Abstract
Clinical safety data for treatment of acute schizophrenia with olanzapine, a new atypical antipsychotic agent, are summarized. The primary clinical trial safety database included 2500 patients treated with olanzapine, 810 with haloperidol, and 236 with placebo. The overall discontinuation rate from olanzapine treatment was low. Significant adverse events included somnolence, weight gain, and asymptomatic treatment-emergent transaminase elevation. Minimal parkinsonism and akathisia with rare dystonia were noted. No hematotoxicity was noted. The incidence of seizures and sexual dysfunction was rare.
Publication types
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Comparative Study
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Meta-Analysis
MeSH terms
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Acute Disease
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Akathisia, Drug-Induced / etiology
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Antipsychotic Agents / adverse effects*
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Antipsychotic Agents / therapeutic use
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Benzodiazepines
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Blood Pressure / drug effects
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Clinical Trials as Topic
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Cross-Over Studies
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Dizziness / chemically induced
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Double-Blind Method
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Dystonia / chemically induced
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Haloperidol / therapeutic use
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Heart Rate / drug effects
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Humans
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Liver / enzymology
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Olanzapine
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Parkinson Disease, Secondary / chemically induced
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Pirenzepine / adverse effects
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Pirenzepine / analogs & derivatives*
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Pirenzepine / therapeutic use
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Placebos
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Psychiatric Status Rating Scales
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Randomized Controlled Trials as Topic
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Schizophrenia / drug therapy*
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Schizophrenic Psychology
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Sleep / drug effects
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Transaminases / blood
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Treatment Outcome
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Weight Gain
Substances
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Antipsychotic Agents
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Placebos
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Benzodiazepines
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Pirenzepine
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Transaminases
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Haloperidol
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Olanzapine