title: New pharmacological therapies for vasomotor symptom management: focus on bazedoxifene/conjugated estrogens and paroxetine mesylate.
abstract: OBJECTIVE
  To review 2 recently approved therapies for vasomotor symptoms (VMSs) of menopause.
  
  
  METHODS
  PubMed searches (June 2003 to May 2014) were conducted using the keywords paroxetine vasomotor and bazedoxifene vasomotor. References from relevant articles were reviewed for pertinent citations that were not identified in the PubMed search.
  
  
  METHODS
  Phase 3 clinical trials of recently approved hormonal and nonhormonal therapies for the treatment of VMSs of menopause were selected. Studies that evaluated the use of paroxetine mesylate or bazedoxifene (BZA)/conjugated estrogens (CEs) for VMSs were included.
  
  
  RESULTS
  Four studies for BZA/CEs were identified. One published report of low-dose paroxetine mesylate was identified that was a combined analysis of 2 phase 3 studies. Both agents significantly decrease the incidence of hot flushes compared with placebo and are approved for the treatment of moderate to severe VMSs associated with menopause. BZA/CEs is only approved for women with an intact uterus. In all circumstances, the use of BZA/CEs should be limited to the shortest duration possible. Paroxetine mesylate was not studied head-to-head against hormone therapy, but the magnitude of its effect on VMSs is less than expected with hormone therapy.
  
  
  CONCLUSIONS
  BZA/CEs is an effective hormonal therapy for treating VMSs in women with an intact uterus. Paroxetine mesylate is the first nonhormonal therapy that the FDA has approved for VMSs, making both viable options for the treatment of VMSs of menopause.
authors.affiliation: University of Florida, Gainesville, FL, USA carris@ufl.edu.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Carris
authors.affiliation: Sarasota Memorial Hospital, Sarasota, FL, USA.
authors.forename: Sara
authors.initials: S
authors.lastname: Kutner
authors.affiliation: CVS, Jacksonville, FL, USA.
authors.forename: Shane
authors.initials: S
authors.lastname: Reilly-Rogers
mesh_terms: D002986:Clinical Trials as Topic; D004338:Drug Combinations; D004966:Estrogens, Conjugated (USP) / Q000627:therapeutic use*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008593:Menopause; D008698:Mesylates / Q000627:therapeutic use*; D017374:Paroxetine / Q000627:therapeutic use*; D014666:Vasomotor System / Q000187:drug effects* / Q000503:physiopathology
chemical_list: D004338:Drug Combinations; D004966:Estrogens, Conjugated (USP); D007211:Indoles; D008698:Mesylates; D017374:Paroxetine; C447119:bazedoxifene
keywords: ambulatory care; drug development and approval; hormonal replacement therapy; obstetrics/gynecology; women’s health