title: Metformin as an adjunctive treatment to control body weight and metabolic dysfunction during olanzapine administration: a multicentric, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Excessive body weight gain (BWG) is a clinically relevant side effect of olanzapine administration. The primary objective of this study was to assess whether metformin prevents or reverses BWG in patients with schizophrenia or bipolar disorder under olanzapine administration. Secondarily we evaluated diverse metabolic variables.
  
  
  METHODS
  Eighty patients taking olanzapine (5-20 mg daily for more than 4 consecutive months) were randomly allocated to metformin (n=40; 850 to 2550 mg daily) or placebo (n=40) group in a 12-week double-blind protocol. Waist circumference (WC) body weight (BW), body mass index (BMI) fasting glucose, glycated hemoglobin (Hb1c), insulin, an insulin resistance index (HOMA-IR) lipids, leptin, c-reactive protein, fibrinogen, cortisol and the growth hormone (GH) were evaluated at baseline and at week 12 of treatment.
  
  
  RESULTS
  The metformin group lost 1.4+/-3.2 kg (p=0.01) and tended to decrease its leptin levels, whereas the placebo group maintained a stable weight: -0.18+/-2.8 kg (p=0.7). The HOMA-IR significantly increased after placebo (p=0.006) and did not change after metformin (p=0.8). No ostensible differences were observed in the other variables, even though metformin did not improve the lipid profile and the Hb1c levels.
  
  
  CONCLUSIONS
  Metformin may safely assist olanzapine-treated patients in body weight and carbohydrate metabolism control.
authors.affiliation: Department of Physiology, Los Andes University Medical School, PO Box 93, Mérida, 5101-A, Venezuela. trinbap@yahoo.com
authors.forename: Trino
authors.initials: T
authors.lastname: Baptista
authors.forename: Nairy
authors.initials: N
authors.lastname: Rangel
authors.forename: Virginia
authors.initials: V
authors.lastname: Fernández
authors.forename: Edgardo
authors.initials: E
authors.lastname: Carrizo
authors.forename: Yamily
authors.initials: Y
authors.lastname: El Fakih
authors.forename: Euderruh
authors.initials: E
authors.lastname: Uzcátegui
authors.forename: Tatiana
authors.initials: T
authors.lastname: Galeazzi
authors.forename: María A
authors.initials: MA
authors.lastname: Gutiérrez
authors.forename: Mercedes
authors.initials: M
authors.lastname: Servigna
authors.forename: Adriana
authors.initials: A
authors.lastname: Dávila
authors.forename: Marycelvia
authors.initials: M
authors.lastname: Uzcátegui
authors.forename: Ana
authors.initials: A
authors.lastname: Serrano
authors.forename: Lisette
authors.initials: L
authors.lastname: Connell
authors.forename: Serge
authors.initials: S
authors.lastname: Beaulieu
authors.forename: Enma Araujo
authors.initials: EA
authors.lastname: de Baptista
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use; D001714:Bipolar Disorder / Q000097:blood / Q000188:drug therapy*; D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects*; D010054:Brief Psychiatric Rating Scale; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004734:Energy Metabolism / Q000187:drug effects; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007333:Insulin Resistance / Q000502:physiology*; D020738:Leptin / Q000097:blood; D008055:Lipids / Q000097:blood; D008297:Male; D008687:Metformin / Q000008:administration & dosage*; D008875:Middle Aged; D000077152:Olanzapine; D012559:Schizophrenia / Q000097:blood / Q000188:drug therapy*; D013223:Statistics as Topic
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D020738:Leptin; D008055:Lipids; D008687:Metformin; D000077152:Olanzapine