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https://read.qxmd.com/read/30774352/uterine-fibroids-an-update-on-current-and-emerging-medical-treatment-options
#1
REVIEW
Manuela Farris, Carlo Bastianelli, Elena Rosato, Ivo Brosens, Giuseppe Benagiano
Uterine fibroids are the most common gynecological disorder, classically requiring surgery when symptomatic. Although attempts at finding a nonsurgical cure date back to centuries, it is only around the middle of the last century that serious attempts at a medical treatment were carried out. Initially, both progestins and estrogen-progestin combinations have been utilized, although proof of their usefulness is lacking. A major step forward was achieved when peptide analogs of the GnRH were introduced, first those with superagonist properties and subsequently those acting as antagonists...
2019: Therapeutics and Clinical Risk Management
https://read.qxmd.com/read/30763525/a-comprehensive-review-of-hormonal-and-biological-therapies-for-endometriosis-latest-developments
#2
Fabio Barra, Giovanni Grandi, Matteo Tantari, Carolina Scala, Fabio Facchinetti, Simone Ferrero
Endometriosis is a chronic benign estrogen dependent disease characterized by the presence of endometriotic glands and stroma outside the uterine cavity. Although combined hormonal contraceptives and progestins, currently available first-line treatments for endometriosis, are efficacious and well tolerated for treating disease-related pain, some women experience partial or no improvement of pain or its recurrence is frequent after discontinuation of the therapies. For these reasons, new drugs are under investigation for the treatment of endometriosis...
February 14, 2019: Expert Opinion on Biological Therapy
https://read.qxmd.com/read/30724096/cost-effectiveness-of-elagolix-versus-leuprolide-acetate-for-treating-moderate-to-severe-endometriosis-pain-in-the-usa
#3
Si-Tien Wang, Scott J Johnson, Dominic Mitchell, Ahmed M Soliman, Jamie B Vora, Sanjay K Agarwal
AIM: To assess the cost-effectiveness of elagolix versus leuprolide acetate in women with moderate to severe endometriosis pain. METHODS: A Markov model was developed. The efficacy of leuprolide acetate was derived from statistical prediction models using elagolix trial data. Model inputs were extracted from Phase III clinical trials and published literature. RESULTS: Compared with leuprolide acetate, elagolix generated positive net monetary benefit (NMB) assuming a payer's willingness-to-pay threshold of US$100,000 per quality-adjusted life year over a 1-year time horizon: US$5660 for elagolix 150 mg and US$6443 for elagolix 200 mg...
February 6, 2019: Journal of Comparative Effectiveness Research
https://read.qxmd.com/read/30570832/elagolix-pharmacokinetic-profiles-in-women-with-renal-or-hepatic-impairment
#4
Juki Ng, W Rachel Duan, Thomas Marbury, Jeffrey M Schmidt, Cheri E Klein
The aim of these studies was to assess the safety and pharmacokinetics of elagolix, an oral nonpeptide gonadotropin-releasing hormone antagonist following oral administration in women with renal or hepatic impairment. Two phase 1 studies were conducted in adult women with normal renal function versus renal impairment (reduced study), and normal hepatic function versus hepatic impairment (full study design). All women received a single dose of elagolix 200 mg (renal) or 150 mg (hepatic). Intensive pharmacokinetic blood samples were collected...
December 20, 2018: Clinical Pharmacology in Drug Development
https://read.qxmd.com/read/30551159/elagolix-for-endometriosis-all-that-glitters-is-not-gold
#5
Paolo Vercellini, Paola Viganò, Giussy Barbara, Laura Buggio, Edgardo Somigliana
Elagolix, an orally active non-peptidic GnRH antagonist, has been approved by the Food and Drug Administration for the management of moderate to severe pain associated with endometriosis. As the degree of ovarian suppression obtained with elagolix is dose-dependent, pain relief may be achieved by modulating the level of hypo-oestrogenism while limiting side effects. Elagolix may thus be considered a novelty in terms of its endocrine and pharmacological properties but not for its impact on the pathogenic mechanisms of endometriosis, as the target of this new drug is, yet again, alteration of the hormonal milieu...
February 1, 2019: Human Reproduction
https://read.qxmd.com/read/30461685/long-term-outcomes-of-elagolix-in-women-with-endometriosis-results-from-two-extension-studies-correction
#6
(no author information available yet)
No abstract text is available yet for this article.
