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

Portman, David; Kaunitz, Andrew M.; Kazempour, Kazem; Mekonnen, Hana; Bhaskar, Sailaja; Lippman, Joel

doi:10.1097/gme.0000000000000210

Cited by 22 publications

(19 citation statements)

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“…Supplementary publications from this study population presented results on sleep disturbances and evaluated the effect of treatment on weight and sexual dysfunction in a pooled analysis. 31 , 32 Patients reported a baseline mean of 3.6 awakenings per night due to VMS. They found a significant reduction in nighttime awakening due to VMS at 4 weeks (39% reduction for paroxetine vs 28% placebo; P =0.0049), and these results were sustained through the 24-week treatment period (62% reduction for paroxetine vs 43% placebo; P <0.0001).…”

Section: Study Populations Primarily Without Breast Cancermentioning

confidence: 99%

Critical appraisal of paroxetine for the treatment of vasomotor symptoms

Carroll¹,

Lisenby²,

Carter³

2015

IJWH

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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.

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Section: Study Populations Primarily Without Breast Cancermentioning

confidence: 99%

Critical appraisal of paroxetine for the treatment of vasomotor symptoms

Carroll¹,

Lisenby²,

Carter³

2015

IJWH

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“… 30 Furthermore, treatment with paroxetine 7.5 mg did not result in adverse events (AEs) such as weight gain and sexual dysfunction, which are commonly associated with higher-dose selective serotonin reuptake inhibitors (SSRIs). 33 …”

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confidence: 99%

Low-dose paroxetine (7.5 mg) improves sleep in women with vasomotor symptoms associated with menopause

Pinkerton

Joffe

Kazempour³

et al. 2015

Menopause

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ObjectiveSleep disturbances are common among women in midlife; prevalence increases among perimenopausal/postmenopausal women with vasomotor symptoms. Paroxetine 7.5 mg is the only nonhormonal treatment that has been approved in the United States for moderate to severe vasomotor symptoms associated with menopause. In two pivotal phase 3 studies evaluating its efficacy and safety, improvements in sleep disturbances were also prospectively evaluated.MethodsPostmenopausal women with moderate to severe vasomotor symptoms were randomly assigned to paroxetine 7.5 mg (n = 591) or placebo (n = 593) once daily for 12 weeks (both studies) or 24 weeks (24-wk study). Predefined assessments on weeks 4, 12, and 24 included number of nighttime awakenings attributed to vasomotor symptoms, sleep-onset latency, sleep duration, and sleep-related adverse events. The two studies’ data for weeks 1 to 12 were pooled.ResultsAt baseline, participants reported a mean of 3.6 awakenings/night attributed to vasomotor symptoms. Nighttime awakenings attributed to vasomotor symptoms were significantly reduced within 4 weeks of initiating paroxetine 7.5 mg treatment (39% reduction vs 28% for placebo; P = 0.0049), and reductions were sustained through 12 or 24 weeks of treatment. Paroxetine 7.5 mg treatment also significantly increased nighttime sleep duration (week 4, +31 vs +16 min for placebo; P = 0.0075), but no significant between-group differences in sleep-onset latency or sleep-related adverse events such as sedation were observed.ConclusionsIn postmenopausal women treated for menopausal vasomotor symptoms, paroxetine 7.5 mg significantly reduces the number of nighttime awakenings attributed to vasomotor symptoms and increases sleep duration without differentially affecting sleep-onset latency or sedation.

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“…A pooled analysis of two phase 3 studies reported that postmenopausal women treated with paroxetine 7.5 mg up to 24 weeks did not experience increases in weight or BMI that differed significantly from placebo. 28 The labels for some of the other nonhormonal treatments (eg, gabapentin, venlafaxine, clonidine) report weight gain as an adverse event, [29][30][31] whereas others (eg, fluoxetine, citalopram) report weight loss as an adverse event. 32,33 A marginal, but statistically significant interaction was found between baseline BMI and change in hot flush severity with CE/BZA.…”

Section: Black Et Almentioning

confidence: 99%