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

Acta neuropsychiatrica, 2017-10, Vol.29 (5), p.278-290 [Peer Reviewed Journal]

Scandinavian College of Neuropsychopharmacology 2016 ;ISSN: 0924-2708 ;EISSN: 1601-5215 ;DOI: 10.1017/neu.2016.57 ;PMID: 27846922

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  • Title:
    Brexpiprazole in patients with schizophrenia: overview of short- and long-term phase 3 controlled studies
  • Author: Marder, Stephen R. ; Hakala, Mika Juhani ; Josiassen, Mette Krog ; Zhang, Peter ; Ouyang, John ; Weiller, Emmanuelle ; Weiss, Catherine ; Hobart, Mary
  • Subjects: Adult ; Anesthesia ; Antipsychotic Agents - therapeutic use ; Antipsychotics ; Dopamine ; Double-Blind Method ; Drug dosages ; Female ; Humans ; Male ; Middle Aged ; Original Articles ; Patients ; Psychosis ; Psychotropic drugs ; Quality of life ; Quinolones - therapeutic use ; Regulatory approval ; Schizophrenia ; Schizophrenia - drug therapy ; Serotonin ; Thiophenes - therapeutic use ; Treatment Outcome
  • Is Part Of: Acta neuropsychiatrica, 2017-10, Vol.29 (5), p.278-290
  • Description: Review efficacy, safety, and tolerability of brexpiprazole in patients with schizophrenia in short- and long-term phase 3 studies. Patients 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. The 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 (p<0.0001). For all studies, brexpiprazole demonstrated clinically meaningful treatment effects on the Personal and Social Performance scale. Brexpiprazole had a favourable safety profile, with a relatively low prevalence of activating and sedating side effects. Weight gain in the short-term studies was ~1 kg greater than placebo. No safety concerns were observed with brexpiprazole in laboratory values, electrocardiogram, or vital signs. Overall, 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.
  • Publisher: Cambridge, UK: Cambridge University Press
  • Language: English;Dutch
  • Identifier: ISSN: 0924-2708
    EISSN: 1601-5215
    DOI: 10.1017/neu.2016.57
    PMID: 27846922
  • Source: ProQuest One Psychology
    AUTh Library subscriptions: ProQuest Central
    MEDLINE
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