Clinical use of aripiprazole in patients with schizophrenia: a real-life setting results from the German Postmarketing Surveillance Study

World J Biol Psychiatry. 2010 Mar;11(2 Pt 2):231-8. doi: 10.1080/15622970701429854.

Abstract

When aripiprazole (ABILIFY) received its approval in Germany for the treatment of schizophrenia, a hospital-based postmarketing surveillance study was initiated in order to gain further insights concerning safety and efficacy of the antipsychotic under real-life conditions. Efficacy was rated by using standard CGI, GAF, and SF-12 instruments, whereas safety was evaluated according to the reports on adverse effects. Data from 799 patients with schizophrenia from 122 psychiatric hospitals returned for evaluation. Eighty percent of the patients were treated for 4 weeks with 10-30 mg/day aripiprazole (mean modal dose 15 mg/day). Within the observation period significant improvements of CGI, GAF, and SF-12 ratings was observed. Aripiprazole was tolerated well by the patients. Most frequent adverse effects were insomnia, irritability, restlessness, nausea and vomiting, in general being moderate to mild and corresponding to the known tolerability profile of aripiprazole. The results demonstrate that the administration of aripiprazole can result in an improvement of the symptoms of schizophrenia within 4 weeks in a real-life hospital-based in- and outpatient setting.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Akathisia, Drug-Induced / etiology
  • Antipsychotic Agents / adverse effects
  • Antipsychotic Agents / therapeutic use*
  • Aripiprazole
  • Female
  • Germany
  • Humans
  • Male
  • Nausea / chemically induced
  • Piperazines / adverse effects
  • Piperazines / therapeutic use*
  • Product Surveillance, Postmarketing*
  • Prospective Studies
  • Psychiatric Status Rating Scales
  • Quinolones / adverse effects
  • Quinolones / therapeutic use*
  • Schizophrenia / drug therapy*
  • Sleep Initiation and Maintenance Disorders / chemically induced
  • Vomiting / chemically induced

Substances

  • Antipsychotic Agents
  • Piperazines
  • Quinolones
  • Aripiprazole