Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist
| Autor: | Mauricio Simões Abrão, Kristof Chwalisz, Jacqueline Thomas, David F. Archer, Michael P. Diamond, Hugh S. Taylor, Eric S. Surrey, W.R. Duan, Bruce R. Carr, Juki Ng, Rita Jain, Bruce A. Lessey, J. Kotarski, Nicholas Leyland, Nelson B. Watts, Linda C. Giudice, James A. Simon, J.P. Rowan, B. Schwefel, J. C. Gallagher, Neil P. Johnson, W. P. Dmowski |
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| Rok vydání: | 2018 |
| Předmět: |
Hydrocarbons
Fluorinated Endometriosis Reproductive health and childbirth Medical and Health Sciences Gastroenterology law.invention Gonadotropin-Releasing Hormone 0302 clinical medicine Randomized controlled trial Fluorinated law Bone Density Medicine Young adult 030219 obstetrics & reproductive medicine Pain Research GnRH Antagonist Estrogen Antagonists General Medicine Middle Aged Lipids 030220 oncology & carcinogenesis 6.1 Pharmaceuticals Female Drug Chronic Pain medicine.symptom Adult medicine.medical_specialty Adolescent medicine.drug_class Clinical Trials and Supportive Activities Pelvic Pain Placebo Dose-Response Relationship 03 medical and health sciences Young Adult Double-Blind Method Dysmenorrhea Clinical Research General & Internal Medicine Internal medicine Complementary and Integrative Health Humans Dose-Response Relationship Drug business.industry Contraception/Reproduction Pelvic pain Antagonist Evaluation of treatments and therapeutic interventions medicine.disease Hydrocarbons Surgery Clinical trial Pyrimidines Premenopause Estrogen Hot Flashes Once daily business Hormone |
| Zdroj: | The New England journal of medicine, vol 377, iss 1 Taylor, HS; Giudice, LC; Lessey, BA; Abrao, MS; Kotarski, J; Archer, DF; et al.(2017). Treatment of endometriosis-associated pain with elagolix, an oral GnRH antagonist. New England Journal of Medicine, 377(1), 28-40. doi: 10.1056/NEJMoa1700089. UCSF: Retrieved from: http://www.escholarship.org/uc/item/3pw94370 |
| ISSN: | 1662-4009 |
| DOI: | 10.1530/ey.15.15.6 |
| Popis: | Endometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain. Elagolix, an oral, nonpeptide, gonadotropin-releasing hormone (GnRH) antagonist, produced partial to nearly full estrogen suppression in previous studies.We performed two similar, double-blind, randomized, 6-month phase 3 trials (Elaris Endometriosis I and II [EM-I and EM-II]) to evaluate the effects of two doses of elagolix - 150 mg once daily (lower-dose group) and 200 mg twice daily (higher-dose group) - as compared with placebo in women with surgically diagnosed endometriosis and moderate or severe endometriosis-associated pain. The two primary efficacy end points were the proportion of women who had a clinical response with respect to dysmenorrhea and the proportion who had a clinical response with respect to nonmenstrual pelvic pain at 3 months. Each of these end points was measured as a clinically meaningful reduction in the pain score and a decreased or stable use of rescue analgesic agents, as recorded in a daily electronic diary.A total of 872 women underwent randomization in Elaris EM-I and 817 in Elaris EM-II; of these women, 653 (74.9%) and 632 (77.4%), respectively, completed the intervention. At 3 months, a significantly greater proportion of women who received each elagolix dose met the clinical response criteria for the two primary end points than did those who received placebo. In Elaris EM-I, the percentage of women who had a clinical response with respect to dysmenorrhea was 46.4% in the lower-dose elagolix group and 75.8% in the higher-dose elagolix group, as compared with 19.6% in the placebo group; in Elaris EM-II, the corresponding percentages were 43.4% and 72.4%, as compared with 22.7% (P |
| Databáze: | OpenAIRE |
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