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Long-term safety and tolerability of iloperidone: results from a 25-week, open-label extension trial.
MedLine Citation:
PMID:  23312567     Owner:  NLM     Status:  Publisher    
Introduction/Objective Long-term use of the atypical antipsychotic iloperidone has not been investigated at doses above 16 mg/d. This article describes safety and tolerability results from the 25-week open-label extension of a 4-week placebo- and ziprasidone-controlled clinical trial of iloperidone. METHODS: Patients received a dose of 24 mg/d (given as 12 mg twice daily; mean dose = 21.6 mg) that could be reduced to 12 mg/d (given once daily at bedtime) any time after day 35 at the investigator's discretion. RESULTS: A total of 72/173 patients (41.6%) completed the open-label extension. Treatment-emergent adverse events (TEAEs), most mild to moderate in severity, included headache (13.9%), weight increase (9.2%), dizziness (6.9%), nausea (6.4%), sedation (6.4%), and insomnia (5.2%). The only notable dose-related TEAEs were increased weight and headache. Levels of serum glucose, lipids, and prolactin were essentially unchanged or decreased during treatment. In general, akathisia and extrapyramidal symptoms (EPS) improved or were unchanged during treatment. There was no signal of worsening of efficacy based on changes from baseline in the Positive and Negative Syndrome Scale-Total. Discussion/Conclusion This study further supports the long-term safety and tolerability of iloperidone for the treatment of schizophrenia, including iloperidone's favorable effect on metabolic laboratory parameters and low propensity to cause akathisia or EPS.
Andrew J Cutler; Amir H Kalali; Greg W Mattingly; Jelena Kunovac; Xiangyi Meng
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-14
Journal Detail:
Title:  CNS spectrums     Volume:  -     ISSN:  1092-8529     ISO Abbreviation:  CNS Spectr     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9702877     Medline TA:  CNS Spectr     Country:  -    
Other Details:
Languages:  ENG     Pagination:  1-12     Citation Subset:  -    
1 Department of Psychiatry, University of Florida, Bradenton, Florida, USA.
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