Safety and effectiveness of olanzapine in monotherapy: a multivariate analysis of a naturalistic study.
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.
Ciudad
Antonio
A
Lilly Research Laboratories, Avda.de la Industria, 30, 28108 Alcobendas, Madrid, Spain. CIUDAD_ANTONIO@LILLY.COM
Gutiérrez
Miguel
M
Cañas
Fernando
F
Gibert
Juan
J
Gascón
Josep
J
Carrasco
José-Luis
JL
Bobes
Julio
J
Gómez
Juan-Carlos
JC
Alvarez
Enrique
E
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
D014150:Antipsychotic Agents; D001569:Benzodiazepines; D006220:Haloperidol; D000077152:Olanzapine