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Pharmacopsychiatry 2009; 42(3): 101-108
DOI: 10.1055/s-0028-1112129
Original Paper

© Georg Thieme Verlag KG Stuttgart · New York

Psychosocial Functioning in Patients with Schizophrenia Treated with Aripiprazole – an Office-based Real-world Setting. Results from the German Post-marketing Surveillance Study

F. Bergmann 1 , A. Zacher 2 , A. Nass 3 , R. Urban 4 , C. Werner 5 , T. Spevakné-Göröcs 6 , M. Kungel 6 , M. Ebrecht 6 , S. Modell 6
  • 1Medical Practice, Aachen, Germany
  • 2Medical Practice, Regensburg, Germany
  • 3Medical Practice, Cologne, Germany
  • 4Medical Practice, Berlin, Germany
  • 5Otsuka Pharma GmbH, Frankfurt, Germany
  • 6Bristol-Myers Squibb GmbH, Munich, Germany
Further Information

Publication History

received 08.11.2007 revised 20.10.2008

accepted 29.10.2008

Publication Date:
18 May 2009 (online)

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Abstract

Aim: Aripiprazole (ABILIFY®) is an effective antipsychotic used in a dose range from 10 to 30 mg, administered once daily. Soon after its approval in Germany for treatment of schizophrenia, a 12-month post-marketing surveillance study was initiated that included 1 096 patients cared for by 408 office-based psychiatrists and/or neurologists in private practice. The aim was to gain further insights into safety and efficacy of aripiprazole in an outpatient real-life setting focusing on general health, well-being and psychosocial functioning.

Patients and Methods: Efficacy was rated by using standard CGI, SF-12® and SIWM-PsySo® instruments for severity of disease, physical and mental health outcomes and psychosocial state, respectively. Safety was evaluated according to the reports of adverse events. Mean total daily dose of aripiprazole increased from 15.4 mg at the visit after 1 month to 17.6 mg at the visits after 6 to 12 months, the most frequently administered maintenance dose being 15 mg.

Results and Discussion: Within the observation period significant improvements of CGI, SF-12® and SIWM-PsySo® scores over time versus baseline values were observed (p<0.001) when starting with or switching to aripiprazole. Physicians observed improvements in 80.7% of the patients at endpoint; in 62% of the patients the disease state was considered “much” or “very much” improved. Aripiprazole was overall well tolerated; 19.9% of patients discontinued treatment after 12 months. Adverse effects in general were moderate to mild and corresponded to the known tolerability profile of aripiprazole. Psychotic side effects reported were probably due to a recurrence of the underlying schizophrenic disorder.

Conclusion: The results indicate that aripiprazole may be an efficacious and safe treatment option for pre-treated patients with schizophrenia also in a naturalistic psychiatrist/neurologist practice setting with effects on health and psychosocial functioning and a comparably low dropout rate.

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Correspondence

Dr. S. Modell

Neuroscience/Immunoscience

Bristol-Myers Squibb GmbH & Co. KGaA

Munich

Germany

Phone: +49/89/121 42 203

Fax: +49/89/121 42 301

Email: sieglinde.modell@bms.com

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