Brexpiprazole in patients with schizophrenia: overview of short- and long-term phase 3 controlled studies

Autor: Catherine Weiss, Mette Krog Josiassen, Emmanuelle Weiller, Mika Juhani Hakala, John Ouyang, Mary Hobart, Stephen R. Marder, Peter Zhang
Rok vydání: 2016
Předmět:
Zdroj: Acta Neuropsychiatrica. 29:278-290
ISSN: 1601-5215
0924-2708
DOI: 10.1017/neu.2016.57
Popis: ObjectiveReview efficacy, safety, and tolerability of brexpiprazole in patients with schizophrenia in short- and long-term phase 3 studies.MethodsPatients experiencing a current exacerbation of schizophrenia received brexpiprazole in two fixed-dose (2 and 4 mg), 6-week, placebo-controlled studies, one flexible-dose (2–4 mg), 6-week, placebo-control and active reference study, and one fixed-dose (1–4 mg), 52-week, placebo-controlled maintenance study.ResultsThe efficacy of brexpiprazole was demonstrated in the two short-term fixed-dose studies with statistically significant improvements from baseline in Positive and Negative Syndrome Scale (PANSS) total score compared with placebo. In the flexible-dose short-term study, treatment with brexpiprazole resulted in numerically greater improvements in PANSS total score than with placebo that approached statistical significance (p=0.056). A meta-analysis of these short-term studies showed a mean change in PANSS total score of −20.1, reflecting a clinically meaningful reduction in symptoms. In the maintenance study, brexpiprazole had a beneficial effect relative to placebo on time to exacerbation of psychotic symptoms/impending relapse (pConclusionsOverall, the results indicate brexpiprazole, used either short-term or as part of a long-term maintenance treatment programme, is an efficacious therapy option in adults with schizophrenia and has a favourable safety/tolerability profile.
Databáze: OpenAIRE