Safety Profile of Paroxetine 7.5 mg in Women With Moderate-to-Severe Vasomotor Symptoms

Abstract

INTRODUCTION: Brisdelle (paroxetine) in 7.5-mg capsules is a new non-hormonal agent approved in the United States for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. The safety and tolerability of paroxetine 7.5 mg were evaluated in three multicenter, double-blind, randomized, placebo-controlled trials of 8 (phase 2), 12 (phase 3), and 24 weeks (phase 3) in duration. METHODS: Postmenopausal women 40 years of age and older with moderate-to-severe vasomotor symptoms (more than seven to eight hot flushes per day; 50–60 per week) entered a 7- to 12-day single-blind placebo run-in period and recorded vasomotor symptoms in daily electronic diaries. Compliant participants were randomized one-to-one to receive once-daily 7.5 mg paroxetine or placebo at bedtime. Treatment-emergent adverse events were assessed using standardized medical terminology (MedDRA). RESULTS: One thousand two hundred seventy-six women were included in the safety analysis. Overall, 50.4% of paroxetine-treated women and 47.0% receiving placebo reported at least one treatment-emergent adverse event. Treatment-emergent adverse events leading to discontinuation occurred in 4.7% of 7.5 mg paroxetine-treated women and 3.7% of placebo-treated women. One death was reported (12-week study) but was not considered treatment-related by the investigator. There were no notable differences between groups with regard to adverse events related to weight, libido, or sleep (Table 1).CONCLUSION: In these three controlled studies in postmenopausal women with moderate-to-severe vasomotor symptoms, 7.5 mg paroxetine had a favorable tolerability profile with an incidence of treatment-emergent adverse events comparable with placebo. Incidence of weight-, libido-, and sleep-related adverse events that commonly occur with higher doses of paroxetine used to treat psychiatric disorders was comparable with placebo.