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

OBJECTIVE: Two phase 3, randomized, placebo-controlled trials demonstrated that low-dose paroxetine 7.5 mg reduced the frequency and severity of vasomotor symptoms (VMS) associated with menopause and had a favorable tolerability profile. The impact of paroxetine 7.5 mg on body weight and sexual func...

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Autores principales: Portman, David J., Kaunitz, Andrew M., Kazempour, Kazem, Mekonnen, Hana, Bhaskar, Sailaja, Lippman, Joel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott-Raven Publishers 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4175016/
https://www.ncbi.nlm.nih.gov/pubmed/24552977
http://dx.doi.org/10.1097/GME.0000000000000210
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author Portman, David J.
Kaunitz, Andrew M.
Kazempour, Kazem
Mekonnen, Hana
Bhaskar, Sailaja
Lippman, Joel
author_facet Portman, David J.
Kaunitz, Andrew M.
Kazempour, Kazem
Mekonnen, Hana
Bhaskar, Sailaja
Lippman, Joel
author_sort Portman, David J.
collection PubMed
description OBJECTIVE: Two phase 3, randomized, placebo-controlled trials demonstrated that low-dose paroxetine 7.5 mg reduced the frequency and severity of vasomotor symptoms (VMS) associated with menopause and had a favorable tolerability profile. The impact of paroxetine 7.5 mg on body weight and sexual function was evaluated in a pooled analysis. METHODS: Postmenopausal women aged 40 years or older who had moderate to severe VMS were randomly assigned to receive paroxetine 7.5 mg or placebo once daily for 12 or 24 weeks. Assessments included changes in body mass index (BMI) and weight, Arizona Sexual Experiences Scale score, Hot Flash–Related Daily Interference Scale sexuality subscore, and adverse events related to weight or sexual dysfunction. RESULTS: Pooled efficacy and safety populations comprised 1,174 and 1,175 participants, respectively. Baseline values were similar for median weight (∼75 kg), median BMI (∼28 kg/m(2)), and the proportion of women with sexual dysfunction (∼58%). No clinically meaningful or statistically significant changes from baseline in weight or sexual function assessments occurred in the paroxetine 7.5 mg group. Small but statistically significant increases in weight and BMI were observed in the placebo group only on week 4. No significant difference between treatment groups was observed in the proportion of participants who had 7% or higher gain in body weight on week 4, 12, or 24. Rates of adverse events suggestive of sexual dysfunction were low and similar in both treatment groups. CONCLUSIONS: Paroxetine 7.5 mg does not cause weight gain or negative changes in libido when used to treat menopause-associated VMS in postmenopausal women.
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spelling pubmed-41750162014-09-26 Effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause Portman, David J. Kaunitz, Andrew M. Kazempour, Kazem Mekonnen, Hana Bhaskar, Sailaja Lippman, Joel Menopause Original Articles OBJECTIVE: Two phase 3, randomized, placebo-controlled trials demonstrated that low-dose paroxetine 7.5 mg reduced the frequency and severity of vasomotor symptoms (VMS) associated with menopause and had a favorable tolerability profile. The impact of paroxetine 7.5 mg on body weight and sexual function was evaluated in a pooled analysis. METHODS: Postmenopausal women aged 40 years or older who had moderate to severe VMS were randomly assigned to receive paroxetine 7.5 mg or placebo once daily for 12 or 24 weeks. Assessments included changes in body mass index (BMI) and weight, Arizona Sexual Experiences Scale score, Hot Flash–Related Daily Interference Scale sexuality subscore, and adverse events related to weight or sexual dysfunction. RESULTS: Pooled efficacy and safety populations comprised 1,174 and 1,175 participants, respectively. Baseline values were similar for median weight (∼75 kg), median BMI (∼28 kg/m(2)), and the proportion of women with sexual dysfunction (∼58%). No clinically meaningful or statistically significant changes from baseline in weight or sexual function assessments occurred in the paroxetine 7.5 mg group. Small but statistically significant increases in weight and BMI were observed in the placebo group only on week 4. No significant difference between treatment groups was observed in the proportion of participants who had 7% or higher gain in body weight on week 4, 12, or 24. Rates of adverse events suggestive of sexual dysfunction were low and similar in both treatment groups. CONCLUSIONS: Paroxetine 7.5 mg does not cause weight gain or negative changes in libido when used to treat menopause-associated VMS in postmenopausal women. Lippincott-Raven Publishers 2014-10 2014-09-17 /pmc/articles/PMC4175016/ /pubmed/24552977 http://dx.doi.org/10.1097/GME.0000000000000210 Text en © 2014 by The North American Menopause Society This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/3.0.
spellingShingle Original Articles
Portman, David J.
Kaunitz, Andrew M.
Kazempour, Kazem
Mekonnen, Hana
Bhaskar, Sailaja
Lippman, Joel
Effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause
title Effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause
title_full Effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause
title_fullStr Effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause
title_full_unstemmed Effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause
title_short Effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause
title_sort effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4175016/
https://www.ncbi.nlm.nih.gov/pubmed/24552977
http://dx.doi.org/10.1097/GME.0000000000000210
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