Adverse Drug Events Related to Ziprasidone: A Meta-analysis of Randomized, Placebo-Controlled Trials

Study Objective. To assess the drug‐related risk of adverse events associated with ziprasidone. Design. Meta‐analysis of 19 randomized, placebo‐controlled trials. Patients. A total of 4132 adults taking oral ziprasidone who had adverse‐event data reported in the studies identified. Measurements and...

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Bibliographic Details
Published in:Pharmacotherapy 2011-09, Vol.31 (9), p.840-849
Main Authors: Harrington, Catherine A., English, Clayton
Format: Article
Language:English
Subjects:
adverse events
Antipsychotic Agents - adverse effects
Biological and medical sciences
Clinical trial. Drug monitoring
Clinical trials
Confidence intervals
Dose-Response Relationship, Drug
Drug therapy
Drug toxicity and drugs side effects treatment
drug-related risk
evidence-based medicine
General pharmacology
Humans
Insomnia
Medical sciences
meta-analysis
Miscellaneous (drug allergy, mutagens, teratogens...)
Pharmacology. Drug treatments
Piperazines - adverse effects
Placebos
Randomized Controlled Trials as Topic - statistics & numerical data
randomized placebo-controlled trials
Risk
Studies
Thiazoles - adverse effects
ziprasidone
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Summary:Study Objective. To assess the drug‐related risk of adverse events associated with ziprasidone. Design. Meta‐analysis of 19 randomized, placebo‐controlled trials. Patients. A total of 4132 adults taking oral ziprasidone who had adverse‐event data reported in the studies identified. Measurements and Main Results. A systematic review (January 1996‐October 2010) was conducted by using the EMBASE and MEDLINE databases to identify Cochrane reviews, controlled clinical trials, meta‐analyses, randomized controlled trials, and systematic reviews; studies were limited to those published in English and those conducted in humans. The www.ClinicalTrials.gov Web site was also searched for ziprasidone studies. A total of 887 citations were reviewed; 31 articles met the criteria for inclusion, of which 19 were included in the final analysis. Data were combined for the meta‐analysis by using the Mantel‐Haenszel method, random‐effects model at 95% confidence. The overall rate of treatment‐emergent adverse events for ziprasidone was 73% compared with 60% for patients receiving placebo (p
ISSN:0277-0008
1875-9114
DOI:10.1592/phco.31.9.840