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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.
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.
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.
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.
Background: Investigate the safety and tolerability of rivastigmine capsules and transdermal patch in patients with moderate Alzheimer's disease receiving concomitant memantine.
Methods: Safety data from two prospective, open-label, multicenter trials were analyzed. Study US32: patients received rivastigmine capsules (3–12 mg/day) plus memantine (20 mg/day). Study US38: patients switched from donepezil to rivastigmine patches (4.6 mg/24 hours) immediately or following 7 days' withdrawal; ∼50% received concomitant memantine (20 mg/day).
Results: The rivastigmine patch demonstrated more favorable tolerability than rivastigmine capsules, being associated with fewer adverse events (AEs) (73% versus 83%), serious AEs (10% versus 23%) and gastrointestinal symptoms (4% versus 26% for nausea; 4% versus 11% for vomiting). Application site reactions occurred in 17% of patients.
Conclusion: Concomitant memantine treatment with rivastigmine patch and capsule is generally well tolerated. The favorable tolerability and safety profile of rivastigmine transdermal patch is not further improved with concomitant memantine. Recommendations to minimize application site reactions are provided.
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