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P0261 - Comparative mortality associated with ziprasidone vs. olanzapine in real-world use: The ziprasidone observational study of cardiac outcomes (zodiac)

Published online by Cambridge University Press:  16 April 2020

B.L. Strom ,
G. Faich ,
S.M. Eng ,
R.F. Reynolds ,
R.B. D'Agostino ,
J. Ruskin  and
J.M. Kane
B.L. Strom
Affiliation:
Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, and Center for Education and Research in Therapeutics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA
G. Faich
Affiliation:
Department of Epidemiology, United BioSource Corporation, Blue Bell, PA, USA
S.M. Eng
Affiliation:
Pfizer, Inc., New York, NY, USA
R.F. Reynolds
Affiliation:
Pfizer, Inc., New York, NY, USA
R.B. D'Agostino
Affiliation:
Boston University, Boston, MA, USA
J. Ruskin
Affiliation:
Massachusetts General Hospital, Boston, MA, USA
J.M. Kane
Affiliation:
Department of Psychiatry, Zucker Hillside Hospital, Glen Oaks, NY, USA

Abstract

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Background:

Whether the modest QTc-prolonging effect of ziprasidone increases cardiovascular event risk is unknown.

Methods:

The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC), an open-label, randomized, postmarketing study, enrolled patients with schizophrenia from routine clinical practice settings in 18 countries. The primary outcome was non-suicide mortality in the year after initiation of assigned treatment. A total of 18,154 subjects were randomized to ziprasidone or olanzapine, dosed according to enrolling physician's clinical judgment. A physician-administered baseline questionnaire collected information on demographics, medical and psychiatric history, and concomitant medication use. Brief follow-up questionnaires elicited hospitalization data since the last study visit, vital status, study medication continuation, and concomitant antipsychotic medication(s) use. ZODIAC study subjects reflected the general population of patients with schizophrenia.

Results:

The incidence of nonsuicide mortality within one year of initiating therapy was 0.91% for the ziprasidone group and 0.90% for the olanzapine group (both n = 9,077), relative risk (95% confidence interval [CI]) of 1.01 (0.75, 1.37). This finding was robust in numerous secondary and sensitivity analyses. Regarding secondary endpoints, the risk of all-cause mortality or cardiovascular mortality was similar among ziprasidone and olanzapine users; the incidence of all-cause hospitalizations was higher among ziprasidone users. The proportion of patients remaining on treatment at 6 months was lower for the ziprasidone group.

Conclusions:

ZODIAC is one of the largest randomized studies conducted to date of patients with schizophrenia. With substantial statistical power, the study found no difference in risk of nonsuicide death associated with the use of ziprasidone vs. olanzapine.

Type
Poster Session I: Neuroleptics and Antipsychotics
Information
European Psychiatry , Volume 23 , Issue S2: 16th AEP Congress - Abstract book - 16th AEP Congress , April 2008 , pp. S158
Copyright
Copyright © European Psychiatric Association 2008
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