P03-341 - Meta-analysis of the efficacy of asenapine for acute schizophrenia: comparisons with placebo and other atypical antipsychotics

Introduction Asenapine is an FDA-approved atypical antipsychotic (AAP) indicated in adults for treatment of schizophrenia. Objective Present meta-analyses of asenapine vs placebo and other antipsychotics in acute schizophrenia. Aim Further demonstrate the efficacy of asenapine in acute schizophrenia. Methods PANSS total score changes from baseline to week 6 were assessed using last observation carried forward (LOCF) and mixed model for repeated measures (MMRM). Comparisons of asenapine and antipsychotics vs placebo were obtained from 4 placebo-controlled asenapine studies. Head-to-head comparisons among AAPs assessed in the same trials (including those for which no direct comparisons are available) were conducted with network meta-analyses using a published database (Leucht et al, Am J Psychiatry 2009;166:152–166) of 74 studies updated with data from 5 AAP-controlled asenapine trials. Results PANSS change from baseline with asenapine exceeded that of placebo (LOCF: 3.7 [95% CI, 1.5–5.9], P = 0.001; MMRM: 4.1 [95% CI, 1.6–6.5], P = 0.001), a treatment effect comparable to other antipsychotics (LOCF: 4.1 [95% CI, 1.7–6.5], P = 0.001; MMRM: 4.6 [95% CI, 1.9–7.3], P = 0.001). Head-to-head network meta-analysis reported comparable efficacy with asenapine and other AAPs; PANSS differences ranged from 3.9 points better than ziprasidone (95% CI, 0.3–7.4) to 2.9 points worse than olanzapine (95% CI, -5.-0.1). Discussion These meta-analyses demonstrate superiority of asenapine over placebo in acute schizophrenia, with treatment effects of asenapine at least comparable to antipsychotics used in the same studies. Further, the network meta-analysis suggests the efficacy of asenapine for acute schizophrenia is comparable to that of established AAPs.