Effect of desvenlafaxine on mood and climacteric symptoms in menopausal women with moderate to severe vasomotor symptoms

ABSTRACT

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.

Key words::

• MENOPAUSE
• MOOD DISTURBANCE
• CLIMACTERIC
• SEROTONIN NOREPINEPHRINE REUPTAKE INHIBITOR
• VASOMOTOR SYMPTOMS

Acknowledgements

Medical writing support was provided by Kathleen Dorries, PhD, and medical editing support by Agnes Puchnowski, MA, both of Embryon, and was funded by Pfizer Inc. The authors would like to acknowledge Sophie Olivier, MD, formerly of Wyeth Research, for her contribution to this study.

Conflict of interest Drs Cheng and Bao are full-time employees of Pfizer Inc. Dr DuPont has no conflicts of interest to declare. Dr Archer is a consultant for the following companies: Abbott Laboratories, Agile Therapeutics, Bayer Healthcare, CHEMO, Corcept, Merck (previously Schering Plough), Organon, and Pfizer Inc (previously Wyeth Laboratories). He has received research support from the following companies: Bayer Healthcare, Duramed, Warner Chilcott, Watson Pharmaceuticals, and Pfizer Inc (formerly Wyeth Laboratories). Jill Racketa is a former Pfizer Inc employee. Dr Constantine is a former Wyeth employee. Dr Pickar is a former employee of Wyeth Research and has served as a consultant for Wyeth, Depomed, BHR Pharma, Bionovo, and ASCEND Therapeutics.

Source of funding This study was sponsored by Wyeth Research, Collegeville, Pennsylvania, which was acquired by Pfizer Inc in October 2009.