Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms

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

doi:10.1097/gme.0b013e3182a66aa7

Cited by 122 publications

(136 citation statements)

References 23 publications

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“…7,9 However, eligibility criteria in previous trials varied widely and doses of ET differed, precluding direct comparison. In contrast to previous ET trial eligibility criteria of 7+ moderate-to-severe VMS/day, 6,22,23 we required fewer VMS (2+/day) and not all VMS were required to be moderate or severe.…”

Section: Discussionmentioning

confidence: 99%

“…Many SSRI/SNRI have been shown to be more effective than placebo in reducing VMS, 7–9 with one SSRI recently FDA-approved to treat VMS. 3,9 The SNRI venlafaxine is one of the most widely studied serotonergic agents with accumulating evidence showing that low doses (75–150 mg/day) reduce VMS more than placebo. 10–12 SSRI/SNRI are used widely to treat VMS, with venlafaxine a first-line treatment in women unable or unwilling to take ET.…”

Section: Introductionmentioning

confidence: 99%

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Low-Dose Estradiol and the Serotonin-Norepinephrine Reuptake Inhibitor Venlafaxine for Vasomotor Symptoms

et al. 2014

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IMPORTANCE Estrogen therapy is the gold standard treatment for hot flashes and night sweats, but some women are unable or unwilling to use it because of associated risks. The serotonin-norepinephrine reuptake inhibitor venlafaxine hydrochloride is used widely as a nonhormonal treatment. While the clinical impression is that serotonin-norepinephrine reuptake inhibitors are less effective than estrogen, these medications have not been simultaneously evaluated in one clinical trial to date. OBJECTIVE To determine the efficacy and tolerability of low-dose oral 17β-estradiol and low-dose venlafaxine extended release in alleviating vasomotor symptoms (VMS). DESIGN, SETTING, AND PARTICIPANTS In total, 339 perimenopausal and postmenopausal women with at least 2 bothersome VMS per day (mean, 8.1 per day) were recruited from the community to MsFLASH (Menopause Strategies: Finding Lasting Answers for Symptoms and Health) clinical network sites between December 5, 2011, and October 15, 2012. INTERVENTIONS Participants were randomized to double-blind treatment with low-dose oral 17β-estradiol (0.5 mg/d) (n = 97), low-dose venlafaxine hydrochloride extended release (75 mg/d) (n = 96), or placebo (n = 146) for 8 weeks. MAIN OUTCOMES AND MEASURESThe primary outcome was the mean daily frequency of VMS after 8 weeks of treatment. Secondary outcomes were VMS severity, bother, and interference with daily life. Intent-to-treat analyses compared the change in VMS frequency between each active intervention and placebo and between the 2 active treatments.RESULTS Compared with baseline, the mean VMS frequency at week 8 decreased to 3.9 (95% CI, 2.9-4.9) VMS per day (52.9% reduction) in the estradiol group, to 4.4 (95% CI, 3.5-5.3) VMS per day (47.6% reduction) in the venlafaxine group, and to 5.5 (95% CI, 4.7-6.3) VMS per day (28.6% reduction) in the placebo group. Estradiol reduced the frequency of symptoms by 2.3 more per day than placebo (P < .001), and venlafaxine reduced the frequency of symptoms by 1.8 more per day than placebo (P = .005). The results were consistent for VMS severity, bother, and interference. Low-dose estradiol reduced the frequency of symptoms by 0.6 more per day than venlafaxine (P = .09). Treatment satisfaction was highest (70.3%) for estradiol (P < .001 vs placebo), lowest (38.4%) for placebo, and intermediate (51.1%) for venlafaxine (P = .06 vs placebo). Both interventions were well tolerated.CONCLUSIONS AND RELEVANCE Low-dose oral estradiol and venlafaxine are effective treatments for VMS in women during midlife. While the efficacy of low-dose estradiol may be slightly superior to that of venlafaxine, the difference is small and of uncertain clinical relevance.TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01418209

