Differences in the incidence of lurasidone adverse events between depressive disorders and schizophrenia in double-blind, randomized, placebo-controlled trials: a meta-analysis.

Abstract

We conducted a meta-analysis of double-blind, randomized placebo-controlled trials of lurasidone (LUR) to examine the difference in the risk ratios (RRs) for adverse events (AEs) between depressive disorders (bipolar depression and major depressive disorders) and schizophrenia. Three trials for depressive disorders (n = 1,239) were used for flexible-dose LUR 20-60 (LUR20-60) and/or 80-120 (LUR80-120) mg/day. Nine schizophrenia trials (n = 2,684) were used for fixed-dose LUR.The RRs of LUR20-60 and LUR80-120 for depressive disorders were compared with those of LUR 40 (LUR40) and LUR 80 (LUR80) mg/day for schizophrenia, respectively, to match LUR dose. LUR20-60 caused a higher incidence of akathisia (RR = 2.28; p = 0.003) and weight gain (RR = 4.11; p = 0.05) than placebo in patients with depressive disorders, and LUR40 caused a higher incidence of akathisia (RR = 2.39; p = 0.0001), extrapyramidal symptoms (RR = 1.88; p = 0.02), anticholinergic drug use (RR = 1.58; p = 0.005), somnolence (RR = 2.19; p = 0.002), and dizziness (RR = 2.06; p = 0.05) than placebo in patients with schizophrenia. However, no significant differences in the RRs for all outcomes were found between depressive disorders and schizophrenia. LUR80-120 caused a higher incidence of akathisia (RR = 3.90; p < 0.0001), extrapyramidal symptoms (RR = 2.26; p = 0.04), anticholinergic use (RR = 4.70; p < 0.0001), and nausea (RR = 2.15; p = 0.001) than placebo in patients with depressive disorders. LUR80 caused a higher incidence of akathisia (RR = 2.99; p < 0.0001), extrapyramidal symptoms (RR = 2.55; p = 0.01), anticholinergic use (RR = 1.86; p = 0.01), somnolence (RR = 2.46; p = 0.001), and nausea (RR = 1.64; p = 0.04) than placebo in patients with schizophrenia. Depressive disorders had a higher RR for anticholinergic use than schizophrenia (p = 0.04). The incidence of AEs did not differ between schizophrenia and depressive disorders.