Postmenopausal women aged 40–79 years (mean 54 years) who had moderate to severe vasomotor symptoms (VMS) were randomly assigned to receive paroxetine 7.5 mg or placebo once daily for 12 or 24 weeks [1]. Assessments included changes in body mass index (BMI) and weight, Arizona Sexual Experiences Scale score (ASEX), Hot Flash-Related Daily Interference Scale sexuality subscore, and adverse events related to weight or sexual dysfunction. Pooled efficacy and safety populations comprised 1174 and 1175 participants of two phase-3 studies. Baseline values were similar for median weight (~75 kg), median BMI (~28 kg/m), and the proportion of women with sexual dysfunction (~58%). No clinically meaningful or statistically significant changes from baseline in weight or sexual function assessments occurred in the paroxetine 7.5 mg group. Small but statistically significant increases in weight and BMI were observed in the placebo group only at week 4. No significant difference between treatment groups was observed in the proportion of participants who had 7% or higher gain in body weight at weeks 4, 12, or 24. Rates of adverse events suggestive of sexual dysfunction were low and similar in both treatment groups.
Author(s)
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Amos Pines
Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel
Citations
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Portman DJ, Kaunitz AM, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause. Menopause 2014 Feb 17. Epub ahead of print
http://www.ncbi.nlm.nih.gov/pubmed/24552977 -
Simon JA, Portman DJ, Kaunitz AM, et al. Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: two randomized controlled trials. Menopause 2013;20:1027-35
http://www.ncbi.nlm.nih.gov/pubmed/24045678 -
Prescribing information of paroxetine
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021299s024lbl.pdf -
Marks DM, Park MH, Ham BJ, et al. Paroxetine: safety and tolerability issues. Expert Opin Drug Saf 2008;7:783-94
http://www.ncbi.nlm.nih.gov/pubmed/18983224
