The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC): Design and Baseline Subject Characteristics
J Clin Psychiatry 2008;69(1):114-121
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: Ziprasidone has been used to treat schizophrenia
since 2000. It is unknown whether its modest QTc-prolonging effect increases
cardiovascular event risk.
Purpose: To describe the study design of the Ziprasidone
Observational Study of Cardiac Outcomes (ZODIAC).
Method: The study was conducted between February 2002 and
February 2006. One-year follow-up for the primary endpoint of nonsuicide death
ended in April 2007. ZODIAC is an open-label, randomized, postmarketing study
enrolling patients with schizophrenia in naturalistic practice in 18 countries.
The primary outcome measure was the rate of nonsuicide mortality in the year
after initial recommendation for therapy. Subjects were randomly assigned to
either ziprasidone or olanzapine, after which follow-up was conducted by
investigators aware of the assigned exposure. A physician-administered
questionnaire collected baseline information on patients' demographics, medical
and psychiatric history, and concomitant medication use. Data were
self-reported by patients or reported by enrolling physicians.
Results: ZODIAC enrolled 18,240 patients with schizophrenia.
Most (73.0%) were from the United States or Brazil. Patients' baseline mean age
was 41.6 years, 55.1% were male, and 60.0% were white. At baseline,
approximately 18% had hypertension, 14.8% had hyperlipidemia, 46.5% currently
smoked, 28.9% had a body mass index >= 30 kg/m2, and 7.7% had
diabetes. Mean time from schizophrenia diagnosis to study enrollment was 10.4
years and mean Clinical Global Impressions scale score was 5.2 (range: 1-8).
Nearly one third of patients had ever attempted suicide. Seventy-one percent
were using antipsychotics at baseline. Almost 80% were using concomitant
medications, with 29.5% using antidepressants, 25.4% using anxiolytics, and
19.0% using mood stabilizers. Less than 3% were using antihypertensives or
Conclusions: ZODIAC is a uniquely designed study with an
initial randomization to ziprasidone or olanzapine and follow-up largely
consistent with usual practice (i.e., many characteristics of a nonexperimental
study). Baseline data suggest this study population has a substantial
prevalence of cardiovascular risk factors. Concomitant medications were used
frequently, although hyperlipidemia and hypertension may be undertreated.