title: Body mass index and metabolic parameters in patients with schizophrenia during long-term treatment with paliperidone palmitate.
abstract: BACKGROUND
  There is a strong association between weight gain and metabolic events in patients with schizophrenia receiving many of the second-generation antipsychotic agents. We explored the relationship between body mass index (BMI) and metabolic events in patients with schizophrenia receiving long-acting injectable paliperidone palmitate (PP) in a long-term trial.
  
  
  METHODS
  We conducted a post hoc analysis of data from a PP study that included a 33-week open-label transition (TR) and maintenance phase; a variable duration, randomized, double-blind (DB), placebo-controlled phase and a 52-week open-label extension (OLE) phase. Overall, 644 patients received PP continuously from study entry through discontinuation or study completion and were grouped by baseline BMI (kg/m2): underweight (BMI <19; n = 29, 4.5%), normal-weight (BMI 19- < 25; n = 229, 35.6%), overweight (BMI 25- < 30; n = 232, 36.0%) and obese (BMI ≥ 30; n = 154, 23.9%). Metabolic treatment-emergent adverse events (TEAEs) and changes in related laboratory results from TR baseline were analyzed.
  
  
  RESULTS
  PP exposure was similar across BMI groups; overall mean (SD) dose/month was 70.3 (17.17) mg eq. [109.6 (26.78) mg]; median duration of exposure was 204 days (6 to 1009 days). Occurrences of metabolic TEAEs overall by group were 0% (underweight), 14.9% (normal-weight), 14.7% (overweight), and 24.0% (obese). The most common (≥ 2%) metabolic TEAE were weight gain and elevated blood levels of glucose, lipids, and insulin. Mean BMI and weight increased in normal-weight and overweight groups at DB endpoint, and in underweight, normal-weight and overweight groups at OLE endpoint (p ≤ 0.05). No consistent trend for increased metabolic-related laboratory values by baseline BMI group was observed. Homeostatic model assessments for insulin resistance indicated preexisting insulin resistance at baseline, with minimal changes at OLE endpoint across baseline BMI groups.
  
  
  CONCLUSIONS
  Occurrences of metabolic-related TEAEs trended with greater BMI status in patients with schizophrenia treated with PP; consistent trends in metabolic-related laboratory values were not observed.
  
  
  BACKGROUND
  This study is registered at ClinicalTrials.gov (NCT 00518323).
authors.affiliation: Janssen Scientific Affairs, LLC, NJ, USA. jkernsli@its.jnj.com.
authors.forename: Jennifer Kern
authors.initials: JK
authors.lastname: Sliwa
authors.forename: Dong-Jing
authors.initials: DJ
authors.lastname: Fu
authors.forename: Cynthia A
authors.initials: CA
authors.lastname: Bossie
authors.forename: Ibrahim
authors.initials: I
authors.lastname: Turkoz
authors.forename: Larry
authors.initials: L
authors.lastname: Alphs
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D001786:Blood Glucose; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000097:blood / Q000139:chemically induced*; D000068882:Paliperidone Palmitate; D010168:Palmitates / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D012559:Schizophrenia / Q000097:blood / Q000188:drug therapy*; D015430:Weight Gain / Q000187:drug effects*; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D001786:Blood Glucose; D007555:Isoxazoles; D008055:Lipids; D010168:Palmitates; D000068882:Paliperidone Palmitate