Critical appraisal of paroxetine for the treatment of vasomotor symptoms

Abstract

BackgroundVasomotor symptoms (VMS), characterized by hot flashes and night sweats, are the most commonly reported symptoms associated with estrogen deficiency during menopause and occur in up to 70% of women. The goal of treatment is to reduce the frequency and severity of symptoms. Although hormone therapy (HT) is generally recommended as first-line treatment, it is not appropriate for all patients. Antidepressants, specifically selective serotonin reuptake inhibitors, have been evaluated and utilized internationally for alternative treatment for VMS. In 2013, paroxetine mesylate (Brisdelle®) received a US Food and Drug Administration-labeled indication for moderate-to-severe hot flashes, making it the first nonhormonal treatment for VMS associated with menopause. The objective of this review is to critically evaluate available clinical data regarding the efficacy and safety of paroxetine for the treatment of VMS in menopausal women.MethodsMEDLINE, PubMed, and Google Scholar were searched using the keywords paroxetine, vasomotor symptoms, hot flashes, and menopause. Searches were limited to humans, English language, and clinical trial design with a primary outcome of hot flash/vasomotor changes.ResultsParoxetine (hydrochloride and mesylate) has been associated with a 33%–67% reduction in hot flash frequency with 6–12 weeks of treatment compared to 13.7%–37.8% reductions with placebo in patients both with and without a history of breast cancer. It was also associated with significant reductions in hot flash severity. Benefits of treatment persisted through 24 weeks in the study of the longest duration. Most adverse effects reported were of mild-to-moderate severity, with improved tolerability associated with lower doses (7.5–12.5 mg/day).ConclusionParoxetine is a safe and effective therapy for the treatment of VMS during menopause. Paroxetine (7.5–12.5 mg/day) should be considered a first-line therapy option for VMS in patients when HT is either inappropriate or intolerable.

Effect and safety of paroxetine for vasomotor symptoms: systematic review and meta‐analysis

“…This is in addition to the three wide‐ranging reviews conducted before the licensing of Brisdelle . Both of these recent reviews included most of the six trials we identified, plus some others, and reached similar conclusions . However, our review has several advantages over the others that enhance the reliability and interpretation of the data.…”

“…Thirdly, we have used the GRADE approach to rate the quality of evidence, which helps in the interpretation of the results of the systematic review. Although the results of the two recent reviews and this review are similar, the interpretation using GRADE clarifies the evidence.…”

“…Recently, two reviews have been published in peer‐review journals concerning the effectiveness and safety of paroxetine for VMS . This is in addition to the three wide‐ranging reviews conducted before the licensing of Brisdelle .…”

Bazedoxifene and Conjugated Equine Estrogen: A Combination Product for the Management of Vasomotor Symptoms and Osteoporosis Prevention Associated with Menopause

“…For example, compared with the 75% reduction in VMS frequency and 89% reduction in VMS severity observed with HT, 2 gabapentin results in a 45% reduction in frequency and 54% reduction in severity . After 6–12 weeks of treatment, paroxetine treatment results in a 33–67% reduction in frequency and desvenlafaxine results in a 65% reduction in frequency . Gabapentin and paroxetine have been compared with each other, with clinical trial results illustrating a 55–68% reduction in VMS with gabapentin compared with a 20–23% reduction with paroxetine.…”

American Association of Clinical Endocrinologists and American College of Endocrinology Position Statement on Menopause–2017 Update

“…In a separate study, paroxetine 7.5 mg daily was shown to improve hot flashes without weight gain or sexual dysfunction (45).…”