Change in clinical status, social functioning, weight and sexual adverse events over the first 6 months of treatment: pan-european results from the schizophrenia outpatient health outcomes (SOHO) study
© The Author(s) 2003
Received: 1 November 2003
Published: 23 December 2003
The Schizophrenia Outpatient Health Outcomes (SOHO) study is a 3-year, prospective, outpatient, observational study of health outcomes associated with antipsychotic treatment. 10,972 patients were enrolled upon initiation of or change to a new antipsychotic in actual outpatient treatment settings.
Material and Methods
Response in positive, negative, cognitive, depressive and overall symptoms from baseline to 6 months, as measured using CGI (Clinical Global Impression) scales, was assessed for patients enrolled in SOHO. Mean change in weight and Body Mass Index (BMI) from baseline to 6 months was also assessed. Sexual adverse events were collected by the physician using a patient-reported questionnaire with three options (no problems, some problems and unable to perform). A logistic regression model, adjusted for baseline covariates, compares the odds responding/having sexual adverse events in the olanzapine cohort with each of the other cohorts
6-month data had been collected on 9,028 patients with schizophrenia. Olanzapine (58%), clozapine (59%) and two or more antipsychotics (2+APs; 56%) cohorts had the highest proportion of patients who responded in terms of their overall symptoms [Other cohorts (range depot (41%) to risperidone (51%)]. The odds of responding in overall symptoms, at 6 months, in the olanzapine cohort compared with the other treatment cohorts were: risperidone (Odds Ratio: 1.32; 95% CI: 1.16–1.49), quetiapine (1.77; 1.48–2.12), amisulpride (1.60; 1.22–2.08), oral typical (1.60; 1.32–1.92) and depot typical (1.86; 1.49–2.32) cohorts. No statistical differences were observed between the olanzapine cohort and the clozapine (0.87; 0.68–1.13) and 2+AP's (0.89; 0.65–1.22) cohorts. Similar results were observed for response in positive, negative, cognitive and depressive symptoms and the EQ-VAS health state. Social functioning improved across all cohorts; the odds of being socially active in the olanzapine cohort compared to the other treatment cohorts were: risperidone (1.28; 1.06–1.55), quetiapine (1.66; 1.28–2.15), oral typical (1.71; 1.29–2.26) and depot typical (1.59; 1.15–2.21) cohorts. No statistical differences were observed between the olanzapine cohort and the amisulpride (1.15; 0.73–1.79), clozapine (1.25; 0.87–1.80) and 2+AP's (0.71; 0.44–1.15) cohorts.
Mean weight change between baseline and 6 months across cohorts ranged from 0.7 ± 5.0 kg for quetiapine treated patients to 2.4 ± 4.9 kg for olanzapine treated patients. Mean change in BMI between baseline and 6 months ranged from 0.3 ± 1.8 kg/m2 for quetiapine treated patients and 0.3 ± 1.7 kg/m2 for oral typical treated patients to 0.8 ± 1.7 kg/m2 for olanzapine treated patients and 0.8 ± 1.9 kg/m2for clozapine treated patients. The odds of patients having problems with their sexual functioning in the olanzapine cohort compared to the other treatment cohorts were: risperidone (odds ratio: 0.71; 95% CI: 0.61–0.82), oral typical (0.66, 0.53–0.82) and depot typical (0.68; 0.52–0.90) cohorts. No statistically significant differences were observed between the olanzapine cohort and the quetiapine (0.96; 0.78–1.19), amisulpride (0.78; 0.56–1.08), clozapine (1.13; 0.85–1.50) and 2+AP's (0.73; 0.50–1.07) cohorts.
After 6 months of treatment, patients in the olanzapine cohort were more likely to improve in terms of clinical status and social functioning compared with patients in the risperidone, quetiapine, oral typical and depot typical cohorts. No differences were observed between the olanzapine and the clozapine and 2+AP's cohorts. From baseline to 6 months, weight gain occurred across all antipsychotic treatment cohorts with olanzapine treated patients experiencing more weight gain than patients treated with other antipsychotics. Findings suggest that patients in the olanzapine, quetiapine, amisulpride, clozapine and 2+AP's are less likely to develop problems with their sexual functioning compared with patients in the other cohorts.