Desvenlafaxine succinate (DVS), a novel serotonin and norepinephrine reuptake inhibitor, improves mood and menopausal symptoms in women with hot flushes (HFs) associated with menopause

Abstract

To determine whether DVS, an effective non-hormonal treatment for HFs and night sweats, improves mood disturbances and other menopausal symptoms in a placebo-controlled trial of menopausal women with moderate-to-severe vasomotor symptoms (VMS). Twelve-week multicenter, randomized, double-blind, placebo-controlled trial with dose titration. Postmenopausal women with ≥50 moderate-to-severe HFs/week were randomly assigned to placebo or DVS 100 or 150 mg. Mood and climacteric symptoms were assessed by the Profile of Mood States (POMS) and the Greene Climacteric Scale (GCS), respectively, completed at baseline (BL) and weeks 4 and 12. Responses were analyzed using analysis of covariance with treatment and study site as factors and BL value as a covariate. A total of 459 subjects (DVS n = 300, placebo n = 149) completed questionnaires at BL and were included in the analysis. There were no significant differences between groups for demographic and BL characteristics. There were significant decreases from BL in POMS Total Mood Disturbances (TMD) scores at weeks 4 and 12 in all groups. Both DVS groups showed significantly greater improvement from baseline in TMD scores compared with placebo at weeks 4 (DVS 100 mg, P<0.001; DVS 150 mg, P=0.041) and 12 (DVS 100 mg, P<0.001; DVS 150 mg, P=0.045). The DVS 100-mg group had significant decreases compared with placebo in 4 of 6 POMS subscale scores (week 12, all comparisons, P<0.005). The DVS 150-mg group had significant reductions compared with placebo in 3 of 6 POMS subscale scores. All groups had a significant decrease from BL in GCS total scores at both time points. Improvement in the GCS total score was significantly greater for the DVS 100-mg and DVS 150-mg groups compared with placebo at weeks 4 and 12 (all comparisons, P≤0.001). DVS 100 mg significantly improved all subscale scores, except somatic symptoms, compared with placebo (week 12, all comparisons, P<0.03); DVS 150 mg significantly improved all subscale scores, except somatic symptoms and sexual interest (week 12, all comparisons, P≤0.001). DVS, an effective non-hormonal therapy for HFs, improves mood and climacteric symptoms in women with moderate-to-severe VMS. These data further support DVS 100 mg as the appropriate therapeutic dose.