The Safety of Olanzapine Compared With Other Antipsychotic Drugs: Results of an Observational Prospective Study in Patients With Schizophrenia (EFESO Study)

摘要: INTRODUCTION Results of controlled clinical trials should be confirmed through safety and effectiveness studies in nonselected patient cohorts treated according to routine practice. METHOD Outpatients with schizophrenia (ICD-10 criteria) entered this prospective, naturalistic study when they received a new prescription for an antipsychotic drug. Treatment assignment was based on purely criteria, as the did not include any experimental intervention. Safety evaluated collection spontaneous adverse events specific questionnaire extrapyramidal symptoms. Global status measured Clinical Impressions-Severity (CGI-S) Assessment Functioning (GAF) scales. RESULTS From 2967 patients included, 2128 were olanzapine monotherapy or combined other drugs (olanzapine group), 821 (control group). There no statistical differences between treatment groups at baseline regarding age, gender, disease duration, severity Olanzapine well tolerated effective study. Overall incidence significantly lower group compared control (p < .001). Somnolence weight gain more frequent group, akathisia, dystonia, syndrome, hypertonia, hypokinesia, tremor higher group. improvement endpoint, mean change CGI-S GAF, = .004). CONCLUSION These results show that is safe schizophrenic outpatients are consistent efficacy profile has shown previous trials.