Display Settings:

Format

Send to:

Choose Destination
  • PMID: 23250083 was deleted because it is a duplicate of PMID: 23266839
See comment in PubMed Commons below
Menopause. 2013 Jan;20(1):38-46. doi: 10.1097/GME.0b013e318274699f.

Maintenance of the efficacy of desvenlafaxine in menopausal vasomotor symptoms: a 1-year randomized controlled trial.

Author information

  • 1University of Virginia Health System, Charlottesville 22903, USA. JVP9U@Virginia.edu

Abstract

OBJECTIVE:

The purpose of this study was to assess the 1-year maintenance of the efficacy of desvenlafaxine 100 mg/day (administered as desvenlafaxine succinate) established on week 12 in a 1-year, double-blind, randomized, placebo-controlled trial in postmenopausal women seeking treatment of bothersome vasomotor symptoms.

METHODS:

Primary efficacy endpoints were changes in hot flush (HF) frequency and severity on weeks 12, 26, and 52 in an efficacy substudy population (≥50 moderate and severe HFs per week at baseline). Secondary endpoints were Greene climacteric scale, patient global impression symptom rating, and patient global impression of change scores (weeks 12, 26, and 52) for the main study efficacy population. Safety was assessed throughout the trial.

RESULTS:

The mean baseline HF frequency (efficacy substudy population, n = 365) was 12 moderate and severe HFs per day; the mean baseline severity score was 2.4. At 1 year, women treated with desvenlafaxine maintained the efficacy established on week 12. Desvenlafaxine reduced HF frequency by 7.47 moderate and severe HFs per day on week 12 (adjusted mean difference from placebo, -2.48; 95% CI, -3.47 to -1.50; P < 0.001) and by 7.70 moderate and severe HFs per day on month 12 (adjusted mean difference from placebo, -2.86; 95% CI, -4.14 to -1.57; P < 0.001). Desvenlafaxine reduced the mean severity score by 0.63 on week 12 (placebo, -0.30; P < 0.001) and by 0.75 on month 12 (placebo, -0.44; P = 0.003). Reductions in Greene Climacteric Scale total score (main study efficacy population, n = 1,950) were significantly greater for desvenlafaxine than for placebo on months 3, 6, and 12 (all P < 0.001). Treatment-emergent adverse event rates were 84% for desvenlafaxine and 79% for placebo (P = 0.006). Full safety results are reported separately.

CONCLUSIONS:

The treatment efficacy of desvenlafaxine 100 mg/day achieved on week 12 in postmenopausal women with vasomotor symptoms is maintained for 1 year.

PMID:
23266839
[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Loading ...
    Write to the Help Desk