A double-blind, randomly assigned, placebo-controlled study of desvenlafaxine efficacy and safety for the treatment of vasomotor symptoms associated with menopause - 12/08/11
, Larry Seidman, DO b, Ginger D. Constantine, MD c, James H. Pickar, MD c, Sophie Olivier, MD c
Reprints: David F. Archer, MD, The Jones Institute for Reproductive Medicine, 601 Colley Ave., Norfolk, VA 23507Résumé |
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 ≤ .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 ≤ .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.
Le texte complet de cet article est disponible en PDF.Key words : desvenlafaxine succinate, hot flushes, menopause, nonhormonal treatment, vasomotor symptoms
Plan
| Cite this article as: Archer DF, Seidman L, Constantine GD, et al. 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;200:172.e1-172.e10. |
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| This study was supported in part by Wyeth Research. Dr Archer is a consultant for Wyeth Research and has received grants and honoraria from the Wyeth Speakers Bureau. Dr Seidman is a consultant for Wyeth Research, Duramed Pharmaceuticals, Inc, and Bayer Pharmaceuticals Corp. Drs Constantine, Pickar, and Olivier are employees of Wyeth Research. |
Vol 200 - N° 2
P. 172.e1-172.e10 - février 2009 Retour au numéro
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