Comparative Mortality Associated With Ziprasidone and Olanzapine in Real-World Use Among 18,154 Patients With Schizophrenia: The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC)

Strom, Brian L.; Eng, Sybil M.; Faich, Gerald; Reynolds, Robert F.; D'Agostino, Ralph B.; Ruskin, Jeremy; Kane, John M.

doi:10.1176/appi.ajp.2010.08040484

Cited by 122Schizophrenia research and treatmentCardiac Health and Mental HealthBipolar Disorder and Treatment

Comparative Mortality Associated With Ziprasidone and Olanzapine in Real-World Use Among 18,154 Patients With Schizophrenia: The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC)

Strom, Brian L., Eng, Sybil M., Faich, Gerald, Reynolds, Robert F., D'Agostino, Ralph B., Ruskin, Jeremy, Kane, John M.·2011·American Journal of Psychiatry

DOI 10.1176/appi.ajp.2010.08040484

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Abstract

Objective The authors compared 1-year mortality rates associated with ziprasidone and olanzapine in real-world use. Method The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC) was an open-label, randomized, postmarketing large simple trial that enrolled patients with schizophrenia (N=18,154) in naturalistic practice in 18 countries. The primary outcome measure was nonsuicide mortality in the year after initiation of assigned treatment. Patients were randomly assigned to receive treatment with either ziprasidone or olanzapine and followed for 1 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 collected and reported by treating psychiatrists. Post hoc analyses of sudden death, a secondary endpoint, were also conducted. Results The incidence of nonsuicide mortality within 1 year of initiating pharmacotherapy was 0.91 for ziprasidone (N=9,077) and 0.90 for olanzapine (N=9,077). The relative risk was 1.02 (95% CI=0.76-1.39). This finding was confirmed in numerous secondary and sensitivity analyses. Conclusions Despite the known risk of QTc prolongation with ziprasidone treatment, the findings of this study failed to show that ziprasidone is associated with an elevated ri…

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The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC)
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Authors: Strom, B. L., Eng, S. M., Faich, G., Reynolds, R. F., D'Agostino, R. B., Ruskin, J., & Kane, J. M.
Affiliations: Boston University (US)
From the Department of Biostatistics and Epidemiology, the Center for Clinical Epidemiology and Biostatistics, and the Center for Education and Research in Therapeutics, University of Pennsylvania School of Medicine, Philadelphia; the Department of Epidemiology, Safety, and Risk Management, Pfizer, Inc., New York; the Safety and Risk Management Unit, United BioSource Corporation, Blue Bell, Pa.; the Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans;...
ORCID: Reynolds, Robert F.
Ruskin, Jeremy
Kane, John M.
Venue: American Journal of Psychiatry
Publisher: American Psychiatric Association Publishing
Published: 2011-02
Volume: 168
Issue: 2
Pages: 193-201
ISSN: 0002-953X (ISSN-L)
1535-7228
DOI: 10.1176/appi.ajp.2010.08040484
OpenAlex: W2129132454
Cited by: 122
References: 21
Citations by year: 2026: 1 · 2025: 3 · 2024: 4 · 2023: 2 · 2022: 3 · 2021: 2 · 2020: 2 · 2019: 8 · 2018: 11 · 2017: 7 · 2016: 10 · 2015: 6 · 2014: 11 · 2013: 9 · 2012: 19
FWCI: 11.13
Type: journal article
Language: en
Open access: closed
Locations: American Journal of Psychiatry (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Health and Mental Health
Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
Keywords: ziprasidone, olanzapine, schizophrenia, sudden death, QTc prolongation, torsades de pointes, antipsychotic drugs, real-world applications
MeSH terms: Olanzapine, Adult, Benzodiazepines, Cause of Death, Cross-Sectional Studies, Female, Hospitalization, Humans, Long QT Syndrome, Male, Middle Aged, Myocardial Infarction, Piperazines, Product Surveillance, Postmarketing, Prospective Studies, Risk, Schizophrenia, Suicide, Thiazoles, Antipsychotic Agents, Incidence, Death, Sudden, Cardiac, Diabetic Ketoacidosis, Kaplan-Meier Estimate

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Comparative Mortality Associated With Ziprasidone and Olanzapine in Real-World Use Among 18,154 Patients With Schizophrenia: The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC)

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