Global improvement with cariprazine in the treatment of bipolar I disorder and schizophrenia: A pooled post hoc analysis

• Published in: International journal of clinical practice (Esher) Vol. 71; no. 12; pp. e13037 - n/a
• Main Authors: Durgam, Suresh, Earley, Willie, Lu, Kaifeng, Németh, György, Laszlovszky, István, Volk, Stephen, Litman, Robert E.
• Format: Journal Article
• Language: English
• Published: England Hindawi Limited 01.12.2017; John Wiley and Sons Inc
• Subjects: Affective disorders; Antipsychotic Agents - therapeutic use; Antipsychotics; Bipolar disorder; Bipolar Disorder - drug therapy; Clinical trials; Dopamine D2 receptors; Dopamine D3 receptors; Humans; Mental disorders; Original Paper; Piperazines - therapeutic use; Psychiatry; Psychopharmacology; Schizophrenia; Schizophrenia - drug therapy; Severity of Illness Index; Statistical analysis
• ISSN: 1368-5031; 1742-1241
• DOI: 10.1111/ijcp.13037

Summary Introduction Global rating scale measures are useful for assessing the clinical relevance of patient change. Cariprazine, a dopamine D3 and D2 receptor partial agonist, is FDA‐approved for the adult treatment of acute manic/mixed episodes of bipolar I disorder and schizophrenia. Post hoc evaluations of Clinical Global Impressions‐Severity (CGI‐S) scores from the cariprazine pivotal trials in both indications were conducted. Methods Data from 3 bipolar mania and 3 schizophrenia trials were pooled by indication (bipolar disorder = 1033; schizophrenia = 1466). Cariprazine‐ and placebo‐treated patients were categorised by baseline CGI‐S scores; the proportion of patients who improved from more severe categories at baseline to less severe categories at end‐point was evaluated using a logistic regression model. Correlations between Young Mania Rating Scale and Positive and Negative Syndrome Scale total score changes and category shifts were also evaluated. Results In both disease states, more cariprazine‐ than placebo‐treated patients had improved CGI‐S scores at end‐point; more placebo‐treated patients had worse end‐point scores. More cariprazine‐ vs placebo‐treated patients shifted from the extremely/severely ill to mildly ill/better category (bipolar disorder = 55% vs 36%, odds ratio [OR] = 2.1; P = .09; schizophrenia = 42% vs 18%, OR = 3.4, P<.01). ORs was statistically significant in favour of cariprazine in shifts from marked and moderate illness to borderline/normal in both indications (P < .05). Correlations between rating scale improvement and category shift were greatest in patients with extreme/severe baseline illness for bipolar disorder (−0.853) and schizophrenia (−0.677). Conclusions Post hoc analyses showed that more cariprazine‐ than placebo‐treated patients with bipolar mania or schizophrenia had statistically significant and clinically meaningful CGI‐S improvement.