Observational study of outpatients with schizophrenia in the Middle East and Africa — 3- and 6-month efficacy and safety results. The Intercontinental Schizophrenia Outpatient Health Outcomes Study

Abstract

Objectives. To examine the comparative outcomes associated with the antipsychotic treatment of outpatients with schizophrenia and to describe changes in clinical status over the first 6 months of treatment in participating patients from the Middle East and Africa (MEA).

Methods. The Intercontinental Schizophrenia Outpatient Health Outcomes (IC-SOHO) Study is a 3-year, prospective, observational study of health outcomes associated with antipsychotic medication in outpatients treated for schizophrenia. This article reports the 6-month interim results in the MEA region (N = 1399). Subjects, aged 18 years and over and undergoing treatment for schizophrenia were enrolled if, at the discretion of the treating psychiatrist, they initiated or changed antipsychotic medication. For the primary analyses, two treatment groups were established; viz. olanzapine and \'other antipsychotics\' (non-olanzapine including risperidone) groups. Subanalysis of olanzapine versus risperidone groups was also done as secondary comparison. Measures of treatment effectiveness (Clinical Global Impression of Severity (CGI-S)), and safety (incidence of extrapyramidal symptoms (EPS), tardive dyskinesia (TD), side-effects (sexual dysfunction and weight change)) were taken at baseline and at 3 and 6 months after enrolment.

Results. Olanzapine (58.9%) and risperidone (13.8%)) were the most frequently prescribed antipsychotics in this study. Coprescription of anticholinergics was at least four times more frequent for risperidone-treated patients than for those treated with olanzapine at any time point. Olanzapine was more efficacious in the treatment of overall symptom severity (CGI-S) than other antipsychotics or risperidone. In all other symptom domains (CGI-S), patients responded significantly better to treatment with olanzapine than to treatment with other antipsychotics. EPS significantly declined over the treatment period for patients taking olanzapine. Compared with patients on other antipsychotics, fewer patients receiving olanzapine therapy developed TD post-baseline. In addition, more patients on olanzapine therapy presented with a remission of TD symptoms after 3 and 6 months of treatment compared with patients on other antipsychotics and risperidone. The prevalence of side-effects associated with sexual function (loss of libido, impotence/sexual dysfunction) was significantly reduced (p < 0.001) with olanzapine treatment compared with other antipsychotics. Compared with those patients taking other antipsychotics or risperidone, fewer patients developed loss of libido, and more patients recovered from these symptoms in the course of 6 months of olanzapine treatment. Similarly, fewer olanzapine patients suffered from impotence/sexual dysfunction over the first 3 months of treatment, and more patients had recovered from pre-existing symptoms after 6 months than those taking other antipsychotics or risperidone. Patients taking olanzapine were significantly more likely to gain more than 7% of their baseline weight over a 6-month period.

Conclusions. Initial 3- and 6-month findings included in this progress report indicate that patients treated with olanzapine showed greater improvements in terms of effectiveness of treatment, and that this was associated with a more favourable overall safety profile than that of patients treated with other antipsychotics or risperidone.

South African Journal of Psychiatry Vol.11(1) 2005: 16-24