title: Safety and effectiveness of olanzapine versus conventional antipsychotics in the acute treatment of first-episode schizophrenic inpatients.
abstract: OBJECTIVE
  To assess the safety and effectiveness of olanzapine compared to typical antipsychotics in the treatment of first-episode schizophrenics in acute psychiatric inpatient wards.
  
  
  METHODS
  Data were collected from a prospective, comparative, nonrandomized, open, observational study of 904 inpatients with schizophrenia. One hundred and fifty-eight patients fulfilled the criteria for first-episode schizophrenia, defined as (1) the International Classification of Diseases: Mental and Behavioral Disorders, 10th ed. (ICD-10) diagnosis of schizophrenia, (2) antipsychotic nai;ve, and (3) a course of illness of less than 5 years. Eighty-nine (56.3%) of these patients were assigned to the olanzapine treatment group (OLZ) and 69 (43.7%) to the control group that received treatment with conventional antipsychotics (CON). Safety was evaluated in terms of the spontaneous adverse events reported and a specific questionnaire for extrapyramidal symptoms (EPS). Clinical status was measured by means of the Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression of Severity (CGI-S). Clinical response was defined as the baseline-endpoint decrease in BPRS>40% plus an endpoint BPRS<18 or an endpoint CGI</=3.
  
  
  RESULTS
  The rate of clinical response to treatment in the OLZ was 76.7%, compared to 54.4% in the CON (chi(2)=8.48; P=.003). Olanzapine was significantly more effective than conventional antipsychotics in lowering the total BPRS score (P=.0003), as well as each of the following BPRS subscales: positive symptoms (P=.0019), negative symptoms (P<.0001), depression (P=.018), and agitation (P=.007), even after mean scores were adjusted for their baseline value and disease duration. Olanzapine also proved to be significantly superior to conventional antipsychotics in lowering mean CGI scores (P=.013). The frequency with which new EPS appeared, or previously existing ones worsened, was significantly greater in the CON than in the OLZ (55.1% vs. 13.5%; P<.001). Anticholinergics were needed more frequently in the CON than in the OLZ (58.0% vs. 6.7%; P<.0001).
  
  
  CONCLUSIONS
  The results of this observational, naturalistic study show that olanzapine is safe and effective in a nonselected sample of acute, first-episode schizophrenic inpatients.
authors.affiliation: Facultad de Medicina, Departamento de Psiquiatría, Universidad de Oviedo, Metropolitan Area of Ovieda, Calle Julián Clavería 6, E-33006 Oviedo, Asturias, Spain. bobes@correo.uniovi.es
authors.forename: Julio
authors.initials: J
authors.lastname: Bobes
authors.forename: Juan
authors.initials: J
authors.lastname: Gibert
authors.forename: Antonio
authors.initials: A
authors.lastname: Ciudad
authors.forename: Enrique
authors.initials: E
authors.lastname: Alvarez
authors.forename: Fernando
authors.initials: F
authors.lastname: Cañas
authors.forename: José-Luis
authors.initials: JL
authors.lastname: Carrasco
authors.forename: Josep
authors.initials: J
authors.lastname: Gascón
authors.forename: Juan-Carlos
authors.initials: JC
authors.lastname: Gómez
authors.forename: Miguel
authors.initials: M
authors.lastname: Gutiérrez
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001569:Benzodiazepines; D005260:Female; D006801:Humans; D007297:Inpatients / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D000077152:Olanzapine; D010890:Pirenzepine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D011446:Prospective Studies; D012559:Schizophrenia / Q000188:drug therapy*
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D010890:Pirenzepine; D000077152:Olanzapine