title: Low-dose paroxetine 7.5 mg for menopausal vasomotor symptoms: two randomized controlled trials.
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.affiliation: 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.
authors.forename: James A
authors.initials: JA
authors.lastname: Simon
authors.forename: David J
authors.initials: DJ
authors.lastname: Portman
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Kaunitz
authors.forename: Hana
authors.initials: H
authors.lastname: Mekonnen
authors.forename: Kazem
authors.initials: K
authors.lastname: Kazempour
authors.forename: Sailaja
authors.initials: S
authors.lastname: Bhaskar
authors.forename: Joel
authors.initials: J
authors.lastname: Lippman
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D017374:Paroxetine / Q000008:administration & dosage* / Q000009:adverse effects; D010919:Placebos; D017698:Postmenopause; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D017374:Paroxetine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors