Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia

Earley, Willie; Durgam, Suresh; Lu, Kaifeng; Laszlovszky, István; Debelle, M.; Kane, John M.

doi:10.1097/yic.0000000000000187

Cited by 50 publications

(37 citation statements)

References 36 publications

(39 reference statements)

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“…During the short-term and long-term studies, cariprazine treatment was not associated with serum prolactin level increases. Thyroid function changes were small and similar to placebo (25,28,31,32).…”

Section: Introductionmentioning

confidence: 73%

“…The incidence of patients with TEAEs associated with hyperglycemia and diabetes mellitus was < 1% with cariprazine and 1% with placebo. There was no clinically significant difference in the mean change from baseline to end or in shifts from normal values at baseline to high values during the study in fasting triglycerides, cholesterol or serum glucose between cariprazine and placebo-treated patients (31,32).…”

Section: Introductionmentioning

confidence: 80%

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Cariprazine Safety in Adolescents and the Elderly: Analyses of Clinical Study Data

et al. 2020

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Schizophrenia is a lifelong mental disorder, affecting young adolescents to elderly patients. Antipsychotic treatment is indicated for all patients with schizophrenia, including the very young and old as well. Developmental issues in the young and decline in organ functioning in the elderly could influence reactions to the drug, and require different dosing regimens. The aim of the present article was to examine the safety profile and dosing requirements in adolescent (13 to less than 18) and elderly (65 and above) patients treated with cariprazine. Data from two clinical studies (one pharmacokinetic pediatric study and one phase III clinical trial) on 49 adolescent patients and 17 elderly patients (65 years of age or above) treated with cariprazine was examined. Safety measures included assessment of adverse events (AEs), clinical laboratory values, physical examinations, extrapyramidal symptom (EPS)-, depression-, and suicidality rating scales. Safety parameters were summarized using descriptive statistics. Results indicate that cariprazine was generally safe and well tolerated. Adverse events in the marginal age populations were comparable to the adult population, except for less insomnia in the young and no reports of akathisia in the elderly. Laboratory parameters, vital sign values and EEG parameters were comparable to previously published data in the adult population. In conclusion, cariprazine in the approved adult dose-range of 1.5-6 mg might be a safe treatment option also in adolescent and elderly patients with schizophrenia. Further studies are need to verify these preliminary findings.

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Section: Introductionmentioning

confidence: 73%

Section: Introductionmentioning

confidence: 80%

Cariprazine Safety in Adolescents and the Elderly: Analyses of Clinical Study Data

et al. 2020

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“…10 A pooled analysis of safety and tolerability is available using three modal daily dose groups (ie, most frequent dose taken by a patient during double-blind treatment): 1.5–3, 4.5–6, and 9–12 mg/day. 24 The overall incidence of treatment-emergent adverse events vs placebo was similar for cariprazine 1.5–3 mg/day, but higher for cariprazine 4.5–6 and 9–12 mg/day, with a dose–response relationship observed for akathisia, extrapyramidal symptoms (EPS), and diastolic blood pressure. Regarding the latter, a shift from normotensive to stage I hypertension was observed in 2.0% of patients receiving placebo compared with 1.1%, 2.8%, and 6.8% for patients receiving 1.5–3, 4.5–6, and 9–12 mg/day of cariprazine, respectively.…”

Section: Efficacy and Safety In Acute Schizophreniamentioning

confidence: 95%

“…From the pooled data, mean changes in metabolic parameters were generally similar in cariprazine-treated and placebo-treated patients. 24 No prolactin level increase or QTc value >500 ms was noted. The incidence of orthostatic hypotension was similar for placebo (12.3%) and cariprazine (13.4%).…”

Section: Efficacy and Safety In Acute Schizophreniamentioning

confidence: 95%

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Cariprazine for acute and maintenance treatment of adults with schizophrenia: an evidence-based review and place in therapy

Citrome¹

2018

NDT

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Cariprazine is an oral antipsychotic approved in the US and EU for the treatment of schizophrenia. Cariprazine differs from other antipsychotics in that it is a dopamine D3- and D2-receptor partial agonist, with tenfold higher affinity for D3 receptors than for D2 receptors. Cariprazine is metabolized in two steps by CYP3A4 to didesmethyl-cariprazine (DDCAR). DDCAR has a long half-life of 1–3 weeks and is the predominant circulating active moiety. Efficacy and safety in persons with acute schizophrenia were assessed in four similarly designed, short-term, randomized, placebo-controlled clinical trials in nonelderly adults, with three studies considered positive and yielding a number needed to treat vs placebo for response (change from baseline ≥30% in Positive and Negative Syndrome Scale total score) of ten for the approved dose range of cariprazine 1.5–6 mg/day. The most common adverse reactions were extrapyramidal symptoms (15% and 19% for 1.5–3 and 4.5–6 mg/day, respectively, vs 8% for placebo) and akathisia (9% and 12.5% for 1.5–3 and 4.5–6 mg/day, respectively, vs 4% for placebo). For the approved dose range, rates of discontinuation because of an adverse event were lower overall for patients receiving cariprazine vs placebo (9% vs 12%). Weight and metabolic profile appear favorable. Cariprazine does not increase prolactin levels or prolong the electrocardiographic QT interval. Cariprazine has also been found to be effective for the maintenance treatment of schizophrenia by delaying time to relapse when compared with placebo (HR 0.45). A 26-week randomized clinical trial evidenced superiority of cariprazine over risperidone for the treatment of predominantly negative symptoms in patients with schizophrenia. Cariprazine is also approved in the US for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and is being studied for the treatment of bipolar I depression and major depressive disorder.

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A case series of serious and unexpected adverse drug reactions under treatment with cariprazine

Heck

Seifert

Stichtenoth

et al. 2021

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Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia

Abstract: Supplemental Digital Content is available in the text.

Cited by 50 publications

References 36 publications

Cariprazine Safety in Adolescents and the Elderly: Analyses of Clinical Study Data

Cariprazine Safety in Adolescents and the Elderly: Analyses of Clinical Study Data

Cariprazine for acute and maintenance treatment of adults with schizophrenia: an evidence-based review and place in therapy

A case series of serious and unexpected adverse drug reactions under treatment with cariprazine

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