Paroxetine administered in low doses to treat vasomotor symptoms associated with menopause did not yield significant changes in body weight or sexual function, according to pooled phase 3 results published in Menopause.
The findings came from two randomized, placebo-controlled trials looking at the effects of paroxetine 7.5 mg (Brisdelle, Noven Therapeutics), a selective serotonin reuptake inhibitor (SSRI), on postmenopausal women with moderate to severe vasomotor systems during 4, 12 and 24 weeks.
“Compared with baseline, no clinically relevant differences in body weight and BMI, or in reports of decreased libido or altered sexual functioning, were observed between treatment arms over time,” the researchers wrote.
The analysis by David J. Portman, MD, of the Columbus Center for Women’s Health Research, Ohio, and colleagues included assessments of changes in BMI and body weight, Arizona Sexual Experiences Scale score, Hot Flash-Related Daily Interference Scale sexuality subscore and adverse events related to weight or sexual dysfunction.
David J. Portman
The women recruited were experiencing more than seven to eight hot flashes per day, or 50 to 60 per week, in the month preceding screening. After a 12-day, single blind, placebo-controlled run-in period, those compliant with electronic diary entry and still meeting hot flash eligibility criteria were assigned 1:1 to paroxetine 7.5 mg or placebo once daily at bedtime.
The efficacy population (n=1,174) and safety population (n=1,175) had similar baseline values for median weight (approximately 75 kg) and median BMI (approximately 28 kg/m2); the proportion of women with sexual dysfunction was approximately 58%.
No clinically meaningful or statistically significant changes in weight or sexual function assessments were observed with paroxetine from baseline. Small but statistically significant increases in weight and BMI were demonstrated by the placebo group, but only at 4 weeks. No significant between-group differences were seen in the proportion of women with ≥7% gain in body weight on week 4, 12 or 24. Rates for adverse events suggestive of sexual dysfunction were similarly low with paroxetine and placebo.
The researchers noted limitations of the study, including short treatment duration and follow-up period.
“Several studies of SSRIs and [serotonin-norepinephrine reuptake inhibitors] have reported stable weight or even small weight losses during short-term treatment (4-6 months) and increases in weight across a longer trial duration (≥12 months),” the researchers wrote. “The impact of paroxetine 7.5 mg on body weight and sexual function for a treatment duration longer than 24 weeks is unknown.”
Disclosure: Portman reports various financial ties to Noven. See the study for a full list of researchers’ financial disclosures.