Safety and effectiveness of olanzapine in monotherapy: A multivariate analysis of a naturalistic study

• Published in: Progress in neuro-psychopharmacology & biological psychiatry Vol. 29; no. 6; pp. 944 - 951
• Main Authors: Ciudad, Antonio, Gutiérrez, Miguel, Cañas, Fernando, Gibert, Juan, Gascón, Josep, Carrasco, José-Luis, Bobes, Julio, Gómez, Juan-Carlos, Alvarez, Enrique
• Format: Journal Article
• Language: English
• Published: England Elsevier Inc 01.07.2005
• Subjects: Acute episode; Adult; Antipsychotic Agents - adverse effects; Antipsychotic Agents - therapeutic use; Basal Ganglia Diseases - drug therapy; Basal Ganglia Diseases - etiology; Benzodiazepines - adverse effects; Benzodiazepines - therapeutic use; Conventional antipsychotics; Demography; Dose-Response Relationship, Drug; Female; Haloperidol - therapeutic use; Humans; Inpatients; Logistic Models; Male; Middle Aged; Multivariate Analysis; Naturalistic study; Olanzapine in monotherapy; Prospective Studies; Risk; Schizophrenia; Schizophrenia - complications; Schizophrenia - drug therapy; Severity of Illness Index; Treatment Outcome; Olanzapine in monotherapy; ICD-10; CG; Acute episode; LOCF; Naturalistic study; Schizophrenia; EPS; BPRS; Inpatients; OGm; Conventional antipsychotics; CGI-S; CA; NOSIE; UKU; WHO
• ISSN: 0278-5846
• DOI: 10.1016/j.pnpbp.2005.04.037

This study investigated safety and effectiveness of olanzapine in monotherapy compared with conventional antipsychotics in treatment of acute inpatients with schizophrenia. 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. 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. In this naturalistic study olanzapine in monotherapy was better-tolerated and at least as effective as conventional antipsychotics.