The efficacy and safety of cariprazine in the early and late stage of schizophrenia: a post hoc analysis of three randomized, placebo-controlled trials.

Abstract

BACKGROUND:

The aim of the post hoc analysis was to better understand the efficacy and safety of cariprazine in patients with schizophrenia for less than 5 years (early stage) and for more than 15 years (late stage).

METHODS:

Data from three phase II/III randomized, double-blind, placebo-controlled trials with similar design in patients with acute exacerbation of schizophrenia were pooled and patients with early and late stage of schizophrenia were determined. A mixed-effects model for repeated measures approach was applied and least square (LS) mean changes from baseline to week 6 on the Positive and Negative Syndrome Scale (PANSS) total and factor scores were reported. Descriptive statistics were used for safety analyses including treatment emergent adverse events (TEAEs) and discontinuation rates.

RESULTS:

Overall, 460 patients were identified as being in the early and 414 in the late stage of schizophrenia. The pooled analysis evaluating mean change from baseline to week 6 in the PANSS total score indicated statistically significant difference between cariprazine and placebo in favor of cariprazine in both the early (LS mean difference [LSMD] -7.5 P < .001) and late stage (LSMD -6.7, P < .01) subpopulation. Early stage patients experienced similar amount of TEAEs (CAR 67.3%, PBO 54.1%) as patients in the late stage (CAR 69.6%, PBO 65.6%).

CONCLUSION:

In conclusion, cariprazine, a potent D3-D2 partial agonist has been found to be safe and effective in the treatment of early and late stage schizophrenia.

• Authors: Peter Falkai, Zsófia B Dombi, Károly Acsai, Ágota Barabássy, Andrea Schmitt, György Németh
• Journal: CNS spectrums (CNS Spectr) Vol. 28 Issue 1 Pg. 104-111 (02 2023) ISSN: 1092-8529 [Print] United States
• PMID: 35012696 (Publication Type: Randomized Controlled Trial, Journal Article)

Chemical References

• cariprazine
• Antipsychotic Agents
• Piperazines

Topics

• Humans
• Schizophrenia (drug therapy)
• Antipsychotic Agents (adverse effects)
• Treatment Outcome
• Piperazines (adverse effects)
• Double-Blind Method