FDA Approval of Paroxetine for Menopausal Hot Flushes

Orleans, Ronald J.; Li, Li; Kim, Myong‐Jin; Guo, Jia; Sobhan, Mahboob; Soule, Lisa; Joffe, Hylton V.

doi:10.1056/nejmp1402080

Cited by 66 publications

(36 citation statements)

References 5 publications

(3 reference statements)

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“…Given the strong association between hot flashes and somatic anxiety, which reflects a trait-like cognitive condition, cognitive-behavioral therapy (CBT), which reduced anxiety sensitivity compared to control conditions in a meta-analysis of CBT, may be an important treatment to consider, although more studies are needed to confirm current information. 41 The strong association between anxiety and hot flashes may also partly explain why selective serotonin reuptake inhibitors, which are indicated for treatment of anxiety, have shown modest efficacy for hot flashes 32–36 and are considered a possible alternative to hormone therapy. 37 Gabapentin is another medication that has been shown to reduce both hot flashes and anxiety symptoms and may provide therapeutic benefit, 38–40 although confirmatory studies are needed for these preliminary findings.…”

Section: Discussionmentioning

confidence: 99%

Anxiety as a risk factor for menopausal hot flashes: evidence from the Penn Ovarian Aging cohort

Freeman¹,

Sammel

2016

Menopause

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Objective The aim of this study was to identify temporal associations of anxiety dimensions with menopausal hot flashes in women progressing through the menopause transition. We hypothesized that associations of both somatic and affective dimensions of anxiety with hot flashes increased in the menopause transition, and that somatic anxiety was an independent risk factor for menopausal hot flashes. Methods Hot flashes, anxiety symptoms, hormone levels and other psychosocial variables were assessed annually for 14 years of follow-up. The 233 women were premenopausal at baseline and continued through one year or more after the final menstrual period. Anxiety dimensions were assessed with the Zung Anxiety Scale (ZAS), a validated measure of affective anxiety and somatic anxiety. Summed item scores were divided by the number of items rated, so that ranges of the two dimensions were comparable. Results Seventy-two percent of the sample reported moderate/severe hot flashes during the 14-year interval. There was no significant interaction between anxiety dimensions and menopausal stages. However, when adjusted for menopausal stage, the magnitude of association between somatic anxiety and hot flashes dramatically increased (OR 3.03, 95% CI: 2.12, 4.32, P<0.001), while the association between affective anxiety and hot flashes increased to a lesser extent (OR 1.27, 95% CI: 1.03, 1.57, P=0.024). Women with high levels of somatic anxiety (top third of the sample) had the greatest risk of hot flashes (P<0.001). When the anxiety dimensions were considered in combination, the additive effect of high affective anxiety symptoms was minimal, with no significant difference between the group with high affective/low somatic symptoms and the low symptom group in incident hot flashes at each menopausal stage (P=0.54). In multivariable analysis, somatic anxiety increased the risk of hot flashes more than 3 times (OR 3.13, 95% CI: 2.16, 4.53, P<0.001), but affective anxiety was not significantly associated with hot flashes after adjustment for other study variables (OR 1.19, 95% CI: 0.96, 1.48, P=0.117). Time-lagged somatic anxiety scores significantly predicted hot flashes, with a 71% increase in risk (OR 1.71, 95% CI: 1.21, 2.41, P=0.002). Time-lagged affective anxiety scores did not predict hot flashes, (OR 1.06, 95% CI: 0.87, 1.31, P=0.58). Conclusions This study showed a strong predictive association of somatic anxiety with the risk of menopausal hot flashes. The temporal associations suggest that somatic anxiety is not simply a redundant measure of hot flashes but predicts the risk of menopausal hot flashes and may be a potential target in clinical management of perimenopausal women.

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Section: Discussionmentioning

confidence: 99%

Anxiety as a risk factor for menopausal hot flashes: evidence from the Penn Ovarian Aging cohort

Freeman¹,

Sammel

2016

Menopause

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“…SSRIs, such as paroxetine, escitalopram, citalopram and sertraline have been studied and are effective in decreasing both frequency and severity of hot flushes [22]. Of the SSRIs, paroxetine seems to have the best evidence base of efficacy [23][24][25] and was recently approved by Food and Drug Administration (FDA) for the treatment of menopausal hot flushes [26]. SNRIs (venlafaxine, desvenlafaxine) have been used to treat menopausal symptoms, mainly in women in whom MHT is contraindicated [27][28][29].…”

Section: Non-hormonal Pharmacological Interventionsmentioning

confidence: 99%

EMAS position statement: Non-hormonal management of menopausal vasomotor symptoms

Mintziori¹,

Lambrinoudaki²,

Goulis³

et al. 2015

Maturitas

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“…20 In 2014, the FDA approved the use of paroxetine for menopausal hot flushes, which occur in as many as 75% of menopausal women. 21 Paroxetine is in the most commonly prescribed class of antidepressants, selective serotonin reuptake inhibitors (SSRIs). SRRIs as a class have been associated with increases in ischemic stroke risk in several observational studies 22–25 and may also increase cardiovascular morbidity and mortality.…”

Section: Introductionmentioning

confidence: 99%

Long-term sertraline treatment and depression effects on carotid artery atherosclerosis in premenopausal female primates

et al. 2017

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Objective Atherosclerosis developed during premenopausal years predicts postmenopausal atherosclerosis burden. Selective serotonin reuptake inhibitor (SSRI) antidepressants, recently approved for hot flushes, have been associated with increased ischemic stroke risk in several observational studies; however effects on carotid artery atherosclerosis, a strong predictor of future vascular events, are unknown. Methods The effects of chronic administration of a commonly prescribed SSRI, sertraline HCl, on atherosclerosis in the carotid artery was assessed in a placebo-controlled, longitudinal, randomized study of premeonopausal depressed and nondepressed cynomolgus monkeys (Macaca fascicularis; n=42). Physiologic and behavioral phenotypes were evaluated at baseline and after 18-months of oral sertraline (20 mg/kg, n=21) or placebo (n=21). Carotid artery atherosclerosis was measured post-mortem via histomorphometry. Results Atherosclerosis extent in the right common carotid artery, on average, was 60% greater in sertraline-treated depressed monkeys compared to all other groups (p=0.028). The results of linear regression analyses suggested that sertraline and depression effects on atherosclerosis were not mediated by their effects on behavioral and physiological risk factors. Conclusions These findings suggest that chronic SSRI treatment is associated with the progression of carotid artery atherosclerosis, which may increase the risk for future vascular events, particularly in depressed women. The underlying mechanism remains to be determined, but does not appear to be related to SSRI effects on traditional cardiovascular risk factors.

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FDA Approval of Paroxetine for Menopausal Hot Flushes

Cited by 66 publications

References 5 publications

Anxiety as a risk factor for menopausal hot flashes: evidence from the Penn Ovarian Aging cohort

Anxiety as a risk factor for menopausal hot flashes: evidence from the Penn Ovarian Aging cohort

EMAS position statement: Non-hormonal management of menopausal vasomotor symptoms

Long-term sertraline treatment and depression effects on carotid artery atherosclerosis in premenopausal female primates

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