title: The effect of conjugated estrogens/bazedoxifene therapy on body weight of postmenopausal women: pooled analysis of five randomized, placebo-controlled trials.
abstract: OBJECTIVE
  This post hoc analysis compared body weight, body mass index (BMI), and BMI category changes in postmenopausal women treated with conjugated estrogens/bazedoxifene (CE/BZA) versus placebo in the Selective Estrogens, Menopause, and Response to Therapy (SMART) trials.
  
  
  METHODS
  Data were pooled from five randomized, double-blind, placebo- and active-controlled studies in postmenopausal women aged 40 to 75 years with a uterus given CE 0.45 mg/BZA 20 mg (n = 1,607), CE 0.625 mg/BZA 20 mg (n = 1,598), or placebo (n = 1,256) for at least 12 weeks and up to 2 years. Changes from baseline in body weight, BMI (kg/m(2)), and World Health Organization BMI category (underweight <18.5; normal 18.5 to <25; overweight 25 to <30; obese ≥30) during treatment were evaluated.
  
  
  RESULTS
  Mean body weight increased less than 0.9 kg and mean BMI increased less than 0.4 kg/m(2) in all treatment groups at all time points. There were no statistically significant between-group differences, except for significantly greater increases in weight (P = 0.015) and BMI (P = 0.014) with placebo versus CE 0.625 mg/BZA 20 mg at month 12. Approximately, 10% of women in the CE/BZA groups and 11% in the placebo group had increases in body weight greater than 7% of baseline. The majority of BMI changes were within ±7%, and there were no statistically significant between-group differences in BMI category distributions during treatment.
  
  
  CONCLUSIONS
  Significant increases in body weight or BMI were not observed in postmenopausal women receiving CE 0.45 mg/BZA 20 mg or CE 0.625 mg/BZA 20 mg for up to 2 years in the Selective Estrogens, Menopause, and Response to Therapy trials.
authors.affiliation: 1University of Manitoba, Winnipeg, Manitoba, Canada 2Pfizer Inc, New York, NY 3Pfizer Inc, Groton, CT 4Pfizer Inc, Collegeville, PA 5Pfizer Canada Inc, Kirkland, Quebec, Canada.
authors.forename: Denise
authors.initials: D
authors.lastname: Black
authors.forename: Michael
authors.initials: M
authors.lastname: Messig
authors.forename: Ching-Ray
authors.initials: CR
authors.lastname: Yu
authors.forename: Annlouise R
authors.initials: AR
authors.lastname: Assaf
authors.forename: Barry S
authors.initials: BS
authors.lastname: Komm
authors.forename: Sebastian
authors.initials: S
authors.lastname: Mirkin
authors.forename: Matthieu
authors.initials: M
authors.lastname: Boucher
mesh_terms: D000328:Adult; D000368:Aged; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects*; D004311:Double-Blind Method; D004966:Estrogens, Conjugated (USP) / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D007211:Indoles / Q000009:adverse effects* / Q000627:therapeutic use; D008875:Middle Aged; D010919:Placebos; D017698:Postmenopause; D020845:Selective Estrogen Receptor Modulators
chemical_list: D004966:Estrogens, Conjugated (USP); D007211:Indoles; D010919:Placebos; D020845:Selective Estrogen Receptor Modulators; C447119:bazedoxifene