Efficacy (NNT) and Tolerability (NNH) of Cariprazine in Bipolar Disorder

Background: Cariprazine is approved to treat manic, mixed, and depressive symptoms of bipolar I disorder. This analysis describes the efficacy and tolerability of cariprazine in bipolar I disorder using clinically relevant metrics of number needed to treat (NNT) and harm (NNH).

Methods: Data from randomized, double-blind, placebo-controlled cariprazine studies in patients with bipolar depression (cariprazine 1.5 and 3 mg/d) or bipolar manic/mixed episodes (cariprazine 3-12 mg/d) were analyzed. NNTs for cariprazine versus placebo for response and remission were calculated based on the Montgomery-Åsberg Depression Rating Scale (MADRS) at Week 6 (bipolar depression) or the Young Mania Rating Scale (YMRS) at Week 3 (bipolar mania). NNHs for cariprazine versus placebo were calculated for adverse events (AEs).

Results: In patients with bipolar depression (N=1383), NNTs versus placebo for response were 10 for both cariprazine 1.5 mg/d and 3 mg/d; NNTs versus placebo for remission were 10 and 13, respectively. For discontinuations due to AEs, rates were the same for cariprazine 1.5 and placebo; for 3 mg/d, the NNH versus placebo was 37. NNHs versus placebo for akathisia incidence were 30 and 14 for cariprazine 1.5 and 3 mg/d, respectively. In patients with bipolar mania (N=1037), NNTs versus placebo on response and remission were 5 and 7, respectively. NNHs versus placebo were 23 for AE discontinuation and 7 for incidence of akathisia. NNHs for somnolence and weight gain were >25 for all comparisons in both patient populations.

Conclusions: Cariprazine treatment appears to have a favorable benefit/risk profile in patients with bipolar I disorder.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.