Thursday, 21 August 2003
This presentation is part of : Thursday Poster Sessions

PD-034 Pooled Analysis of the Safety and Tolerability Profile of Aripiprazole in Schizophrenia

Dusan Kostic1, Robert D. McQuade1, Anutosh R. Saha2, Stephen B. Kaplita1, Donald G. Archibald1, Taro Iwamoto3, and Elyse Stock1. (1) Bristol-Myers Squibb, Lawrenceville, NJ, USA, (2) Otsuka Maryland Research Institute, Rockville, MD, USA, (3) Otsuka Pharmaceutical Co, Tokyo, Japan

Objective: Aripiprazole is an antipsychotic with a unique pharmacologic profile combining dopamine D2 partial agonism, serotonin 5HT1A partial agonism, and 5HT2A antagonism. A pooled analysis of safety and tolerability is presented.

Design: The analysis comprises five 4- to 6-week, double-blind, multicenter studies.

Materials and Methods: The five studies included 1,648 patients hospitalized with acute relapse of schizophrenia or schizoaffective disorder. Patients were randomized to aripiprazole (n=932), placebo (n=416), or active control (haloperidol 10 mg/day [n=201] or risperidone 6 mg/day [n=99]).

Results: Aripiprazole did not produce significant dose-dependent changes in Simpson–Angus and Barnes Akathisia scores compared to placebo. Haloperidol 10 mg produced statistically significant increases vs. placebo (p<0.01). Compared to placebo, aripiprazole was associated with an increase in body weight that was similar to haloperidol and less than risperidone. Treatment with aripiprazole did not result in increases in plasma prolactin levels that were different from placebo; however, haloperidol and risperidone both increased prolactin levels. Aripiprazole was not associated with QTc prolongation. The incidence of spontaneously reported somnolence with aripiprazole was comparable to placebo.

Conclusion: The favorable safety and tolerability profile of aripiprazole, including low potential for EPS, weight gain, prolactin elevation, QTc prolongation, and somnolence, suggests that aripiprazole is an important advancement in the antipsychotic armamentarium.

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