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Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: two randomized controlled trials.
Menopause. 2013 Oct; 20(10):1027-35.M

Abstract

OBJECTIVE

The efficacy and safety of low-dose paroxetine 7.5 mg for the treatment of menopausal vasomotor symptoms were evaluated in two multicenter, double-blind, placebo-controlled, phase 3 studies of 12 and 24 weeks' duration.

METHODS

Postmenopausal women were randomly assigned 1:1 to receive paroxetine 7.5 mg or placebo once daily. The four primary efficacy endpoints included mean changes in the frequency and severity of moderate to severe vasomotor symptoms on weeks 4 and 12; an additional endpoint was persistence of treatment benefit on week 24.

RESULTS

Five hundred ninety-one participants were randomly assigned to treatment with paroxetine 7.5 mg, and 593 participants were randomly assigned to treatment with placebo. All primary endpoints were met in the 24-week study; three of four primary endpoints were met in the 12-week study. In both studies, paroxetine 7.5 mg significantly reduced the mean weekly vasomotor symptom frequency compared with placebo on week 4 (P < 0.0001 for both studies) and week 12 (P = 0.0090, 12-wk study; P = 0.0001, 24-wk study). Mean weekly reduction in vasomotor symptom severity was significantly greater for paroxetine 7.5 mg than for placebo on week 4 (P = 0.0048) in the 12-week study and on week 4 (P = 0.0452) and week 12 (P = 0.0114) in the 24-week study. Persistence of treatment benefit was demonstrated in the 24-week study. Most treatment-emergent adverse events were mild or moderate in severity. No clinically significant changes in laboratory values or vital signs were noted, and no short-term discontinuation of symptoms followed treatment cessation.

CONCLUSIONS

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.

Authors+Show Affiliations

From the 1George Washington University School of Medicine and Women's Health and Research Consultants, Washington, DC; 2Columbus Center for Women's Health Research, Columbus, OH; 3University of Florida College of Medicine, Jacksonville, FL; 4Amarex Clinical Research, Germantown, MD; and 5Noven Pharmaceuticals Inc, New York, NY.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24045678

Citation

Simon, James A., et al. "Low-dose Paroxetine 7.5 Mg for Menopausal Vasomotor Symptoms: Two Randomized Controlled Trials." Menopause (New York, N.Y.), vol. 20, no. 10, 2013, pp. 1027-35.
Simon JA, Portman DJ, Kaunitz AM, et al. Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: two randomized controlled trials. Menopause. 2013;20(10):1027-35.
Simon, J. A., Portman, D. J., Kaunitz, A. M., Mekonnen, H., Kazempour, K., Bhaskar, S., & Lippman, J. (2013). Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: two randomized controlled trials. Menopause (New York, N.Y.), 20(10), 1027-35. https://doi.org/10.1097/GME.0b013e3182a66aa7
Simon JA, et al. Low-dose Paroxetine 7.5 Mg for Menopausal Vasomotor Symptoms: Two Randomized Controlled Trials. Menopause. 2013;20(10):1027-35. PubMed PMID: 24045678.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: two randomized controlled trials. AU - Simon,James A, AU - Portman,David J, AU - Kaunitz,Andrew M, AU - Mekonnen,Hana, AU - Kazempour,Kazem, AU - Bhaskar,Sailaja, AU - Lippman,Joel, PY - 2013/9/19/entrez PY - 2013/9/21/pubmed PY - 2014/4/23/medline SP - 1027 EP - 35 JF - Menopause (New York, N.Y.) JO - Menopause VL - 20 IS - 10 N2 - OBJECTIVE: The efficacy and safety of low-dose paroxetine 7.5 mg for the treatment of menopausal vasomotor symptoms were evaluated in two multicenter, double-blind, placebo-controlled, phase 3 studies of 12 and 24 weeks' duration. METHODS: Postmenopausal women were randomly assigned 1:1 to receive paroxetine 7.5 mg or placebo once daily. The four primary efficacy endpoints included mean changes in the frequency and severity of moderate to severe vasomotor symptoms on weeks 4 and 12; an additional endpoint was persistence of treatment benefit on week 24. RESULTS: Five hundred ninety-one participants were randomly assigned to treatment with paroxetine 7.5 mg, and 593 participants were randomly assigned to treatment with placebo. All primary endpoints were met in the 24-week study; three of four primary endpoints were met in the 12-week study. In both studies, paroxetine 7.5 mg significantly reduced the mean weekly vasomotor symptom frequency compared with placebo on week 4 (P < 0.0001 for both studies) and week 12 (P = 0.0090, 12-wk study; P = 0.0001, 24-wk study). Mean weekly reduction in vasomotor symptom severity was significantly greater for paroxetine 7.5 mg than for placebo on week 4 (P = 0.0048) in the 12-week study and on week 4 (P = 0.0452) and week 12 (P = 0.0114) in the 24-week study. Persistence of treatment benefit was demonstrated in the 24-week study. Most treatment-emergent adverse events were mild or moderate in severity. No clinically significant changes in laboratory values or vital signs were noted, and no short-term discontinuation of symptoms followed treatment cessation. CONCLUSIONS: 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. SN - 1530-0374 UR - https://www.unboundmedicine.com/medline/citation/24045678/Low_dose_paroxetine_7_5_mg_for_menopausal_vasomotor_symptoms:_two_randomized_controlled_trials_ L2 - https://doi.org/10.1097/GME.0b013e3182a66aa7 DB - PRIME DP - Unbound Medicine ER -