A double-blind, randomly assigned, placebo-controlled study of desvenlafaxine efficacy and safety for the treatment of vasomotor symptoms associated with menopause

Am J Obstet Gynecol. 2009 Feb;200(2):172.e1-10. doi: 10.1016/j.ajog.2008.09.877. Epub 2008 Dec 25.

Abstract

Objective: The objective of the study was to assess the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) for menopausal vasomotor symptoms.

Study design: 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.

Conclusion: Desvenlafaxine is an effective nonhormonal treatment for menopausal hot flushes. Dose titration improves initial tolerability.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Cyclohexanols / pharmacology
  • Cyclohexanols / therapeutic use*
  • Desvenlafaxine Succinate
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Hot Flashes / drug therapy*
  • Humans
  • Middle Aged
  • Neurotransmitter Uptake Inhibitors / pharmacology
  • Neurotransmitter Uptake Inhibitors / therapeutic use*
  • Postmenopause
  • Treatment Outcome
  • United States
  • Vasomotor System / drug effects

Substances

  • Cyclohexanols
  • Neurotransmitter Uptake Inhibitors
  • Desvenlafaxine Succinate