title: Safety and efficacy of olanzapine in the long-term treatment of Japanese patients with bipolar I disorder, depression: an integrated analysis.
abstract: OBJECTIVE
  Safety and efficacy of long-term olanzapine treatment in Japanese patients with bipolar depression were assessed.
  
  
  METHODS
  An integrated analysis of data from two studies was performed in olanzapine-treated patients (n = 165) with bipolar depression. Study 1 was a 6-week, double-blind, global study. Patients were randomly assigned to olanzapine or placebo followed by 18 weeks of open-label treatment. Study 2 was an open-label extension of Study 1 involving only Japanese patients. Patients assigned to Pre-olanzapine and Pre-placebo in Study 1 were treated for 24 weeks (total olanzapine exposure 42 or 48 weeks) and newly recruited patients (New-olanzapine) were treated for 48 weeks. Safety outcomes included treatment-emergent adverse events and changes in metabolic parameters. Efficacy outcome was assessed with Montgomery-Åsberg Depression Rating Scale score.
  
  
  RESULTS
  Forty-three percent of patients completed the 42- or 48-week olanzapine treatment period. The most common treatment-emergent adverse event was weight increased (47.9%). Significant increases were seen in weight (3.5 kg), and in fasting glucose (3.5 mg/dL), fasting total cholesterol (8.1 mg/dL), and fasting triglycerides (35.1 mg/dL). Remission rates (Montgomery-Åsberg Depression Rating Scale total score ≤12 at any time) were 79.8% for the Pre-olanzapine group, 90.2% for the Pre-placebo group, and 85.0% for the New-olanzapine group. No patents developed mania during treatment.
  
  
  CONCLUSIONS
  Long-term use of olanzapine in a Japanese population with bipolar depression is associated with increases in weight and fasting metabolic measures, and also with improved depressive symptoms with avoidance of mania. Clinicians must carefully consider the benefits and risks of long-term therapy with olanzapine.
authors.affiliation: Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Katagiri
authors.forename: Mauricio
authors.initials: M
authors.lastname: Tohen
authors.forename: David P
authors.initials: DP
authors.lastname: McDonnell
authors.forename: Shinji
authors.initials: S
authors.lastname: Fujikoshi
authors.forename: Michael
authors.initials: M
authors.lastname: Case
authors.forename: Shigenobu
authors.initials: S
authors.lastname: Kanba
authors.forename: Michihiro
authors.initials: M
authors.lastname: Takahashi
authors.forename: Juan-Carlos
authors.initials: JC
authors.lastname: Gomez
mesh_terms: D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D000077152:Olanzapine; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D000077152:Olanzapine; D017367:Selective Serotonin Reuptake Inhibitors
keywords: Japanese; bipolar depression; long-term efficacy; long-term safety; olanzapine monotherapy