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No difference in nonsuicide mortality between 2 anti-psychotic drugs
Date:11/12/2010

iprasidone and olanzapine, another second-generation anti-psychotic approved by the FDA for the treatment of schizophrenia and bipolar disorder. Brian Strom, MD, director of the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania School of Medicine, chaired the steering committee that designed and directed the ZODIAC study. Strom is also chair of the Department of Biostatistics and Epidemiology and Vice Dean for Institutional Affairs in the School of Medicine.

Olanzapine (marketed as Zyprexa and other brands names by Eli Lilly and Comp.) was selected for comparison in the study because it was not linked to QTc prolongation in the literature or in a controlled pharmacokinetic study of several agents compared with ziprasidone. The main objective of ZODIAC was to evaluate nonsuicide mortality, which limited the study's ability to provide data on drug efficacy.

ZODIAC, an open-label, randomized trial, enrolled over 18,000 patients with schizophrenia in 18 countries. The primary outcome measure was nonsuicide mortality in the year after initiation of treatment. Patients were randomly assigned to receive treatment with either ziprasidone or olanzapine and followed for one year by unblinded investigators providing usual care. A physician-administered questionnaire was used to collect baseline demographic information, medical and psychiatric history, and concomitant medication use. Follow-up information on hospitalizations and emergency department visits, patients' vital status, and current antipsychotic drug status was also collected.

A total of 205 deaths occurred overall in the study population. Despite the known risk of QTc prolongation with ziprasidone treatment, the findings did not show that ziprasidone is associated with an elevated risk of nonsuicidal mortality relative to olanzapine in real-world use. However the study was not designed to examine the risk of rare cardiac events associated with lengthen
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Contact: Karen Kreeger
karen.kreeger@uphs.upenn.edu
215-349-5658
University of Pennsylvania School of Medicine
Source:Eurekalert

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