title: A double-blind, randomly assigned, placebo-controlled study of desvenlafaxine efficacy and safety for the treatment of vasomotor symptoms associated with menopause.
abstract: OBJECTIVE
  The objective of the study was to assess the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) for menopausal vasomotor symptoms.
  
  
  METHODS
  Postmenopausal women (n = 458) experiencing 50 or more moderate to severe hot flushes per week received desvenlafaxine 100 or 150 mg/d, with titration at therapy initiation, or placebo. Hot flush number and severity were assessed at weeks 4 and 12. Safety data were collected throughout the trial.
  
  
  RESULTS
  Desvenlafaxine 100 and 150 mg/d significantly reduced the number of hot flushes compared with placebo at weeks 4 and 12 (all P < or = .012), achieving 65.4% and 66.6% reductions from baseline at week 12, respectively (placebo, 50.8%). Hot flush severity and number of nighttime awakenings were significantly reduced at both time points (all P < or = .048). Desvenlafaxine groups reported significantly more adverse events compared with placebo during week 1 only. No difference in discontinuations because of adverse events was observed.
  
  
  CONCLUSIONS
  Desvenlafaxine is an effective nonhormonal treatment for menopausal hot flushes. Dose titration improves initial tolerability.
authors.affiliation: Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA 23507, USA. archerdf@evms.edu
authors.forename: David F
authors.initials: DF
authors.lastname: Archer
authors.forename: Larry
authors.initials: L
authors.lastname: Seidman
authors.forename: Ginger D
authors.initials: GD
authors.lastname: Constantine
authors.forename: James H
authors.initials: JH
authors.lastname: Pickar
authors.forename: Sophie
authors.initials: S
authors.lastname: Olivier
mesh_terms: D000328:Adult; D000368:Aged; D003511:Cyclohexanols / Q000494:pharmacology / Q000627:therapeutic use*; D000069468:Desvenlafaxine Succinate; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D014179:Neurotransmitter Uptake Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D017698:Postmenopause; D016896:Treatment Outcome; D014481:United States; D014666:Vasomotor System / Q000187:drug effects
chemical_list: D003511:Cyclohexanols; D014179:Neurotransmitter Uptake Inhibitors; D000069468:Desvenlafaxine Succinate