Postmarketing surveillance of aripiprazole in a hospital-based setting

Objectives: 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 into safety and efficacy of the drug under real-life conditions. Methods: Efficacy was rated using the standard CGI, GAF, and SF-12 instruments, whereas safety was evaluated according to the spontaneous reports of adverse effects. Data from 799 patients with schizophrenia of 122 psychiatric hospitals were received for evaluation. Results: 80% of the patients were treated for 4 weeks with 10–30mg/day aripiprazole (mean modal dose 15mg/day). Within the observation period, significant improvements of CGI, GAF, and SF-12 ratings were observed. Aripiprazole was overall tolerated well by the patients. Most frequent reported adverse events were insomnia, irritability, restlessness, nausea and vomiting, in general being moderate to mild and according to the known tolerability profile of aripiprazole. Conclusion: The results demonstrate that the administration of aripiprazole may improve the symptoms of schizophrenia within 4 weeks in a real-life hospital-based in- and outpatient setting.

This study was supported by Bristol-Myers Squibb