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

PHILADELPHIA - The potential for harmful side effects associated with anti-psychotic medications for treating schizophrenia is a frustration for mental-health professionals who must balance this with the positive benefits of drugs. For example, the issue of the antipsychotic drug ziprasidone lengthening the QTc interval, a possible indicator of life-threatening heart arrhythmias, has demanded much attention among clinicians since the drug was introduced in 2001.

Ziprasidone (marketed as Geodon and Zeldox by Pfizer Inc.) was the fifth second-generation anti-psychotic to gain Food and Drug Administration (FDA) approval. These second-generation drugs have been thought to be associated with a lower risk of suicides, better functional capacity, and an improved quality of life for people with schizophrenia. (It is well known that patients with schizophrenia suffer an overall increased risk of death.) But questions remained as to whether the modest QTc prolongation caused by ziprasidone would translate into increased mortality for the patients using it.

A study published online this month in the American Journal of Psychiatry in advance of print publication in February 2011 showed no difference in nonsuicide mortality between people taking ziprasidone and another second-generation anti-psychotic in real-world use.

Because the number of patients exposed to ziprasidone at the time of marketing authorization 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 FDA.

ZODIAC is an international, multimember, randomized trial designed to examine the risks of nonsuicidal mortality and hospitalization associated with z
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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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