Paliperidone ER: a review of the clinical trial data

Philip G Janicak1, Elizabeth A Winans2,31Department of Psychiatry, Rush University Medical Center, Chicago, IL, USA; 2Previously Employed by Scientific Affairs, Ortho-McNeil Janssen, LLC, Chicago, IL, USA; 3Department of Pharmacy Practice, University of Missouri Kansas City, MO, USAAbstract: Paliper...

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Autores principales:	Philip G Janicak, Elizabeth A Winans
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2007
Materias:	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/aa571f618d154d3f9c9faa4de25e763c
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spelling	oai:doaj.org-article:aa571f618d154d3f9c9faa4de25e763c2021-12-02T11:20:04ZPaliperidone ER: a review of the clinical trial data1176-63281178-2021https://doaj.org/article/aa571f618d154d3f9c9faa4de25e763c2007-01-01T00:00:00Zhttp://www.dovepress.com/paliperidone-er-a-review-of-the-clinical-trial-data-a965https://doaj.org/toc/1176-6328https://doaj.org/toc/1178-2021Philip G Janicak1, Elizabeth A Winans2,31Department of Psychiatry, Rush University Medical Center, Chicago, IL, USA; 2Previously Employed by Scientific Affairs, Ortho-McNeil Janssen, LLC, Chicago, IL, USA; 3Department of Pharmacy Practice, University of Missouri Kansas City, MO, USAAbstract: Paliperidone extended-release tablet (paliperidone ER; INVEGATM) is an oral antipsychotic for the treatment of schizophrenia. The recommended dose range is 3&ndash;12 mg per day. Paliperidone ER utilizes the OROS&reg; 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&ndash;drug and drug&ndash;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.Keywords: paliperidone, extended-release, antipsychotic, schizophrenia Philip G JanicakElizabeth A WinansDove Medical PressarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2007, Iss Issue 6, Pp 869-883 (2007)
institution	DOAJ
collection	DOAJ
language	EN
topic	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Philip G Janicak Elizabeth A Winans Paliperidone ER: a review of the clinical trial data
description	Philip G Janicak1, Elizabeth A Winans2,31Department of Psychiatry, Rush University Medical Center, Chicago, IL, USA; 2Previously Employed by Scientific Affairs, Ortho-McNeil Janssen, LLC, Chicago, IL, USA; 3Department of Pharmacy Practice, University of Missouri Kansas City, MO, USAAbstract: Paliperidone extended-release tablet (paliperidone ER; INVEGATM) is an oral antipsychotic for the treatment of schizophrenia. The recommended dose range is 3&ndash;12 mg per day. Paliperidone ER utilizes the OROS&reg; 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&ndash;drug and drug&ndash;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.Keywords: paliperidone, extended-release, antipsychotic, schizophrenia
format	article
author	Philip G Janicak Elizabeth A Winans
author_facet	Philip G Janicak Elizabeth A Winans
author_sort	Philip G Janicak
title	Paliperidone ER: a review of the clinical trial data
title_short	Paliperidone ER: a review of the clinical trial data
title_full	Paliperidone ER: a review of the clinical trial data
title_fullStr	Paliperidone ER: a review of the clinical trial data
title_full_unstemmed	Paliperidone ER: a review of the clinical trial data
title_sort	paliperidone er: a review of the clinical trial data
publisher	Dove Medical Press
publishDate	2007
url	https://doaj.org/article/aa571f618d154d3f9c9faa4de25e763c
work_keys_str_mv	AT philipgjanicak paliperidoneerareviewoftheclinicaltrialdata AT elizabethawinans paliperidoneerareviewoftheclinicaltrialdata
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Paliperidone ER: a review of the clinical trial data

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