Elagolix is a new and effective treatment for endometriosis-associated pain. Compared to traditional GnRH agonists, elagolix offers advantages like no initial flare-up of symptoms and less bone mineral density loss. However, elagolix can cause side effects related to estrogen depletion. Therefore, consulting a doctor and understanding the risks and benefits of elagolix is important before taking it.

Literature analysis of 24 papers
Positive Content
22
Neutral Content
2
Negative Content
0
Article Type
4
1
2
9
24
1.

Oriahnn: New Drug Approved for Treating Heavy Menstrual Bleeding in Women With Uterine Fibroids.

Author: LynchSarah E, MayerDanielle C

Menstrual bleeding reduction
Uterine fibroid treatment
Headache
Hot flushes
Nausea
Night sweats

Elagolix plus add-back therapy was effective in reducing menstrual bleeding associated with uterine fibroids.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

2.

Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist.

Author: TaylorHugh S, GiudiceLinda C, LesseyBruce A, AbraoMauricio S, KotarskiJan, ArcherDavid F, DiamondMichael P, SurreyEric, JohnsonNeil P, WattsNelson B, GallagherJ Chris, SimonJames A, CarrBruce R, DmowskiW Paul, LeylandNicholas, RowanJean P, DuanW Rachel, NgJuki, SchwefelBrittany, ThomasJames W, JainRita I, ChwaliszKristof

Improved dysmenorrhea
Improved pelvic pain
Decreased bone mineral density
Hot flushes
Increased serum lipids

Elagolix, a gonadotropin-releasing hormone (GnRH) antagonist, was effective in improving dysmenorrhea and nonmenstrual pelvic pain in women with endometriosis-associated pain.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

3.

Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis.

Author: StodtmannSven, NaderAhmed, PolepallyAkshanth R, SuleimanAhmed A, WinzenborgInsa, NoertersheuserPeter, NgJuki, MostafaNael M, ShebleyMohamad

BMD preservation
Endometriosis pain management
Heavy menstrual bleeding management
BMD decrease

This study used a quantitative systems pharmacology (QSP) model to predict bone mineral density (BMD) changes in premenopausal women with endometriosis treated with elagolix. The QSP model successfully predicted BMD changes based on estradiol levels, validating the model for predicting the long-term impact of elagolix on BMD.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Validation StudyResearch to assess the validity and reliability of new measurement methods or diagnostic tests.

Language : English

4.

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

Author: LeylandNicholas, EstesStephanie J, LesseyBruce A, AdvinculaArnold P, TaylorHugh S

Endometriosis pain treatment
Improved quality of life

This review provides an overview of elagolix, highlighting currently available treatment options and the application of this new treatment for women with endometriosis-associated pain.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

Drug-Drug Interaction Studies of Elagolix with Oral and Transdermal Low-Dose Hormonal Add-Back Therapy.

Author: NaderAhmed, MostafaNael M, AliFarah, ShebleyMohamad

Reduced hypoestrogenic effects

Elagolix, a medication for endometriosis and uterine fibroids pain, might have pharmacokinetic interactions with low-dose hormonal add-back therapy, which is sometimes used to reduce elagolix's side effects. Further research is needed to determine the extent of this interaction.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Investigational drugs for the treatment of endometriosis, an update on recent developments.

Author: BarraFabio, ScalaCarolina, MaisValerio, GuerrieroStefano, FerreroSimone

Endometriosis treatment

Endometriosis is a chronic disease that can be challenging to treat effectively, with current medications sometimes providing only partial relief and symptoms often recurring after treatment stops. New drugs are being developed for this condition.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

Efficacy of elagolix in the treatment of endometriosis.

Author: PerricosAlexandra, WenzlRené

Bone loss

Elagolix is a new oral GnRH antagonist being developed for the treatment of endometriosis. This review analyzes clinical trials that evaluated the safety and efficacy of elagolix. The drug is well-tolerated and has a favorable side effect profile. Further studies are needed to determine whether elagolix can compete with or surpass established treatments for endometriosis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

10.

Suppression of gonadotropins and estradiol in premenopausal women by oral administration of the nonpeptide gonadotropin-releasing hormone antagonist elagolix.

Author: StruthersR Scott, NichollsAndrew J, GrundyJohn, ChenTakung, JimenezRoland, YenSamuel S C, BozigianHaig P

Estradiol suppression
Gonadotropin suppression
None specified

Oral administration of elagolix, a nonpeptide GnRH antagonist, suppressed the reproductive endocrine axis in healthy premenopausal women. These results suggest that elagolix may enable dose-related pituitary and gonadal suppression in premenopausal women as part of treatment strategies for reproductive hormone-dependent disease states.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

11.

Research advances in drug therapy of endometriosis.

Author: ShiJianyou, TanXin, FengGuimei, ZhuoYuan, JiangZhongliang, BandaSrikanth, WangLin, ZhengWei, ChenLu, YuDongke, GuoChun

Endometriosis treatment

This review provides an overview of the pathogenesis of endometriosis and discusses newly reported lead compounds and drugs used to manage the condition. The review explores potential therapeutic targets and the effectiveness of various drugs, highlighting the need for further research and development of more effective and safer treatments.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

12.

Advances in pharmacotherapy for treating endometriosis.

