Cardiac safety with cariprazine treatment.

Introduction: Long-term treatment with antipsychotic agents is indicated for all patients with schizophrenia. Antipsychotic drugs can be of great benefit for a range of symptoms, but treatment is associated with unpleasant side effects. Prolongation of the QT interval among other cardiac safety aspects is a concern for clinicians managing psychiatric drug regimens, as it can lead to serious conditions or even result in death. Objectives: The objective of this analysis is to evaluate the effects of cariprazine on cardiac safety parameters in comparison to placebo. Methods: Data from eight schizophrenia studies (including 4 short-term 6-week, 1 long-term 26-week, 2 long-term 48-week and 1 long-term up to 92-week studies), were analyzed. Heart rate, QT interval changes, adverse events and discontinuation rates due to cardiac parameters were examined. Data was analyzed for placebo and cariprazine groups. Safety parameters were summarized using descriptive statistics. Results: A slight increase from baseline in ventricular heart rate (~2bpm) was observed with cariprazine treatment, which was comparable to placebo treatment (~1bpm). QT prolongation was observed in ~1% of cariprazine patients vs ~1% of placebo patients. The percentage of patients with TEAEs associated with changes on ECGwas ~2%in both groups. Discontinuation due to cardiac TEAEs was low: 0.3% with cariprazine vs. 0.1% with placebo treatments. Conclusions: Change in cardiac safety parameters was comparable for cariprazine and placebo treatments. Cariprazine did not significantly increase QT. [ABSTRACT FROM AUTHOR]