Document Detail


Methodological challenges in the coding and adjudication of sudden deaths in a large simple trial with observational follow-up: the ziprasidone observational study of cardiac outcomes (ZODIAC).
MedLine Citation:
PMID:  21796719     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: The Ziprasidone Observational study of car DIAC Outcomes (ZODIAC), a large simple trial comparing ziprasidone versus olanzapine in real-world use, showed no difference in risk of sudden death. Upon the request of the US Food and Drug Administration, 205 fatal events were readjudicated applying ICD-10 coding rules for sudden death.
METHODS: A readjudication committee coded three domains (witness to death, time of symptom onset to death, and most likely cause of death) for use within algorithms consistent with ICD-10 rules. Relative risks (RR) and corresponding 95%CI were calculated for persons randomized to ziprasidone versus olanzapine, comparing 1-year incidence of sudden death, using multiple definitions.
RESULTS: Data on symptom onset to death and diagnosis of specific cardiac arrhythmias required by the ICD-10 rules were often lacking. Sensitivity analyses were conducted to explore the impact of cases suggestive of cardiac origin but missing data required by ICD-10 sudden death codes. Overall, the readjudicated data matched the study's initial findings, with no significant difference in 1-year mortality between ziprasidone and olanzapine for sudden death not otherwise specified and sudden cardiac death (R96.0 or R96.1 or I46.1; RR = 1.11, 95%CI 0.45- 2.77).
CONCLUSIONS: After outcome readjudication, ZODIAC found no difference in the risk of sudden death among those randomized to ziprasidone versus olanzapine. However, unlike hospital-based studies, fatal events in general population studies often occur outside hospital and often lack the clinical detail needed for the exact determination of symptom onset and event. Epidemiological evaluations of sudden death need to consider the limitations of the available data.
Authors:
Jamie L Geier; Onur N Karayal; Michael Lewis; John A Camm; Martin Keane; Charlotte M E Kremer; Sheela Kolluri; Robert Reynolds; Sybil Eng; Brian L Strom
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2011-07-27
Journal Detail:
Title:  Pharmacoepidemiology and drug safety     Volume:  20     ISSN:  1099-1557     ISO Abbreviation:  Pharmacoepidemiol Drug Saf     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2011-10-24     Completed Date:  2012-08-13     Revised Date:  2012-10-25    
Medline Journal Info:
Nlm Unique ID:  9208369     Medline TA:  Pharmacoepidemiol Drug Saf     Country:  England    
Other Details:
Languages:  eng     Pagination:  1192-8     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 John Wiley & Sons, Ltd.
Affiliation:
Pfizer Inc, New York, NY, USA. Jamie.Geier@Pfizer.com
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00174447
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MeSH Terms
Descriptor/Qualifier:
Antipsychotic Agents / therapeutic use,  toxicity*
Benzodiazepines / therapeutic use,  toxicity*
Cause of Death
Clinical Coding / methods*,  statistics & numerical data
Death, Sudden / epidemiology*,  etiology*
Death, Sudden, Cardiac / epidemiology,  etiology
Endpoint Determination / statistics & numerical data
Follow-Up Studies
Heart
Humans
Incidence
International Classification of Diseases / statistics & numerical data
Piperazines / therapeutic use,  toxicity*
Product Surveillance, Postmarketing / statistics & numerical data
Questionnaires
Research Design
Risk
Schizophrenia / drug therapy,  mortality
Sensitivity and Specificity
Thiazoles / therapeutic use,  toxicity*
Time Factors
United States
United States Food and Drug Administration
Chemical
Reg. No./Substance:
0/Antipsychotic Agents; 0/Piperazines; 0/Thiazoles; 12794-10-4/Benzodiazepines; 132539-06-1/olanzapine; 146939-27-7/ziprasidone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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