Author(s)

John M. Kane, Wolfgang Fleischhacker, Francesca Kolitsopoulos, Onur N. Karayal, Jamie Geier, Cynthia Siu, Robert Reynolds, Gerald Faich, Brian L. Strom

Data Power (DP), Inc., Ringoes, USA.
Department of Biological Psychiatry, Medical University Innsbruck, Innsbruck, Austria.
Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Center for Pharmacoepidemiology Research and Training, University of Pennsylvania School of Medicine, Philadelphia, USA.
Department of Epidemiology, United BioSource Corporation, Blue Bell, USA.
Department of Psychiatry, Zucker Hillside Hospital, Glen Oaks, USA.
Pfizer Inc., New York, USA.

Background: Using baseline data from the Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC), we assessed disease characteristics and prevalence of select comorbidities among subjects with schizophrenia in different clinical settings across 18 countries. ZODIAC was a randomized, open-label, one-year, large simple trial (LST) that enrolled 18,239 individuals with schizophrenia. Methods: Subjects were randomized to open-label treatment with ziprasidone (n = 9120) or olanzapine (n = 9119) in naturalistic (usual care) settings and followed for one year. Study sites (n = 749) applied minimal selection criteria in an attempt to make the study population as representative as possible of those receiving treatment in “real world” circumstances across the countries. Results: Mean patient age was 41 years, 55% were male, 34% were markedly ill or presented with more severe disease, and 66% of subjects had one or more select comorbid conditions [i.e. heart attack, stroke, hypertension, CAD/angina, high cholesterol/triglycerides, diabetes, or overweight (BMI ≥ 25)] at baseline. History of suicide attempt was greatest in the US (38%), compared with Sweden (34%), Brazil/South America (26%), Asia (23%), and Eastern Europe (20%). Overweight or obesity was the most prevalent comorbid risk factor, representing 60% of enrolled subjects, 70% of US subjects compared with 30% in Asia and 52% - 64% in the other regions studied. High cholesterol/triglycerides levels were found in 23% of US subjects compared with a relatively low prevalence in other countries (3% - 11%). History of cardiovascular or diabetes-related comorbidities was found in 31% of subjects. Current smoking (46.5%) and past smoking (11.8%) were common with men dominating the proportion of current smokers: US (61%); Asia (60%); Sweden (50%); Eastern Europe (49%); and Latin America (44%). Conclusions: Our findings indicate substantial baseline variations across countries in demographics, comorbid conditions, and psychiatric disease history. These data provide an international epidemiologic picture of schizophrenia and may help guide future research and treatment initiatives.

Large Simple Trial; Schizophrenia; ZODIAC; Comorbidities

Kane, J. , Fleischhacker, W. , Kolitsopoulos, F. , Karayal, O. , Geier, J. , Siu, C. , Reynolds, R. , Faich, G. and Strom, B. (2012) Regional disease characteristics and comorbidities of patients with schizophrenia in the Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC): Findings from an international large simple trial. Open Journal of Psychiatry, 2, 423-432. doi: 10.4236/ojpsych.2012.224059.