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

作者: Hugh S. Taylor , Linda C. Giudice , Bruce A. Lessey , Mauricio S. Abrao , Jan Kotarski

DOI: 10.1056/NEJMOA1700089

关键词:

摘要: BackgroundEndometriosis 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. MethodsWe performed two similar, double-blind, randomized, 6-month phase 3 trials (Elaris Endometriosis I II [EM-I EM-II]) evaluate the effects of doses elagolix — 150 mg once daily (lower-dose group) 200 twice (higher-dose as compared with placebo women surgically diagnosed endometriosis moderate or severe endometriosis-associated The primary efficacy end points were proportion who had clinical response respect nonmenstrual pain at months. Each these was measured clinically meaningful reduction score decreased stable use rescue analgesi...

参考文章(33)
Linda C. Giudice, Endometriosis New England Journal of Medicine. ,vol. 362, pp. 2389- 2398 ,(2010) , 10.1056/NEJMCP1000274
SERDAR E. BULUN, SIJUN YANG, ZHOJUAN FANG, BILGIN GURATES, MITSUTOSHI TAMURA, SIBY SEBASTIAN, Estrogen Production and Metabolism in Endometriosis Annals of the New York Academy of Sciences. ,vol. 955, pp. 75- 85 ,(2002) , 10.1111/J.1749-6632.2002.TB02767.X
Nelson B. Watts, William D. Leslie, A. Joseph Foldes, Paul D. Miller, 2013 International Society for Clinical Densitometry Position Development Conference: Task Force on Normative Databases Journal of Clinical Densitometry. ,vol. 16, pp. 472- 481 ,(2013) , 10.1016/J.JOCD.2013.08.001
Hongling Du, Hugh S. Taylor, Contribution of Bone Marrow‐Derived Stem Cells to Endometrium and Endometriosis Stem Cells. ,vol. 25, pp. 2082- 2086 ,(2007) , 10.1634/STEMCELLS.2006-0828
Robert L. Barbieri, Hormone treatment of endometriosis: the estrogen threshold hypothesis. American Journal of Obstetrics and Gynecology. ,vol. 166, pp. 740- 745 ,(1992) , 10.1016/0002-9378(92)91706-G
David L. Olive, Gonadotropin-Releasing Hormone Agonists for Endometriosis The New England Journal of Medicine. ,vol. 359, pp. 1136- 1142 ,(2008) , 10.1056/NEJMCT0803719
Jan J. Brosens, Birgit Gellersen, The uterus under hormonal control – Cycling for life Molecular and Cellular Endocrinology. ,vol. 358, pp. 145- ,(2012) , 10.1016/J.MCE.2012.02.023
Terry A. Jacobson, Matthew K. Ito, Kevin C. Maki, Carl E. Orringer, Harold E. Bays, Peter H. Jones, James M. McKenney, Scott M. Grundy, Edward A. Gill, Robert A. Wild, Don P. Wilson, W. Virgil Brown, National Lipid Association recommendations for patient-centered management of dyslipidemia: Part 1 – executive summary Journal of Clinical Lipidology. ,vol. 8, pp. 473- 488 ,(2014) , 10.1016/J.JACL.2014.07.007
Richard O. Burney, Said Talbi, Amy E. Hamilton, Kim Chi Vo, Mette Nyegaard, Camran R. Nezhat, Bruce A. Lessey, Linda C. Giudice, Gene Expression Analysis of Endometrium Reveals Progesterone Resistance and Candidate Susceptibility Genes in Women with Endometriosis Endocrinology. ,vol. 148, pp. 3814- 3826 ,(2007) , 10.1210/EN.2006-1692