Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids.

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  • Additional Information
    • Affiliation:
      Thomas Jefferson University, Philadelphia
      Comprehensive Clinical Trials, West Palm Beach, FL, Illinois
      University of Illinois at Chicago, Illinois
      Eastern Virginia Medical School, Norfolk, Houston
      University of Pennsylvania, Philadelphia
      Cleveland Clinic, Cleveland, Houston
      University of Texas Southwestern Medical Center, Dallas, Houston
      Northwestern University, Illinois
      University of Texas Health Science Center at Houston, Houston
      Columbia University, New York
      Chicago, AbbVie, North Chicago, Illinois
      Advances in Health, Houston
      InVia Fertility, Hoffman Estates, Illinois
      Wayne State University, Detroit
      Torre de Auxilio Mutuo, San Juan, Puerto Rico
      George Washington University, Washington, DC
      Mayo Clinic and Mayo Clinic Alix School of Medicine, Rochester, MN
      Mercy Health, Cincinnati
    • Subject Terms:
    • Subject Terms:
    • Abstract:
      Background: Uterine fibroids are hormone-responsive neoplasms that are associated with heavy menstrual bleeding. Elagolix, an oral gonadotropin-releasing hormone antagonist resulting in rapid, reversible suppression of ovarian sex hormones, may reduce fibroid-associated bleeding.Methods: We conducted two identical, double-blind, randomized, placebo-controlled, 6-month phase 3 trials (Elaris Uterine Fibroids 1 and 2 [UF-1 and UF-2]) to evaluate the efficacy and safety of elagolix at a dose of 300 mg twice daily with hormonal "add-back" therapy (to replace reduced levels of endogenous hormones; in this case, estradiol, 1 mg, and norethindrone acetate, 0.5 mg, once daily) in women with fibroid-associated bleeding. An elagolix-alone group was included to assess the impact of add-back therapy on the hypoestrogenic effects of elagolix. The primary end point was menstrual blood loss of less than 80 ml during the final month of treatment and at least a 50% reduction in menstrual blood loss from baseline to the final month; missing data were imputed with the use of multiple imputation.Results: A total of 412 women in UF-1 and 378 women in UF-2 underwent randomization, received elagolix or placebo, and were included in the analyses. Criteria for the primary end point were met in 68.5% of 206 women in UF-1 and in 76.5% of 189 women in UF-2 who received elagolix plus add-back therapy, as compared with 8.7% of 102 women and 10% of 94 women, respectively, who received placebo (P<0.001 for both trials). Among the women who received elagolix alone, the primary end point was met in 84.1% of 104 women in UF-1 and in 77% of 95 women in UF-2. Hot flushes (in both trials) and metrorrhagia (in UF-1) occurred significantly more commonly with elagolix plus add-back therapy than with placebo. Hypoestrogenic effects of elagolix, especially decreases in bone mineral density, were attenuated with add-back therapy.Conclusions: Elagolix with add-back therapy was effective in reducing heavy menstrual bleeding in women with uterine fibroids. (Funded by AbbVie; Elaris UF-1 and Elaris UF-2 ClinicalTrials.gov numbers, NCT02654054 and NCT02691494.).
    • Journal Subset:
      Biomedical; Blind Peer Reviewed; Editorial Board Reviewed; Expert Peer Reviewed; Peer Reviewed; USA
    • Instrumentation:
      Bleeding Index
      Impact of Events Scale (IES)
    • ISSN:
      0028-4793
    • MEDLINE Info:
      PMID: NLM31971678 NLM UID: 0255562
    • Publication Date:
      20200131
    • Publication Date:
      20200523
    • DOI:
      http://dx.doi.org/10.1056/NEJMoa1904351
    • Accession Number:
      141444743
  • Citations
    • ABNT:
      SCHLAFF, W. D. et al. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids. New England Journal of Medicine, [s. l.], v. 382, n. 4, p. 328–340, 2020. DOI 10.1056/NEJMoa1904351. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=141444743. Acesso em: 20 set. 2020.
    • AMA:
      Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids. New England Journal of Medicine. 2020;382(4):328-340. doi:10.1056/NEJMoa1904351
    • APA:
      Schlaff, W. D., Ackerman, R. T., Al-Hendy, A., Archer, D. F., Barnhart, K. T., Bradley, L. D., Carr, B. R., Feinberg, E. C., Hurtado, S. M., JinHee Kim, Ran Liu, Mabey Jr., R. G., Owens, C. D., Poindexter, A., Puscheck, E. E., Rodriguez-Ginorio, H., Simon, J. A., Soliman, A. M., Stewart, E. A., & Watts, N. B. (2020). Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids. New England Journal of Medicine, 382(4), 328–340. https://doi.org/10.1056/NEJMoa1904351
    • Chicago/Turabian: Author-Date:
      Schlaff, William D., Ronald T. Ackerman, Ayman Al-Hendy, David F. Archer, Kurt T. Barnhart, Linda D. Bradley, Bruce R. Carr, et al. 2020. “Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids.” New England Journal of Medicine 382 (4): 328–40. doi:10.1056/NEJMoa1904351.
    • Harvard:
      Schlaff, W. D. et al. (2020) ‘Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids’, New England Journal of Medicine, 382(4), pp. 328–340. doi: 10.1056/NEJMoa1904351.
    • Harvard: Australian:
      Schlaff, WD, Ackerman, RT, Al-Hendy, A, Archer, DF, Barnhart, KT, Bradley, LD, Carr, BR, Feinberg, EC, Hurtado, SM, JinHee Kim, Ran Liu, Mabey Jr., RG, Owens, CD, Poindexter, A, Puscheck, EE, Rodriguez-Ginorio, H, Simon, JA, Soliman, AM, Stewart, EA & Watts, NB 2020, ‘Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids’, New England Journal of Medicine, vol. 382, no. 4, pp. 328–340, viewed 20 September 2020, .
    • MLA:
      Schlaff, William D., et al. “Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids.” New England Journal of Medicine, vol. 382, no. 4, Jan. 2020, pp. 328–340. EBSCOhost, doi:10.1056/NEJMoa1904351.
    • Chicago/Turabian: Humanities:
      Schlaff, William D., Ronald T. Ackerman, Ayman Al-Hendy, David F. Archer, Kurt T. Barnhart, Linda D. Bradley, Bruce R. Carr, et al. “Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids.” New England Journal of Medicine 382, no. 4 (January 23, 2020): 328–40. doi:10.1056/NEJMoa1904351.
    • Vancouver/ICMJE:
      Schlaff WD, Ackerman RT, Al-Hendy A, Archer DF, Barnhart KT, Bradley LD, et al. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids. New England Journal of Medicine [Internet]. 2020 Jan 23 [cited 2020 Sep 20];382(4):328–40. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=141444743