title: Bazedoxifene when paired with conjugated estrogens is a new paradigm for treatment of postmenopausal women.
abstract: BACKGROUND
  The concept of the tissue selective estrogen complex (TSEC) combining a selective estrogen receptor modulator (SERM) with one or more estrogens, aims to provide comparable efficacy to combination estrogen and progestin therapy for symptomatic menopausal women with a uterus without the need for a progestin.
  
  
  METHODS
  Published multi-center randomized blinded clinical trials with bazedoxifene alone and paired in combination with conjugated estrogens show an effect in hot flashes, vaginal atrophy, quality of life measures, sleep, bone density, and breast and uterine safety.
  
  
  RESULTS
  A new concept for menopausal women, bazedoxifene with conjugated estrogens (BZA-CE) TSEC, appears to provide the selective benefits of a SERM with additional benefits of estrogen without the need for a progestin. Preclinical studies with bazedoxifene alone showed that it was antagonistic in the uterine and breast tissue while an agonist in the bone. Phase II and III clinical studies of BZA-CE reveal relief from hot flashes and vaginal atrophic changes, and improvement in bone density, quality of life and sleep without breast or uterine stimulation.
  
  
  CONCLUSIONS
  Bazedoxifene paired with conjugated estrogens in postmenopausal women relieves vasomotor symptoms and vulvovaginal atrophic changes with prevention of bone loss. Adverse events include a twofold increase risk of venous thrombosis. No evidence of stimulation of the breast, uterus or ovary was seen.
authors.affiliation: University of Virginia Health System, Division of Midlife, Department of Obstetrics and Gynecology, Box 801104, Charlottesville, VA 22908, USA. jvp9u@virginia.edu
authors.forename: Joann V
authors.initials: JV
authors.lastname: Pinkerton
authors.forename: Dale W
authors.initials: DW
authors.lastname: Stovall
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000379:methods; D004359:Drug Therapy, Combination; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy / Q000378:metabolism; D006801:Humans; D007211:Indoles / Q000008:administration & dosage*; D015663:Osteoporosis, Postmenopausal / Q000378:metabolism / Q000517:prevention & control; D017698:Postmenopause / Q000187:drug effects* / Q000378:metabolism; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D004966:Estrogens, Conjugated (USP); D007211:Indoles; D020845:Selective Estrogen Receptor Modulators; C447119:bazedoxifene