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Meta-Analysis of the Efficacy of Aripiprazole in Schizophrenia: Presented at APA
By Bruce Sylvester
PHILADELPHIA, PA -- May 23, 2002 -- Aripiprazole improves positive and negative symptoms of schizophrenia, with significant effects appearing one week after initiation of treatment.
"The most important implication of this study is that aripiprazole 15 mg is shown to be effective in the treatment of schizophrenia. We also saw replicative efficacy in one or more studies in doses of 15 mg and above," said co-investigator William Carson, MD, group director in research and development at Bristol-Myers Squibb Research Institute in Wallingford, Connecticut. The presentation was made at the annual meeting of the American Psychiatric Association (APA).
The meta-analysis included four- to six-week multicenter, double-blind, fixed-dose, placebo-controlled studies involving a total of 1,545 patients hospitalized with acute relapse of schizophrenia or schizoaffective disorder.
The investigators randomized 898 subjects to aripiprazole, 381 to placebo, and the rest to active control: 167 to haloperidol 10 mg/day and 99 to risperidone 6 mg/day. Daily aripiprazole doses ranged from 2-30 mg.
Weekly efficacy assessments included Positive and Negative Symptoms for Schizophrenia (PANSS) and Clinical Global Impression (CGI) scales.
In the meta-analysis, aripiprazole showed superior efficacy to placebo at doses over 2 mg. The researchers also noted that aripiprazole dosing over 2 mg elicited significant improvement in PANSS-total score by week 1 (p<0.05).
In examining the individual studies, the researchers found that aripiprazole dosing at 15 mg, 20 mg and 30 mg consistently produced significant improvements in PANSS-total score. They found similar PANSS-score changes from baseline for all aripiprazole groups.
Across all of the studies, aripiprazole 15 mg, 20 mg and 30 mg produced significant improvements in other efficacy scores compared with placebo. In studies with active control, haloperidol and risperidone separated from placebo. "We had active comparator arms. Two of the active comparator drugs were haloperidol and risperidone. We saw efficacy that was comparable between aripiprazole and a typical antipsychotic, haloperidol, as well as an atypical antipsychotic, risperidone." Dr. Carson added.
The study was supported by Bristol-Myers Squibb.
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