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Low-Dose Estradiol and the Serotonin-Norepinephrine Reuptake Inhibitor Venlafaxine for Vasomotor Symptoms

et al. 2014

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“…Methodologies for the 12-week and 24-week studies, including participant inclusion and exclusion criteria, study designs, primary efficacy endpoints, and statistical analyses, have been previously described in detail 17. Both studies were conducted in postmenopausal women with moderate to severe VMS associated with menopause.…”

Section: Methodsmentioning

confidence: 99%

“…Brisdelle (paroxetine 7.5 mg; previously called low-dose mesylate salt of paroxetine) is the first and only US Food and Drug Administration–approved nonhormonal option for the treatment of moderate to severe VMS associated with menopause. Two phase 3 studies (ClinicalTrials.gov identifiers NCT01361308 and NCT01101841) demonstrated that paroxetine 7.5 mg reduced moderate to severe VMS in postmenopausal women and was well tolerated 17. Using pooled data from the two phase 3 studies, we examined whether treatment with paroxetine 7.5 mg affected weight, sexual function, or both.…”

mentioning

confidence: 99%

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

Portman

Kaunitz

Kazempour³

et al. 2014

Menopause

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“…Increased testing of non-hormonal treatments for vasomotor symptoms (3–6) has followed the publication of WHI results, and the FDA recently approved one selective serotonin reuptake inhibitor for vasomotor symptom treatment (6, 7). …”

Section: Introductionmentioning

confidence: 99%

Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms

Guthrie

LaCroix

Ensrud

et al. 2015

Obstetrics &Amp; Gynecology

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Objective To describe the effects of six interventions for menopausal vasomotor symptoms relative to control in a pooled analysis, facilitating translation of the results for clinicians and symptomatic women. The MsFLASH (Menopause Strategies: Finding Lasting Answers for Symptoms and Health) network tested these interventions in three randomized clinical trials (RCTs). Methods An analysis of pooled individual-level data from three RCTs is presented. Participants were 899 peri- and postmenopausal women with at least 14 bothersome vasomotor symptoms/week. Interventions included escitalopram 10–20 mg/day, non-aerobic yoga, aerobic exercise, 1.8 g/day omega-3 fatty acid supplementation, low-dose oral 17-beta-estradiol 0.5-mg/day, and low-dose venlafaxine XR 75-mg/day. The main outcome measures were changes from baseline in mean daily vasomotor symptoms frequency and bother during 8–12 weeks of treatment. Linear regression models estimated differences in outcomes between each intervention and corresponding control group, adjusted for baseline characteristics. Models included trial-specific intercepts, effects of the baseline outcome measure, and time. Results The 8-week reduction in vasomotor symptoms frequency from baseline relative to placebo was similar for escitalopram at −1.4/day (95% CI: −2.7 to −0.2), low-dose estradiol at −2.4 (95% CI: −3.4 to −1.3), and venlafaxine at −1.8 (95% CI: −2.8 to −0.8); vasomotor symptoms bother reduction was minimal and did not vary across these three pharmacologic interventions (means −0.2 to −0.3 relative to placebo). No effects on vasomotor symptoms frequency or bother were seen with aerobic exercise, yoga or omega-3 supplements. Conclusions These analyses suggest that escitalopram, low-dose estradiol, and venlafaxine provide comparable, modest reductions in vasomotor symptoms frequency and bother among women with moderate hot flushes. Clinical Trial Registration ClinicalTrials.gov, www.clinicaltrials.gov, NCT00894543 (MsFLASH 01), NCT01178892 (MsFLASH 02), and NCT01418209 (MsFLASH 03).

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Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms

Abstract: Paroxetine 7.5 mg is well-tolerated, is effective in reducing the frequency and severity of menopausal vasomotor symptoms, and demonstrates persistence of treatment benefit through 24 weeks of treatment.

Cited by 122 publications

References 23 publications

Low-Dose Estradiol and the Serotonin-Norepinephrine Reuptake Inhibitor Venlafaxine for Vasomotor Symptoms

Low-Dose Estradiol and the Serotonin-Norepinephrine Reuptake Inhibitor Venlafaxine for Vasomotor Symptoms

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

Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms

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