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January 15, 2008The Journal of Clinical Psychiatry

The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC)

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Key result

Baseline data from 18,240 patients with schizophrenia randomized to ziprasidone or olanzapine showed high cardiovascular risk, including 46.5% current smokers and 28.9% with obesity.

Why the study?

Does ziprasidone compared to olanzapine increase the risk of nonsuicide mortality in patients with schizophrenia?

Population

18,240 patients with schizophrenia in naturalistic practice, mean age 41.6 years, 55.1% male, from 18…

Comparison

Ziprasidone vs Olanzapine

Design

RCT, Randomly assigned to either ziprasidone or olanzapine, Open-label

Follow-up

1 year

Authors

BSBrian L. StormGFGerald A. FaichRRRobert F. Reynolds

Discussion

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Overview

High CV risk in schizophrenia warrants monitoring; leaves open whether ziprasidone or olanzapine modifies outcomes.

Study Design

Type

RCT (n=18,240)

Blinding

Open-label

Randomization

Randomized

Multicenter

Yes

Structured PICO

Does ziprasidone compared to olanzapine increase the risk of nonsuicide mortality in patients with schizophrenia?

P
Population
18,240 patients with schizophrenia enrolled in a randomized, open-label postmarketing study across 18 countries with 1-year follow-up.
I
Intervention
Ziprasidone
C
Comparator
Olanzapine
O
Outcome
Rate of nonsuicide mortality in the year after initial recommendation for therapyhard clinical

The ZODIAC study is a large, pragmatic randomized trial designed to evaluate the cardiovascular safety of ziprasidone versus olanzapine in patients with schizophrenia, a population with a high prevalence of undertreated cardiovascular risk factors.

Cite This Study

Storm et al. (2008) conducted an RCT in Schizophrenia (n=18,240). Ziprasidone vs. Olanzapine was evaluated on Rate of nonsuicide mortality in the year after initial recommendation for therapy. Baseline data from 18,240 patients with schizophrenia randomized to ziprasidone or olanzapine showed high cardiovascular risk, including 46.5% current smokers and 28.9% with obesity.

synapsesocial.com/papers/6a6c19c46f523709a024f189https://doi.org/10.4088/jcp.v69n0115
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