Effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause

Abstract

Objective: Two phase 3, randomized, placebo-controlled trials demonstrated that low-dose paroxetine 7.5 mg reduced the frequency and severity of vasomotor symptoms (VMS) associated with menopause and had a favorable tolerability profile. The impact of paroxetine 7.5 mg on body weight and sexual function was evaluated in a pooled analysis.

Methods: Postmenopausal women aged 40 years or older who had moderate to severe VMS were randomly assigned to receive paroxetine 7.5 mg or placebo once daily for 12 or 24 weeks. Assessments included changes in body mass index (BMI) and weight, Arizona Sexual Experiences Scale score, Hot Flash-Related Daily Interference Scale sexuality subscore, and adverse events related to weight or sexual dysfunction.

Results: Pooled efficacy and safety populations comprised 1,174 and 1,175 participants, respectively. 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 on week 4. No significant difference between treatment groups was observed in the proportion of participants who had 7% or higher gain in body weight on week 4, 12, or 24. Rates of adverse events suggestive of sexual dysfunction were low and similar in both treatment groups.

Conclusions: Paroxetine 7.5 mg does not cause weight gain or negative changes in libido when used to treat menopause-associated VMS in postmenopausal women.

Trial registration: ClinicalTrials.gov NCT01101841 NCT01361308.

FIG. 1

Study design and timing of evaluations. AE, adverse event; ASEX, Arizona Sexual Experiences Scale; HFRDIS, Hot Flash–Related Daily Interference Scale.

FIG. 2

Impact of treatment on body mass index (BMI). P values were calculated from rank-transformed analysis of covariance.

FIG. 3

Impact of treatment on sexual dysfunction. P values were not significant versus placebo for all comparisons. ASEX, Arizona Sexual Experiences Scale.

FIG. 4

Arizona Sexual Experiences Scale (ASEX) score reductions in hot flash responders and hot flash nonresponders in the paroxetine 7.5 mg group. Responders were defined as women who achieved a 50% or higher reduction in moderate to severe hot flash frequency from baseline. P values are the results of Wilcoxon test.