December 2018: Obstetrics and Gynecology
https://read.qxmd.com/read/30430369/correction-to-elagolix-first-global-approval
#7
Yvette N Lamb
The original article can be found online.
November 15, 2018: Drugs
https://read.qxmd.com/read/30415802/baricitinib-tildrakizumab-asmn-and-elagolix-sodium
#8
Daniel A Hussar, Julia E Kaminski
No abstract text is available yet for this article.
November 2018: Journal of the American Pharmacists Association: JAPhA
https://read.qxmd.com/read/30383729/elagolix-orilissa-an-oral-gnrh-antagonist-for-endometriosis-pain
#9
REVIEW
(no author information available yet)
No abstract text is available yet for this article.
September 24, 2018: Medical Letter on Drugs and Therapeutics
https://read.qxmd.com/read/30303923/elagolix-alone-or-with-add-back-therapy-in-women-with-heavy-menstrual-bleeding-and-uterine-leiomyomas-a-randomized-controlled-trial
#10
Bruce R Carr, Elizabeth A Stewart, David F Archer, Ayman Al-Hendy, Linda Bradley, Nelson B Watts, Michael P Diamond, Jingjing Gao, Charlotte D Owens, Kristof Chwalisz, W Rachel Duan, Ahmed M Soliman, Matthew B Dufek, James A Simon
OBJECTIVE: To evaluate elagolix, an oral gonadotropin-releasing hormone receptor antagonist, alone or with add-back therapy, in premenopausal women with heavy menstrual bleeding (greater than 80 mL per month) associated with uterine leiomyomas. METHODS: This double-blind, randomized, placebo-controlled, parallel-group study evaluated efficacy and safety of elagolix in cohorts 1 (300 mg twice daily) and 2 (600 mg daily) with four arms per cohort: placebo, elagolix alone, elagolix with 0...
November 2018: Obstetrics and Gynecology
https://read.qxmd.com/read/30271102/pharmaceutical-approval-update
#11
Mary Choy
Ivosidenib (Tibsovo) for acute myeloid leukemia; elagolix (Orilissa) for endometriosis; and mogamulizumab-kpkc (Poteligeo) for mycosis fungoides or Sézary syndrome.
October 2018: P & T: a Peer-reviewed Journal for Formulary Management
https://read.qxmd.com/read/30194661/elagolix-first-global-approval
#12
Yvette N Lamb
Elagolix (ORILISSA™), an orally bioavailable, second-generation, non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist, is being developed AbbVie and Neurocrine Biosciences for the treatment of reproductive hormone-dependent disorders in women. In July 2018, the US FDA approved elagolix tablets for the management of moderate to severe pain associated with endometriosis. This approval was based on positive results in two replicate phase III trials; additional phase III trials in the USA, Canada and Puerto Rico are currently evaluating elagolix as both monotherapy and in combination with low-dose hormone add-back therapy in the same indication...
September 2018: Drugs
https://read.qxmd.com/read/29946962/current-and-emerging-therapeutics-for-the-management-of-endometriosis
#13
REVIEW
Simone Ferrero, Fabio Barra, Umberto Leone Roberti Maggiore
Endometriosis is a chronic benign disease that affects women of reproductive age. Medical therapy is often the first line of management for women with endometriosis in order to ameliorate symptoms or to prevent post-surgical disease recurrence. Currently, there are several medical options for the management of patients with endometriosis. Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used in the treatment of chronic inflammatory conditions, being efficacious in relieving primary dysmenorrhea. Combined oral contraceptives (COCs) and progestins, available for multiple routes of administration, are effective first-line hormonal options...
July 2018: Drugs
https://read.qxmd.com/read/29921430/use-of-elagolix-in-gynaecology
#14
Hugh S Taylor
No abstract text is available yet for this article.
July 2018: Journal of Obstetrics and Gynaecology Canada: JOGC
https://read.qxmd.com/read/29889764/long-term-outcomes-of-elagolix-in-women-with-endometriosis-results-from-two-extension-studies
#15
Eric Surrey, Hugh S Taylor, Linda Giudice, Bruce A Lessey, Mauricio S Abrao, David F Archer, Michael P Diamond, Neil P Johnson, Nelson B Watts, J Chris Gallagher, James A Simon, Bruce R Carr, W Paul Dmowski, Nicholas Leyland, Sukhbir S Singh, Tomasz Rechberger, Sanjay K Agarwal, W Rachel Duan, Brittany Schwefel, James W Thomas, Paul M Peloso, Juki Ng, Ahmed M Soliman, Kristof Chwalisz
OBJECTIVE: To evaluate the efficacy and safety of elagolix, an oral, nonpeptide gonadotropin-releasing hormone antagonist, over 12 months in women with endometriosis-associated pain. METHODS: Elaris Endometriosis (EM)-III and -IV were extension studies that evaluated an additional 6 months of treatment after two 6-month, double-blind, placebo-controlled phase 3 trials (12 continuous treatment months) with two elagolix doses (150 mg once daily and 200 mg twice daily)...
