title: Long-term safety and tolerability of iloperidone: results from a 25-week, open-label extension trial.
abstract: OBJECTIVE
  Long-term use of the atypical antipsychotic iloperidone has not been investigated at doses above 16 mg/d. This article describes safety and tolerability results from the 25-week open-label extension of a 4-week placebo- and ziprasidone-controlled clinical trial of iloperidone.
  
  
  METHODS
  Patients received a dose of 24 mg/d (given as 12 mg twice daily; mean dose = 21.6 mg) that could be reduced to 12 mg/d (given once daily at bedtime) any time after day 35 at the investigator's discretion.
  
  
  RESULTS
  A total of 72/173 patients (41.6%) completed the open-label extension. Treatment-emergent adverse events (TEAEs), most mild to moderate in severity, included headache (13.9%), weight increase (9.2%), dizziness (6.9%), nausea (6.4%), sedation (6.4%), and insomnia (5.2%). The only notable dose-related TEAEs were increased weight and headache. Levels of serum glucose, lipids, and prolactin were essentially unchanged or decreased during treatment. In general, akathisia and extrapyramidal symptoms (EPS) improved or were unchanged during treatment. There was no signal of worsening of efficacy based on changes from baseline in the Positive and Negative Syndrome Scale-Total.
  
  
  CONCLUSIONS
  This study further supports the long-term safety and tolerability of iloperidone for the treatment of schizophrenia, including iloperidone's favorable effect on metabolic laboratory parameters and low propensity to cause akathisia or EPS.
authors: Department of Psychiatry, University of Florida, Bradenton, FL, USA. acutler@flcrc.com
authors: Andrew J
authors: AJ
authors: Cutler
authors: Amir H
authors: AH
authors: Kalali
authors: Greg W
authors: GW
authors: Mattingly
authors: Jelena
authors: J
authors: Kunovac
authors: Xiangyi
authors: X
authors: Meng
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D057915:Drug Substitution; D005260:Female; D006801:Humans; D007194:India; D007555:Isoxazoles / Q000627:therapeutic use*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000627:therapeutic use; D010880:Piperidines / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D012559:Schizophrenia / Q000188:drug therapy*; D013844:Thiazoles / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D007555:Isoxazoles; D010879:Piperazines; D010880:Piperidines; D013844:Thiazoles; C092292:ziprasidone; C081732:iloperidone