title: Meta-analyses of the efficacy of asenapine for acute schizophrenia: comparisons with placebo and other antipsychotics.
abstract: BACKGROUND
  Asenapine is an approved treatment for schizophrenia in the United States.
  
  
  OBJECTIVE
  Meta-analyses were conducted to evaluate the efficacy of asenapine in acute schizophrenia compared with placebo and other antipsychotics.
  
  
  METHODS
  Four asenapine trials from the asenapine development program were pooled for the meta-analysis. To compare asenapine versus placebo treatment effect with other antipsychotics, we added integrated asenapine data to a previously published meta-analysis. For comparative efficacy of asenapine versus other second-generation antipsychotics (SGAs), data from a second published meta-analysis were combined with the 4 asenapine trials.
  
  
  METHODS
  To evaluate efficacy, mean change in Positive and Negative Syndrome Scale (PANSS) total score was examined in asenapine and other antipsychotics. To assess clinical relevance, PANSS response rates and associated odds ratios (ORs) for treatment response were assessed. To assess the relative efficacy of SGAs, a network meta-analysis with PANSS total score change was conducted by using data from the 2 published meta-analyses together with asenapine data.
  
  
  RESULTS
  Asenapine was superior to placebo with regard to mean change in PANSS total score (last observation carried forward [LOCF]: -3.6, P = .002; mixed model for repeated measures [MMRM]: -4.1, P = .001), an effect comparable to active controls from the same trials (LOCF: -4.0, P = .002; MMRM: -4.8, P = .001). PANSS responder rates were significantly better with asenapine versus placebo (OR, 1.9; P < .001) and comparable to active controls (OR, 1.7; P = .002). Effect sizes for asenapine were somewhat lower than those reported in the literature for other SGAs. Network meta-analysis also demonstrated that the efficacy of asenapine was comparable to that of other SGAs; estimated differences between asenapine and other SGAs ranged from 3.9 points (95% CI, 0.3 to 7.4) greater than ziprasidone to 2.9 points (95% CI, -0.1 to 5.9) less than olanzapine.
  
  
  CONCLUSIONS
  These meta-analyses indicate that the efficacy of asenapine for acute schizophrenia is superior to placebo and comparable to several other SGAs.
authors.affiliation: Merck, Rahway, NJ 07065, USA. armin.szegedi@merck.com
authors.forename: Armin
authors.initials: A
authors.lastname: Szegedi
authors.forename: Pierre
authors.initials: P
authors.lastname: Verweij
authors.forename: Wilbert
authors.initials: W
authors.lastname: van Duijnhoven
authors.forename: Mary
authors.initials: M
authors.lastname: Mackle
authors.forename: Pilar
authors.initials: P
authors.lastname: Cazorla
authors.forename: Hein
authors.initials: H
authors.lastname: Fennema
mesh_terms: D006801:Humans; D000208:Acute Disease; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use; D003986:Dibenzocycloheptenes; D006576:Heterocyclic Compounds, 4 or More Rings / Q000009:adverse effects / Q000627:therapeutic use; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D011594:Psychometrics; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy; D012565:Schizophrenic Psychology; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; C522667:asenapine; D003986:Dibenzocycloheptenes; D006576:Heterocyclic Compounds, 4 or More Rings