Twelve-month results from the world's largest real-world schizophrenia study show that people receiving atypical, or newer generation, antipsychotics benefited more than those receiving the older typicals across a range of efficacy and safety parameters. The data also indicated that patients treated with olanzapine (Zyprexa) experienced a range of modest but identifiable advantages when compared to those treated with other leading antipsychotics. The 12-month results of the ongoing Schizophrenia Outpatient Health Outcomes (SOHO) study were presented during the annual meeting of the German Association of Psychiatrists, Psychotherapists and Neurologists (DGPPN).
"First-year results of this study clearly indicate that atypicals provide advantages across a range of efficacy and safety parameters, including the management of positive, negative, depressive and cognitive symptoms, when compared to typicals," said Dieter Naber, MD, professor and chairman, department of psychiatry, University of Hamburg.
"Among the first-line atypicals, patients remained longer on olanzapine than on other drug therapies during the first year of the SOHO study. In clinical practice, we see that a therapy's enduring efficacy helps patients and physicians work together toward realizing a patients individual potential," said Naber.
As a study of schizophrenia treatments, SOHO is unprecedented in size and scope, evaluating a total of more than 17,750 patients in two studies in 37 countries. Ten countries in western Europe and 27 countries throughout Asia, central and eastern Europe, Latin America and the Middle East are involved in the study. The observational trial is collecting data in the real-world setting of physicians' offices over three years. By evaluating patients who seek treatment in typical outpatient settings, SOHO differs from traditional clinical trials, which often have rigid exclusion criteria that limit the kinds of patients who participate. The SOHO study complements this traditional approach by providing data on people's daily experiences with antipsychotics.
Patients taking atypicals had superior outcomes to those taking typicals in the management of positive (delusions and hallucinations), negative (diminished emotion, lack of interest), depressive, cognitive and overall symptoms.
Patients taking atypicals had a lower incidence of extrapyramidal symptoms (EPS) of shaking, spasms, or restlessness, when compared with patients on typicals.
Patients taking atypicals required anticholinergic drugs less often to control tremors than those treated with typicals.
Patients treated with olanzapine showed clinical improvement in positive, negative, depressive, cognitive and overall symptoms compared to patients on risperidone (Risperdal), quetiapine (Seroquel), oral typical and depot typical antipsychotics. No significant differences were found between olanzapine and clozapine (Clozaril), which is typically used as a second-line antipsychotic.
Olanzapine-treated patients were more likely to continue therapy throughout the first year of the study without changing medications when compared to those taking other first-line atypical antipsychotics. Olanzapine-treated patients had the lowest overall rate of EPS compared with patients on all other studied drugs. Fewer patients treated with olanzapine required the use of an anticholinergic drug. Weight gain was highest in patients treated with olanzapine and clozapine as compared with other drugs.
The study is collecting long-term data on several antipsychotic treatments, including typicals, depot formulations and atypicals such as olanzapine, clozapine, quetiapine, risperidone and amisulpride (Solian). Eli Lilly and Company sponsors the study.
The SOHO study will look at more than 30 areas over the course of three years to assess how treatment patterns affect patients' living conditions, clinical status, health-related quality of life, and ability to work and socialize. It will also assess treatment tolerability, compliance, victimization, violence and resource use.
Patients undergoing treatment in the outpatient setting for schizophrenia were enrolled if, at the direction of the treating psychiatrist, they started or changed antipsychotic medication. Three treatment groups were established post hoc: olanzapine, risperidone and 'other antipsychotics' (non-olanzapine including risperidone) treatment. Measures of treatment effectiveness (overall, positive, negative, cognitive and depressive domains), safety (incidence of EPS or tardive dyskinesia), side effects (sexual dysfunction and weight gain) and functional status (social and work functioning) were taken at the start of the study (baseline) and at three, six and 12 months.
Schizophrenia is a severe and debilitating psychosis often characterized by acute episodes of delusions (false beliefs that cannot be corrected by reason), hallucinations (usually in the form of non-existent voices) and long-term impairments such as diminished emotion, lack of interest and depressive signs and symptoms. It is usually associated with a disruption in social and family relationships. Schizophrenia is the most common severe mental illness. There are as many as 50 million people with schizophrenia worldwide, more than 33 million of them in developing countries. Symptoms of schizophrenia usually begin to appear in the teenage years or early to mid-twenties.