BMS/Otsuka schizophrenia drug beats rivals in study

The data are from a study called STAR, which was performed in community-based treatment settings, evaluating more than 500 adults with schizophrenia. In the study, aripiprazole demonstrated significantly greater improvement on the investigator’s assessment questionnaire (IAQ) versus standard of care.

The IAQ is a validated instrument that is a combined measure of efficacy, safety and tolerability. Standard-of-care included treatment with either olanzapine, quetiapine or risperidone.

In the STAR Trial, 555 adults with schizophrenia whose clinical symptoms were not optimally controlled or who experienced tolerability problems with their current medication were randomized to either aripiprazole (10-30mg/day) or one of the three standard of care therapies. The choice of standard of care was based on physician discretion; the results from subjects on a standard of care therapy were analyzed and reported as one group.

Study results revealed that, at week 26, the mean IAQ total score was significantly lower for adults taking aripiprazole compared with standard of care: 25.7 vs. 27.7, respectively. Similar results were reported for the mean change in clinical global impression improvement (CGI-I) score.

The findings, which were presented at the 159th annual meeting of the American Psychiatric Association (APA), also reported the effects of aripiprazole and standard of care on changes in metabolic measures, including weight and blood lipids, and change in sexual dysfunction.