Long-term safety and tolerability of iloperidone: results from a 25-week,
open-label extension trial.
Author(s): Cutler AJ(1), Kalali AH, Mattingly GW, Kunovac J, Meng X.
Affiliation(s): Author information:
(1)Department of Psychiatry, University of Florida, Bradenton, FL, USA.
acutler@flcrc.com
Publication date & source: 2013, CNS Spectr. , 18(1):43-54
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.
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