The Safety and Efficacy of Ziprasidone: Post-Marketing Surveillance Study in Korea / 대한정신약물학회지

ABSTRACT

OBJECTIVE: The aim of this study was to observe the safety and efficacy of ziprasidone in the usual care setting in patients with schizophrenia or acute manic or mixed episodes associated with bipolar disorder. METHODS: A total of 3,391 patients who were treated with ziprasidone were enrolled from 108 centers in Korea. Differences in the clinical global impression of severity and clinical global impression of improvement (CGI-I) were measured after 8+/-1 weeks administration of ziprasidone. Adverse events were observed in all subjects who were administered ziprasidone at least once. In 330 patients, the change of weight was evaluated. RESULTS: Ziprasidone was effective for most of schizophrenia and acute manic or mixed episodes associated with bipolar disorder patients. CGI-I score was improved in 84.8% of PP subjects. Of the subjects who did not complete the study, sixty-four (1.9%) subjects discontinued treatment due to adverse events. The most common adverse events were akathisia, somnolence, extrapyramidal symptoms and insomnia. In total, 6 serious adverse events were reported in 2 subjects, including psychotic disorder and suicidal attempt. Mean 0.9 kg of weight loss was observed. CONCLUSION: Ziprasidone was effective, safe and generally well tolerated for schizophrenia or acute manic or mixed episodes associated with bipolar disorder patients in Korea.