META-ANALYSES OF THE EFFICACY OF ASENAPINE VS PLACEBO IN BIPOLAR I DISORDER AS MONOTHERAPY AND ADJUNCT THERAPY COMPARED WITH OTHER ATYPICAL ANTIPSYCHOTICS
United States of America 
1 slide(s) – English – 2011-03-13
META-ANALYSIS OF ASENAPINE FOR SCHIZOPHRENIA: COMPARISON WITH PLACEBO AND COMPARATIVE EFFICACY OF ALL ATYPICAL ANTIPSYCHOTICS USING HEAD-TO-HEAD RANDOMIZED TRIALS
Armin Szegedi,(1) Pierre Verweij,(2) Wilbert van Duijnhoven,(2) Mary Mackle,(1) Pilar Cazorla,(1) Craig Karson,(1) Hein Fennema(2)
(1)Merck, Rahway, NJ, USA; (2)MSD, Oss, the Netherlands
Introduction: Asenapine is an FDA-approved atypical antipsychotic (AAP) indicated 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 49 studies that was updated with data from 4 AAP-controlled asenapine trials.
Results: PANSS change from baseline with asenapine exceeded that of placebo (LOCF: 3.6 [95% CI, 1.3–5.8], P=0.001; MMRM: 4.1 [95% CI, 1.6–6.6], P=0.001), a treatment effect comparable to other antipsychotics (LOCF: 4.0 [95% CI, 1.5–6.5], P=0.001; MMRM: 4.8 [95% CI, 2.0–7.6], P=0.001). Head-to-head network meta-analysis reported comparable efficacy with asenapine and other AAPs; PANSS differences ranged from 3.9 points greater than ziprasidone (95% CI, 0.3–7.4) to 2.9 points less than olanzapine (95% CI, –5.9 to 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.
Funding Source: This research was supported by Merck, Whitehouse Station, NJ, USA. This presentation is supported by Merck (Whitehouse Station, NJ, USA) and H. Lundbeck A/S (Copenhagen, Denmark).
|
|
