Citation

Janicak PG, Winans EA. Neuropsychiatr. Dis. Treat. 2007; 3(6): 869-883.

Copyright

(Copyright © 2007, Dove Press)

DOI

unavailable

PMID

unavailable

Abstract

Paliperidone extended-release tablet (paliperidone ER; INVEGA™) is an oral antipsychotic for the treatment of schizophrenia. The recommended dose range is 3-12 mg per day. Paliperidone ER utilizes the OROS® delivery system, which allows for once-daily dosing. Its pharmacokinetic profile results in a more stable serum concentration. Paliperidone is 9-hydroxyrisperidone, the chief active metabolite of risperidone. It undergoes limited hepatic metabolism, thereby minimizing the risks of hepatic drug-drug and drug-disease interactions. Three 6-week trials in patients with acute schizophrenia reported that paliperidone ER was effective, well tolerated, and produced clinically meaningful improvements in personal and social functioning compared with placebo. Post-hoc analysis of these trials in various populations, including recently diagnosed, elderly and more severely ill patients, those with sleep disturbances and those with predominant negative symptoms demonstrated improvement as well. Paliperidone ER was also significantly better than placebo in the prevention of symptom recurrence in a 6-month maintenance study. The most common clinically relevant adverse events associated with paliperidone ER were extrapyramidal symptoms, tachycardia and somnolence. The incidence of Parkinsonism, akathisia and use of anticholinergic medications increased in a dose-related manner. Further, modest QTc interval prolongation was observed but did not produce clinical symptoms. Similar to risperidone, paliperidone ER is associated with increases in serum prolactin levels. Overall, paliperidone ER was effective, well tolerated and provides a new treatment option for patients with schizophrenia. © 2007 Dove Medical Press Limited. All rights reserved.

Language: en

Keywords

human; social interaction; MEDLINE; insomnia; Schizophrenia; aggression; schizophrenia; anxiety; psychosis; food; drug use; suicide attempt; clinical trial; disease severity; review; neuroleptic agent; sexual dysfunction; prolactin blood level; drug metabolism; elderly care; tachycardia; unclassified drug; area under the curve; quetiapine; somnolence; sleep disorder; drug mechanism; gastrointestinal symptom; thioridazine; cardiotoxicity; drug safety; placebo; drug blood level; benzodiazepine derivative; long term care; drug efficacy; drug receptor binding; extrapyramidal symptom; olanzapine; risperidone; drug tolerability; tremor; weight gain; drug withdrawal; impotence; akathisia; lorazepam; restlessness; amiodarone; drug distribution; chlorpromazine; recurrence risk; side effect; cholinergic receptor blocking agent; glucose blood level; lipid blood level; maintenance therapy; agitation; anorgasmia; galactorrhea; gynecomastia; parkinsonism; QT prolongation; quinidine; drug half life; dose response; insulin blood level; risk reduction; drug elimination; drug indication; sotalol; liver metabolism; motor dysfunction; dizziness; drug dose reduction; libido disorder; drug bioavailability; steady state; drug antagonism; Antipsychotic; amenorrhea; drug induced headache; drug dose increase; drug dose titration; lactation; clinical effectiveness; treatment duration; drug release; drug substitution; Clinical Global Impression scale; EMBASE; post hoc analysis; hyperkinesia; Positive and Negative Syndrome Scale; weight change; procainamide; drug protein binding; drug dose comparison; trimethoprim; drug delivery system; sustained release formulation; recommended drug dose; dose kidney function relation; Extended-release; gatifloxacin; moxifloxacin; OROS delivery system; paliperidone; Paliperidone