Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics

Larry Alphs,1 Cynthia A Bossie,1 Jennifer Kern Sliwa,2 Dong-Jing Fu,1 Yi-Wen Ma,3 Joseph Hulihan11CNS Medical Affairs, 2Medical Information, Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 3Biostatistics, B&amp;P, Janssen Research &amp; Development LLC, Titusville, NJ, USABackg...

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Autores principales:	Alphs L, Bossie CA, Sliwa JK, Fu DJ, Ma YW, Hulihan J
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2013
Materias:	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/d4e09e5894fa4a95aa787599beec5147
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spelling	oai:doaj.org-article:d4e09e5894fa4a95aa787599beec51472021-12-02T07:46:31ZPaliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics1176-63281178-2021https://doaj.org/article/d4e09e5894fa4a95aa787599beec51472013-03-01T00:00:00Zhttp://www.dovepress.com/paliperidone-palmitate-and-risperidone-long-acting-injectable-in-subje-a12375https://doaj.org/toc/1176-6328https://doaj.org/toc/1178-2021Larry Alphs,1 Cynthia A Bossie,1 Jennifer Kern Sliwa,2 Dong-Jing Fu,1 Yi-Wen Ma,3 Joseph Hulihan11CNS Medical Affairs, 2Medical Information, Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 3Biostatistics, B&amp;P, Janssen Research &amp; Development LLC, Titusville, NJ, USABackground: This post hoc subgroup analysis of a randomized, double-blind trial evaluated the response to treatment with two long-acting injectable atypical antipsychotics, ie, paliperidone palmitate and risperidone long-acting injectable (RLAI), in subjects with schizophrenia experiencing clinically significant symptoms despite recent treatment with oral risperidone only or other oral antipsychotics.Methods: Adult subjects were eligible for the 13-week, double-blind, double-dummy trial (NCT00589914) if they had an established diagnosis of schizophrenia for at least one year and a Positive and Negative Syndrome Scale (PANSS) total score of 60&ndash;120 inclusive at screening. Subjects received either paliperidone palmitate (234 mg, day 1; 156 mg, day 8; then once-monthly flexible dosing) or RLAI (25&ndash;50 mg biweekly, with oral risperidone supplementation on days 1&ndash;28), plus matched placebo injections/tablets.Results: This post hoc analysis reports data on 747 subjects who, within 2 weeks of starting double-blind study medication, had reportedly received oral risperidone only (paliperidone palmitate group, n = 126; RLAI group, n = 107), other oral antipsychotics (paliperidone palmitate group, n = 199; RLAI group, n = 203), or no antipsychotic (paliperidone palmitate group, n = 56; RLAI group, n = 56). Mean PANSS total scores improved significantly at end point across all subgroups (mean change from baseline ranged from &minus;17.5 to &minus;19.5, all P &lt; 0.0001). Clinical Global Impression-Severity and Personal and Social Performance scale measures also significantly improved from baseline (all P &lt; 0.0001).Conclusion: Treatment with paliperidone palmitate or RLAI resulted in a significant reduction in the symptoms of schizophrenia irrespective of previous recent treatment with oral risperidone only or other oral antipsychotics. For subjects who had previously received oral risperidone only, the difference in formulation was the main change in the intervention because the molecule delivered remained the same or similar. These data support the contribution of a long-acting formulation to improving the treatment response and suggest that nonadherence may be a significant contributor to inadequate efficacy of oral formulations in subjects with schizophrenia.Keywords: paliperidone palmitate, risperidone long-acting injection, schizophreniaAlphs LBossie CASliwa JKFu DJMa YWHulihan JDove Medical PressarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2013, Iss default, Pp 341-350 (2013)
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 Alphs L Bossie CA Sliwa JK Fu DJ Ma YW Hulihan J Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics
description	Larry Alphs,1 Cynthia A Bossie,1 Jennifer Kern Sliwa,2 Dong-Jing Fu,1 Yi-Wen Ma,3 Joseph Hulihan11CNS Medical Affairs, 2Medical Information, Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 3Biostatistics, B&amp;P, Janssen Research &amp; Development LLC, Titusville, NJ, USABackground: This post hoc subgroup analysis of a randomized, double-blind trial evaluated the response to treatment with two long-acting injectable atypical antipsychotics, ie, paliperidone palmitate and risperidone long-acting injectable (RLAI), in subjects with schizophrenia experiencing clinically significant symptoms despite recent treatment with oral risperidone only or other oral antipsychotics.Methods: Adult subjects were eligible for the 13-week, double-blind, double-dummy trial (NCT00589914) if they had an established diagnosis of schizophrenia for at least one year and a Positive and Negative Syndrome Scale (PANSS) total score of 60&ndash;120 inclusive at screening. Subjects received either paliperidone palmitate (234 mg, day 1; 156 mg, day 8; then once-monthly flexible dosing) or RLAI (25&ndash;50 mg biweekly, with oral risperidone supplementation on days 1&ndash;28), plus matched placebo injections/tablets.Results: This post hoc analysis reports data on 747 subjects who, within 2 weeks of starting double-blind study medication, had reportedly received oral risperidone only (paliperidone palmitate group, n = 126; RLAI group, n = 107), other oral antipsychotics (paliperidone palmitate group, n = 199; RLAI group, n = 203), or no antipsychotic (paliperidone palmitate group, n = 56; RLAI group, n = 56). Mean PANSS total scores improved significantly at end point across all subgroups (mean change from baseline ranged from &minus;17.5 to &minus;19.5, all P &lt; 0.0001). Clinical Global Impression-Severity and Personal and Social Performance scale measures also significantly improved from baseline (all P &lt; 0.0001).Conclusion: Treatment with paliperidone palmitate or RLAI resulted in a significant reduction in the symptoms of schizophrenia irrespective of previous recent treatment with oral risperidone only or other oral antipsychotics. For subjects who had previously received oral risperidone only, the difference in formulation was the main change in the intervention because the molecule delivered remained the same or similar. These data support the contribution of a long-acting formulation to improving the treatment response and suggest that nonadherence may be a significant contributor to inadequate efficacy of oral formulations in subjects with schizophrenia.Keywords: paliperidone palmitate, risperidone long-acting injection, schizophrenia
format	article
author	Alphs L Bossie CA Sliwa JK Fu DJ Ma YW Hulihan J
author_facet	Alphs L Bossie CA Sliwa JK Fu DJ Ma YW Hulihan J
author_sort	Alphs L
title	Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics
title_short	Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics
title_full	Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics
title_fullStr	Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics
title_full_unstemmed	Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics
title_sort	paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics
publisher	Dove Medical Press
publishDate	2013
url	https://doaj.org/article/d4e09e5894fa4a95aa787599beec5147
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Paliperidone palmitate and risperidone long-acting injectable in subjects with schizophrenia recently treated with oral risperidone or other oral antipsychotics

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