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BMC Psychiatry. 2017 Aug 24;17(1):305. doi: 10.1186/s12888-017-1459-z.

The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis.

Author information

1
Saint Louis University, 1438 South Grand Blvd., Suite 105, St. Louis, MO, 63104, USA. hnasral@slu.edu.
2
Allergan, Harborside 5, 185 Hudson Street, Jersey City, NJ, 07311, USA.
3
Meridien Research, Inc., 8043 Cooper Creek Boulevard #107, Bradenton, FL, 34201, USA.
4
Gedeon Richter, Plc, Gyömrői u. 32, Budapest, H-1103, Hungary.

Abstract

BACKGROUND:

Schizophrenia is a chronic and debilitating neuropsychiatric disorder that often requires long-term pharmacotherapy to manage symptoms and prevent relapse. Cariprazine is a potent dopamine D3 and D2 receptor partial agonist that is FDA-approved in the US for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults; the recommended dose range is 1.5-6 mg/d.

METHODS:

To further characterize the long-term safety of cariprazine, data from two 48-week open-label, flexible-dose extension studies were pooled for post hoc analyses. Outcomes were evaluated in the pooled safety population (patients who received ≥1 dose of cariprazine during an open-label extension period); findings were summarized using descriptive statistics for the overall cariprazine group and in modal daily dose groups (1.5-3, 4.5-6, and 9 mg/d).

RESULTS:

Of the 679 patients in the overall cariprazine safety population, 40.1% completed the study. The only adverse events (AEs) leading to discontinuation of ≥2% of patients in any dose group were akathisia, worsening of schizophrenia, and psychotic disorder. Treatment-emergent AEs (TEAEs) of akathisia, insomnia, weight increased, and headache were reported in ≥10% of the overall population. Mean prolactin levels decreased in all dose groups (overall, -15.4 ng/mL). Clinically insignificant changes in aminotransferase levels and alkaline phosphatase were observed; no dose-response relationship was observed across groups. Mean total (-5.3 mg/dL), low-density lipoprotein (-3.5 mg/dL), and high-density lipoprotein (-0.8 mg/dL) cholesterol levels decreased; no dose-response relationship was observed for metabolic parameters. Mean change in body weight was 1.58 kg; body weight increase and decrease ≥7% occurred in 27% and 11% of patients, respectively. Mean changes in cardiovascular parameters, including blood pressure and pulse, were generally not considered clinically significant. EPS-related TEAEs that occurred in ≥5% of patients were akathisia, tremor, restlessness, and extrapyramidal disorder.

CONCLUSION:

In these post hoc pooled analyses of data from 2 long-term open-label studies, treatment with cariprazine was generally safe and well tolerated. Results support the safety and tolerability of cariprazine within the FDA-recommended dose range of 1.5-6 mg/d for schizophrenia.

CLINICAL TRIALS REGISTRATION:

NCT01104792, NCT00839852.

KEYWORDS:

Atypical antipsychotic; Cariprazine; Long-term safety; Open-label; Post hoc analysis; Schizophrenia

PMID:
28836957
PMCID:
PMC5571492
DOI:
10.1186/s12888-017-1459-z
[Indexed for MEDLINE]
Free PMC Article

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