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Safety and tolerability of cariprazine in patients with schizophrenia: A pooled analysis of eight phase II/III studies

Neuropsychiatric Disease and Treatment Apr 11, 2021

Barabássy Á, Sebe B, Acsai K, et al. - Researchers performed post hoc analyses to describe the safety profile of cariprazine, a potent dopamine D3/D2 receptor partial agonist approved for treating adults with schizophrenia and acute manic/mixed and depressive episodes linked with bipolar I disorder (US), within the recommended 1.5– 6 mg/d dose range. They analyzed data from eight short- or long-term clinical trials. The rate of study completion was 52.8% in the pooled cariprazine-treated safety population (n = 2,048); the most common reasons for premature discontinuation were withdrawal of consent, insufficient response, and AEs. The most common cariprazine-related AE was akathisia, which was mild/moderate and led to few study discontinuations; symptoms were well managed and most patients remained on treatment. Per results of this analysis, cariprazine in the recommended dose range was suggested to be safe and generally well tolerated in patients with schizophrenia.

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