title: Effects of low-dose paroxetine 7.5 mg on weight and sexual function during treatment of vasomotor symptoms associated with menopause.
abstract: 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), 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.
authors.affiliation: From the 1Columbus Center for Women's Health Research, Columbus, OH; 2University of Florida College of Medicine, Jacksonville, FL; 3Amarex Clinical Research, Germantown, MD; and 4Noven Pharmaceuticals Inc, New York, NY.
authors.forename: David J
authors.initials: DJ
authors.lastname: Portman
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Kaunitz
authors.forename: Kazem
authors.initials: K
authors.lastname: Kazempour
authors.forename: Hana
authors.initials: H
authors.lastname: Mekonnen
authors.forename: Sailaja
authors.initials: S
authors.lastname: Bhaskar
authors.forename: Joel
authors.initials: J
authors.lastname: Lippman
mesh_terms: D000328:Adult; D000368:Aged; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D017374:Paroxetine / Q000008:administration & dosage / Q000009:adverse effects*; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage*; D012735:Sexual Dysfunction, Physiological / Q000139:chemically induced / Q000453:epidemiology* / Q000503:physiopathology; D016037:Single-Blind Method
chemical_list: D017374:Paroxetine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors