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| |  CINP: Aripiprazole Delays Relapse in Patients with Chronic Schizophrenia By Heather Pengelley Special to DG News MONTREAL, QC -- June 28, 2002 -- Aripiprazole, a partial dopamine agonist, delays time to relapse and improves symptoms in patients with chronic but stable schizophrenia. These findings, from a double-blind, placebo-controlled trial, were presented here June 27th at the 23rd Congress of the Collegium Internationale Neuro-Psychopharmacologicum (CINP). Researchers led by W. I. L. Crison, of Bristol-Myers Squibb, in Wallingford, Connecticut, United States, enrolled 310 patients with chronic but stable schizophrenia in the United States, Russia, the Ukraine, Poland, and the Czech Republic. Patients were randomly assigned to treatment with 15 mg/d of aripiprazole or placebo for 26 weeks. Baseline characteristics of patients in both groups were similar. The investigators measured time to relapse since randomization as well as scores on the Positive and Negative Syndrome Scale (PANSS). "Aripiprazole was effective in relapse prevention," said Dr. Mary Kujawa, Medical Director, New Drug Development, Bristol-Myers Squibb Co., in Princeton, New Jersey, on behalf of the investigators. "With aripiprazole, there is minimal weight gain, minimal EPS [extrapyramidal symptoms], no elevation of prolactin level, no prolongation of QTc interval. Overall, it’s a very favorable package." During the trial, the number of relapses was significantly lower in the aripiprazole group compared to the placebo group (34 versus 57 percent, p<0.001). At 26 weeks, the likelihood of not having a relapse was 39 percent in the placebo group and 63 percent in aripiprazole-treated patients. Aripiprazole therapy also had a significantly beneficial effect on total PANSS scores and PANSS Positive Subscale Score compared to placebo (p=0.05). Negative symptoms remained stable in both study groups. Rates of nausea, vomiting, akathisia, insomnia, and tremor were all higher in the in aripiprazole-treated patients compared to the placebo group, but no aripiprazole-related adverse events occurred even as much as 10 percent more frequently compared to placebo. No patients attempted suicide during the study, and no cases of tardive dyskinesia were reported. There were no differences between the two groups with respect to weight gain or EPS. According to investigators, aripiprazole did not increase somnolence. This long-term, favorable safety profile may lead to better compliance and quality of life in patients with chronic schizophrenia, the investigators concluded.
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