title: A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d.
abstract: OBJECTIVE
  To assess the effect of baseline body mass index (BMI) on efficacy and weight change in adults with major depressive disorder (MDD) treated with desvenlafaxine or placebo in a pooled, post hoc analysis.
  
  
  METHODS
  Adults with MDD were randomly assigned to placebo or desvenlafaxine (50 mg or 100 mg) in 8 short-term, double-blind studies and 1 longer-term randomized withdrawal study (the studies were published between 2007 and 2013). Change from baseline in 17-item Hamilton Depression Rating Scale (HDRS-17) total score at week 8 was analyzed in normal (BMI ≤ 25 kg/m(2)), overweight (25 kg/m(2) < BMI ≤ 30 kg/m(2)), and obese (BMI > 30 kg/m(2)) subgroups using analysis of covariance (ANCOVA). Weight change was analyzed in BMI subgroups using ANCOVA and a mixed-effects model for repeated measures.
  
  
  RESULTS
  Desvenlafaxine 50 mg/d or 100 mg/d improved HDRS-17 scores significantly from baseline to week 8 (last observation carried forward) versus placebo in all BMI subgroups (normal: n = 1,122; overweight: n = 960; obese: n = 1,302; all P ≤ .0027); improvement was greatest in normal BMI patients. There was a statistically significant decrease in weight (< 1 kg) with short-term desvenlafaxine 50 mg/d and 100 mg/d versus placebo in all BMI subgroups (all P < .0001). In the randomized withdrawal study (n = 548), no statistically significant difference in weight was observed for desvenlafaxine versus placebo in any BMI subgroup. Baseline BMI predicted weight change in short-term and longer-term desvenlafaxine treatment.
  
  
  CONCLUSIONS
  Desvenlafaxine significantly improved symptoms of depression versus placebo regardless of baseline BMI. In all BMI subgroups, desvenlafaxine was associated with statistically significant weight loss (< 1 kg) versus placebo over 8 weeks, but no significant differences longer term.
  
  
  BACKGROUND
  ClinicalTrials.gov identifiers: NCT00072774, NCT00277823, NCT00300378, NCT00384033, NCT00798707, NCT00863798, NCT01121484, NCT00824291, NCT00887224.
authors.affiliation: Department of Psychiatry and Pharmacology, University of Toronto and Mood Disorders Psychopharmacology Unit, University Health Network,Toronto, Ontario, Canada (Dr McIntyre); Pfizer Inc, New York, New York (Dr Fayyad); Pfizer Inc, Collegeville, PA (Dr Guico-Pabia); and Pfizer Canada Inc, Kirkland, Quebec (Dr Boucher). Dr Guico-Pabia is now with CGP Strategic Solutions, LLC, Lansdale, Pennsylvania.
authors.forename: Roger S
authors.initials: RS
authors.lastname: McIntyre
authors.affiliation: Department of Psychiatry and Pharmacology, University of Toronto and Mood Disorders Psychopharmacology Unit, University Health Network,Toronto, Ontario, Canada (Dr McIntyre); Pfizer Inc, New York, New York (Dr Fayyad); Pfizer Inc, Collegeville, PA (Dr Guico-Pabia); and Pfizer Canada Inc, Kirkland, Quebec (Dr Boucher). Dr Guico-Pabia is now with CGP Strategic Solutions, LLC, Lansdale, Pennsylvania.
authors.forename: Rana S
authors.initials: RS
authors.lastname: Fayyad
authors.affiliation: Department of Psychiatry and Pharmacology, University of Toronto and Mood Disorders Psychopharmacology Unit, University Health Network,Toronto, Ontario, Canada (Dr McIntyre); Pfizer Inc, New York, New York (Dr Fayyad); Pfizer Inc, Collegeville, PA (Dr Guico-Pabia); and Pfizer Canada Inc, Kirkland, Quebec (Dr Boucher). Dr Guico-Pabia is now with CGP Strategic Solutions, LLC, Lansdale, Pennsylvania.
authors.forename: Christine J
authors.initials: CJ
authors.lastname: Guico-Pabia
authors.affiliation: Department of Psychiatry and Pharmacology, University of Toronto and Mood Disorders Psychopharmacology Unit, University Health Network,Toronto, Ontario, Canada (Dr McIntyre); Pfizer Inc, New York, New York (Dr Fayyad); Pfizer Inc, Collegeville, PA (Dr Guico-Pabia); and Pfizer Canada Inc, Kirkland, Quebec (Dr Boucher). Dr Guico-Pabia is now with CGP Strategic Solutions, LLC, Lansdale, Pennsylvania.
authors.forename: Matthieu
authors.initials: M
authors.lastname: Boucher