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Aripiprazole Safety Similar in Patients of Various Races: Presented at APA

By Paula Moyer

SAN FRANCISCO, CA -- May 23, 2003 -- Patients from diverse ethnic and racial backgrounds tolerate aripiprazole (Abilify) similarly well and have similar rates of adverse effects from treatment.

This finding is important, because previous research showed some psychotropic medications are metabolized at different rates by people of different ethnic groups, according to Shirley C. Lam, PharmD, co-investigator of a recent study. Therefore, certain patients can have a higher risk of adverse effects from those medications.

The study results were presented here May 21^st at the 2003 Annual Meeting of the American Psychiatric Association.

"Aripiprazole is metabolized by more than one cytochrome P450 [CYP450] isoenzyme," said co-investigator Robert McQuade, PhD. "Both CYP 2D6 and CYP 3A4 are involved in the metabolism of this medication." Thus, the risk of adverse effects from slow metabolism are minimized, he said.

Previous studies showed that African-Americans in particular were at greater risk of adverse events -- particularly extrapyramidal symptoms and tardive dyskinesia -- from antipsychotic agents.

To determine the safety and tolerability profile of aripiprazole in patients with different racial backgrounds, the researchers pooled and analyzed data from several short-term placebo-controlled studies of aripiprazole for treatment of schizophrenia or schizoaffective disorder.

The database involved 1,339 patients, of whom 715 were white, 427 were black, 135 were Hispanic, and 31 were Asian. The remaining 31 were classified as "other." The investigators assessed patients' response to treatment by race using the Positive and Negative Syndrome Scale (PANSS) for schizophrenia. They also assessed the incidence of the following adverse events by race: extrapyramidal symptoms, akathisia, tremor, somnolence, insomnia, nausea, and vomiting.

Results show that aripiprazole's safety and tolerability profile in the various patient subgroups was similar to that in the total patient population. They found the incidence of adverse events to be generally low and similar to that seen with placebo in each racial group.

Extrapyramidal symptoms were experienced by 9.2% of black patients, compared with 4.5% of white patients (P=.264). However, several related adverse events, such as tremor and hypertonia, were reported less frequently in black patients than in white patients. All patients had similar rates of somnolence, insomnia, nausea, and vomiting.

The decreases in PANSS scores were similar across racial lines as well. The investigators also found that patients' plasma concentrations of aripiprazole were similar across all racial categories.

Bristol-Myers Squibb Company, the manufacturers of Abilify, supported the study.


[Study title: Safety of aripiprazole in patients with schizophrenia grouped by race. Abstract NR577]

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