Effect of desvenlafaxine on mood and climacteric symptoms in menopausal women with moderate to severe vasomotor symptoms.
OBJECTIVE
To assess effects of desvenlafaxine (administered as desvenlafaxine succinate) on secondary outcomes of mood, climacteric symptoms, and treatment satisfaction in postmenopausal women with moderate to severe menopausal vasomotor symptoms (VMS).


METHODS
A 12-week, multicenter, double-blind, placebo-controlled trial was conducted in postmenopausal women with ≥ 50 moderate to severe hot flushes per week. Participants were randomly assigned to desvenlafaxine 100 mg/day, desvenlafaxine 150 mg/day, or placebo. Secondary outcome efficacy variables included Profile of Mood States (POMS), Greene Climacteric Scale (GCS), and Menopausal Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) scores. Change from baseline in POMS total mood disturbance (TMD) score and subdomain scores were evaluated using analysis of covariance, adjusting for treatment and study site as factors and baseline score. GCS total and subdomain scores were analyzed similarly. Treatment satisfaction was analyzed using the row mean score test.


RESULTS
A total of 458 women were enrolled. At week 12, desvenlafaxine 100 mg/day significantly improved POMS TMD scores (p <0.001) and four of six POMS subdomains compared with placebo (all p ≤ 0.005). Women taking desvenlafaxine 100 mg/day experienced significantly greater improvement in GCS total scores (p <0.001) and five of six subdomains (all p ≤ 0.029) compared with placebo. Treatment with desvenlafaxine 100 mg/day resulted in significantly greater treatment satisfaction overall and in six of seven additional MS-TSQ items (all p ≤0.042). Desvenlafaxine 150-mg/day results were similar.


CONCLUSIONS
Desvenlafaxine treatment improved mood and climacteric symptoms in postmenopausal women with moderate to severe VMS compared with placebo, and more women were satisfied with desvenlafaxine treatment than with placebo.
Pfizer Inc, formerly Wyeth Research, Collegeville, PA 19426, USA.
R J
RJ
Cheng
C
C
Dupont
D F
DF
Archer
W
W
Bao
J
J
Racketa
G
G
Constantine
J H
JH
Pickar
D000328:Adult; D000342:Affective Symptoms / Q000188:drug therapy*; D000368:Aged; D000786:Anger / Q000187:drug effects; D001007:Anxiety / Q000188:drug therapy; D001416:Back Pain / Q000188:drug therapy; D003221:Confusion / Q000188:drug therapy; D003511:Cyclohexanols / Q000494:pharmacology / Q000627:therapeutic use*; D003863:Depression / Q000188:drug therapy; D000069468:Desvenlafaxine Succinate; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D006945:Hyperhidrosis / Q000188:drug therapy; D007508:Irritable Mood / Q000187:drug effects; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D014179:Neurotransmitter Uptake Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D017060:Patient Satisfaction; D012725:Sexual Behavior / Q000187:drug effects; D011795:Surveys and Questionnaires
D003511:Cyclohexanols; D014179:Neurotransmitter Uptake Inhibitors; D000069468:Desvenlafaxine Succinate