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Study Finds No Difference in Nonsuicide Mortality Between Ziprasidone, Olanzapine PHILADELPHIA -- November 12, 2010 -- A study published early online and appearing in the February 2011 print issue of the American Journal of Psychiatry showed no difference in nonsuicide mortality between patients taking ziprasidone and another second-generation anti-psychotic in real-world use. The issue of ziprasidone lengthening the QTc interval has demanded much attention among clinicians since the drug was introduced in 2001, and questions remain as to whether the modest QTc prolongation caused by ziprasidone would translate into increased mortality for the patients using it. Because the number of patients exposed to ziprasidone at the time of marketing authorisation was too small to allow for estimation of QTc-related effects on mortality, and because such studies would not reflect real-world prescribing practices, the Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC) was initiated to provide safety assurance for the use of the drug. ZODIAC was a post-approval commitment by the drug’s manufacturer, Pfizer, Inc., to the US Food and Drug Administration (FDA). In the study, patients were randomised to either ziprasidone or olanzapine and were followed for 1 year by unblinded investigators providing usual care. Olanzapine 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. 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 was 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 lengthening of the QTc interval. “We could not disprove that the drug caused abnormal heart rhythms, but that was not the goal of the study,” said Brian Strom, MD, d Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania. “Our goal was to determine whether there was a difference in risk of nonsuicide death, and there was not.” SOURCE: University of Pennsylvania School of Medicine E-mail this page to a friend or colleague! To print, use this version