Author: TafiEmanuela, Leone Roberti MaggioreUmberto, AlessandriFranco, BoglioloStefano, GardellaBarbara, VelloneValerio Gaetano, GrilloFederica, MastracciLuca, FerreroSimone

Endometriosis treatment
Side effects

This review summarizes the currently available medical treatment for endometriosis and focuses on the most recently proposed treatments, including gonadotropin-releasing hormone (GnRH) antagonists, aromatase inhibitors (AIs) and the flexible extended combined oral contraceptive. While oral contraceptive pills and progestogens are effective for many patients, GnRH agonists, GnRH antagonists, and AIs are used for patients resistant to first-line therapy. These newer therapies are limited by their short-term use and high incidence of adverse effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

13.

Exposure-Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis-Associated Pain.

Author: Abbas SuleimanAhmed, NaderAhmed, WinzenborgInsa, BeckDenise, PolepallyAkshanth R, NgJuki, NoertersheuserPeter, MostafaNael M

BMD decrease

Elagolix, a gonadotropin-releasing hormone receptor antagonist, was studied for managing endometriosis pain. A model was developed to describe the relationship between elagolix exposure and bone mineral density (BMD) changes. The model predicts a 1.45% decrease in BMD with elagolix 150 mg daily for 24 months.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Elagolix, an oral GnRH antagonist, versus subcutaneous depot medroxyprogesterone acetate for the treatment of endometriosis: effects on bone mineral density.

Author: CarrBruce, DmowskiW Paul, O'BrienChris, JiangPing, BurkeJoshua, JimenezRoland, GarnerElizabeth, ChwaliszKristof

Endometriosis pain relief
Bone mineral density decrease

Elagolix, a medication for endometriosis-associated pain, had minimal impact on bone mineral density (BMD) and demonstrated similar efficacy to DMPA-SC. The most common side effects were headache, nausea, and nasopharyngitis. This suggests that elagolix is a potentially effective and safe option for managing endometriosis-associated pain.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids.

Author: BeckDenise, WinzenborgInsa, LiuMohan, DegnerJacob, MostafaNael M, NoertersheuserPeter, ShebleyMohamad

This study aims to refine a model for predicting elagolix's effects in women with uterine fibroids who are also receiving hormonal therapy. This will help optimize treatment strategies for these patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

16.

Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas: A Randomized Controlled Trial.

Author: CarrBruce R, StewartElizabeth A, ArcherDavid F, Al-HendyAyman, BradleyLinda, WattsNelson B, DiamondMichael P, GaoJingjing, OwensCharlotte D, ChwaliszKristof, DuanW Rachel, SolimanAhmed M, DufekMatthew B, SimonJames A

Menstrual blood loss reduction
Bone mineral density decrease

Elagolix with and without add-back significantly reduced menstrual blood loss in women with uterine leiomyomas. Add-back therapy reduced hypoestrogenic effects on bone mineral density.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

17.

Oral Gonadotropin-Releasing Hormone Antagonists for the Treatment of Uterine Leiomyomas.

Author: NeblettMichael F, StewartElizabeth A

Amenorrhea
Anemia improvement
Leiomyoma bleeding reduction
Leiomyoma pain reduction
Reduced hypogonadal side effects
Uterine volume reduction
Hypogonadal side effects

This overview reviews the efficacy and safety of oral gonadotropin-releasing hormone (GnRH) antagonists for the management of uterine leiomyomas. Oral GnRH antagonists provide rapid suppression of sex steroids and can reduce leiomyoma-associated heavy menstrual bleeding, pain, and anemia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

19.

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

Author: ShebleyMohamad, PolepallyAkshanth R, NaderAhmed, NgJuki W, WinzenborgInsa, KleinCheri E, NoertersheuserPeter, GibbsMegan A, MostafaNael M

Bone mineral density maintenance
Endometriosis pain relief
Hepatic impairment
OATP1B1 inhibitor interaction

Elagolix is an effective treatment for endometriosis pain, with a well-understood pharmacologic profile. This abstract describes the clinical pharmacology and pharmacokinetics of elagolix, showing its effectiveness and providing information on dosing regimens and interactions with other medications.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

20.

Current and Emerging Therapeutics for the Management of Endometriosis.

Author: FerreroSimone, BarraFabio, Leone Roberti MaggioreUmberto

Endometriosis management

Endometriosis is a chronic condition in women of reproductive age. This review examines the various medical treatment options available, including NSAIDs, hormonal therapies (COCs and progestins), and GnRH agonists. It also discusses newer options like elagolix, but highlights the need for more research to compare them to existing therapies.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

22.

A peek into the drug development scenario of endometriosis - A systematic review.

Author: GoenkaLuxitaa, GeorgeMelvin, SenMaitrayee

Cost of treatment
Short-term effect
Side-effects

This review summarized the current status and challenges of drug development for endometriosis, considering the limitations of existing medical therapies in terms of cost, side effects, and short-term symptom relief.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

23.

Overview of elagolix for the treatment of endometriosis.

Author: MelisGian Benedetto, NeriManuela, CordaValentina, MaluneMaria Elena, PirasBruno, PirarbaSilvia, GuerrieroStefano, OrrùMarisa, D'AlterioMaurizio Nicola, AngioniStefano, PaolettiAnna Maria

Rapid onset
Reversibility of action
Histamine-related adverse events
Hypersensitivity reactions

GnRH antagonists rapidly suppress sex steroid levels and are reversible, offering advantages over GnRH agonists. However, older peptide antagonists have side effects like histamine reactions and hypersensitivity.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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