title: Safety and effectiveness of olanzapine in monotherapy: a multivariate analysis of a naturalistic study.
abstract: BACKGROUND
  This study investigated safety and effectiveness of olanzapine in monotherapy compared with conventional antipsychotics in treatment of acute inpatients with schizophrenia.
  
  
  METHODS
  This was a prospective, comparative, nonrandomized, open-label, multisite, observational study of Spanish inpatients with an acute episode of schizophrenia. Data included safety assessments with an extrapyramidal symptoms (EPS) questionnaire and the report of spontaneous adverse events, plus clinical assessments with the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity of Illness (CGI-S). A multivariate methodology was used to more adequately determine which factors can influence safety and effectiveness of olanzapine in monotherapy.
  
  
  RESULTS
  339 patients treated with olanzapine in monotherapy (OGm) and 385 patients treated with conventional antipsychotics (CG) were included in the analysis. Treatment-emergent EPS were significantly higher in the CG (p<0.0001). Response rate was significantly higher in the OGm (p=0.005). Logistic regression analyses revealed that the only variable significantly correlated with treatment-emergent EPS and clinical response was treatment strategy, with patients in OGm having 1.5 times the probability of obtaining a clinical response and patients in CG having 5 times the risk of developing EPS.
  
  
  CONCLUSIONS
  In this naturalistic study olanzapine in monotherapy was better-tolerated and at least as effective as conventional antipsychotics.
authors.affiliation: Lilly Research Laboratories, Avda.de la Industria, 30, 28108 Alcobendas, Madrid, Spain. CIUDAD_ANTONIO@LILLY.COM
authors.forename: Antonio
authors.initials: A
authors.lastname: Ciudad
authors.forename: Miguel
authors.initials: M
authors.lastname: Gutiérrez
authors.forename: Fernando
authors.initials: F
authors.lastname: Cañas
authors.forename: Juan
authors.initials: J
authors.lastname: Gibert
authors.forename: Josep
authors.initials: J
authors.lastname: Gascón
authors.forename: José-Luis
authors.initials: JL
authors.lastname: Carrasco
authors.forename: Julio
authors.initials: J
authors.lastname: Bobes
authors.forename: Juan-Carlos
authors.initials: JC
authors.lastname: Gómez
authors.forename: Enrique
authors.initials: E
authors.lastname: Alvarez
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001480:Basal Ganglia Diseases / Q000188:drug therapy / Q000209:etiology; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use; D003710:Demography; D004305:Dose-Response Relationship, Drug; D005260:Female; D006220:Haloperidol / Q000627:therapeutic use; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D000077152:Olanzapine; D011446:Prospective Studies; D012306:Risk; D012559:Schizophrenia / Q000150:complications / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D006220:Haloperidol; D000077152:Olanzapine