Abstract
BackgroundSchizophrenia 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.MethodsTo 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).ResultsOf 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.ConclusionIn 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 registrationNCT01104792, NCT00839852.
Highlights
Schizophrenia is a chronic and debilitating neuropsychiatric disorder that often requires long-term pharmacotherapy to manage symptoms and prevent relapse
Completion rates were higher in the 1.5–3 and 4.5–6 mg/d modal daily dose groups than in the 9 mg/d modal daily dose group (Table 1)
The most frequent reason for discontinuation in any group was withdrawal of consent, which occurred at a similar incidence across doses; discontinuation due to Adverse event (AE) was highest in the 9 mg/d and 1.5–3 mg/d dose groups
Summary
Schizophrenia is a chronic and debilitating neuropsychiatric disorder that often requires long-term pharmacotherapy to manage symptoms and prevent relapse. Schizophrenia is a chronic and debilitating neuropsychiatric disorder with high rates of medical morbidity and mortality [1]. To manage symptoms and prevent relapse, long-term pharmacotherapy is often required [2]. Only small differences in efficacy have been observed among antipsychotic agents in clinical trials, there is variability in individual patient response, as well as in the side effect and tolerability profiles [3]. These factors warrant careful consideration when choosing an antipsychotic treatment
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