July 2018: Obstetrics and Gynecology
https://read.qxmd.com/read/29530558/-new-medical-treatments-for-painful-endometriosis-cngof-has-endometriosis-guidelines
#16
REVIEW
G Legendre, L Delbos, E Hudon, N Chabbert-Buffet, S Geoffron, M Sauvan, H Fernandez, P-E Bouet, P Descamps
OBJECTIVE: The objective of this work is to evaluate the place of new treatments in the management of endometriosis outside the context of infertility. METHODS: A review of the literature was conducted by consulting Medline data until July 2017. RESULTS: Dienogest is effective compared to placebo in short term (NP2) and long term (NP4) for the treatment of painful endometriosis. In comparison with GnRH agonists, dienogest is also effective in terms of decreased pain and improved quality of life in non-operated patients (NP2) as well as for recurrence of lesions and symptomatology postoperatively (NP2)...
March 2018: Gynecologie, Obstetrique, Fertilite & Senologie
https://read.qxmd.com/read/29476499/population-pharmacokinetics-of-elagolix-in-healthy-women-and-women-with-endometriosis
#17
Insa Winzenborg, Ahmed Nader, Akshanth R Polepally, Mohan Liu, Jacob Degner, Cheri E Klein, Nael M Mostafa, Peter Noertersheuser, Juki Ng
INTRODUCTION: Elagolix is a novel, orally active, non-peptide, competitive gonadotropin-releasing hormone (GnRH) receptor antagonist in development for the management of endometriosis with associated pain and heavy menstrual bleeding due to uterine fibroids. The pharmacokinetics of elagolix have been well-characterized in phase I studies; however, elagolix population pharmacokinetics have not been previously reported. Therefore, a robust model was developed to describe elagolix population pharmacokinetics and to evaluate factors affecting elagolix pharmacokinetic parameters...
October 2018: Clinical Pharmacokinetics
https://read.qxmd.com/read/29335207/synthesis-and-biological-evaluation-of-3-2-aminoethyl-uracil-derivatives-as-gonadotropin-releasing-hormone-gnrh-receptor-antagonists
#18
Seon-Mi Kim, Minhee Lee, So Young Lee, Soo-Min Lee, Eun Jeong Kim, Jae Sun Kim, Jihyae Ann, Jiyoun Lee, Jeewoo Lee
We investigated a series of uracil analogues by introducing various substituents on the phenyl ring of the N-3 aminoethyl side chain and evaluated their antagonistic activity against human gonadotropin-releasing hormone (GnRH) receptors. Analogues with substituents at the ortho or meta position demonstrated potent in vitro antagonistic activity. Specifically, the introduction of a 2-OMe group enhanced nuclear factor of activated T-cells (NFAT) inhibition up to 6-fold compared to the unsubstituted analogue...
February 10, 2018: European Journal of Medicinal Chemistry
https://read.qxmd.com/read/29245894/elagolix-a-promising-oral-gnrh-antagonist-for-endometriosis-associated-pain
#19
EDITORIAL
Erica C Dun, Hugh S Taylor
No abstract text is available yet for this article.
November 21, 2017: Oncotarget
https://read.qxmd.com/read/28737050/efficacy-of-elagolix-in-the-treatment-of-endometriosis
#20
REVIEW
Alexandra Perricos, René Wenzl
Much research has gone into developing medications that can be used to alleviate endometriosis-associated symptoms. In addition to already established medications, a new GnRH antagonist, elagolix, is in development. The novelty of this drug compared to other GnRH antagonists, is its nonpeptide structure, allowing it to be administered orally. Areas covered: We analyzed several Phase I, II and III clinical trials that have evaluated the safety and efficacy of this new medication. Expert opinion: Since many medications have been put on the market and have gained popularity for the treatment of endometriosis-associated symptoms, the demonstration of equality or superiority of effect, tolerability, as well as patient compliance should be assessed when introducing a new drug...
September 2017: Expert Opinion on Pharmacotherapy
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