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

Overview of attention for article published in BMC Psychiatry, August 2017
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Title
The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis
Published in
BMC Psychiatry, August 2017
DOI 10.1186/s12888-017-1459-z
Pubmed ID
Authors

Henry A. Nasrallah, Willie Earley, Andrew J. Cutler, Yao Wang, Kaifeng Lu, István Laszlovszky, György Németh, Suresh Durgam

Abstract

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. 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). 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. 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. NCT01104792, NCT00839852.

Twitter Demographics

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Mendeley readers

The data shown below were compiled from readership statistics for 52 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 52 100%

Demographic breakdown

Readers by professional status Count As %
Student > Postgraduate 7 13%
Student > Master 6 12%
Student > Ph. D. Student 6 12%
Student > Bachelor 5 10%
Researcher 5 10%
Other 12 23%
Unknown 11 21%
Readers by discipline Count As %
Medicine and Dentistry 21 40%
Psychology 7 13%
Neuroscience 4 8%
Engineering 2 4%
Social Sciences 2 4%
Other 2 4%
Unknown 14 27%

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 25 August 2017.
All research outputs
#11,040,235
of 14,537,474 outputs
Outputs from BMC Psychiatry
#2,585
of 3,401 outputs
Outputs of similar age
#183,276
of 269,554 outputs
Outputs of similar age from BMC Psychiatry
#1
of 1 outputs
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