Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia

Jennifer Kern Sliwa,1 Cynthia A Bossie,1 Dong-Jing Fu,1 Ibrahim Turkoz,2 Larry Alphs11Janssen Scientific Affairs LLC, 2Janssen Research and Development, LLC, Titusville, NJ, USABackground: A post hoc analysis from a multiphase trial with open-label transition and maintenance phases, a double-blind r...

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Autores principales:	Sliwa JK, Bossie CA, Fu D-J, Turkoz I, Alphs L
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2012
Materias:	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/66dd7875e7674fe5b5a049c23e8d9364
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spelling	oai:doaj.org-article:66dd7875e7674fe5b5a049c23e8d93642021-12-02T02:18:11ZLong-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia1176-63281178-2021https://doaj.org/article/66dd7875e7674fe5b5a049c23e8d93642012-08-01T00:00:00Zhttp://www.dovepress.com/long-term-tolerability-of-once-monthly-injectable-paliperidone-palmita-a10822https://doaj.org/toc/1176-6328https://doaj.org/toc/1178-2021Jennifer Kern Sliwa,1 Cynthia A Bossie,1 Dong-Jing Fu,1 Ibrahim Turkoz,2 Larry Alphs11Janssen Scientific Affairs LLC, 2Janssen Research and Development, LLC, Titusville, NJ, USABackground: A post hoc analysis from a multiphase trial with open-label transition and maintenance phases, a double-blind relapse prevention phase, and an optional open-label extension examined the long-term tolerability with continuous once-monthly injectable paliperidone palmitate 39, 78, 117, or 156 mg (25, 50, 75, or 100 mg equivalents [mg eq] of paliperidone) in subjects with recently diagnosed (&le;5 years; n = 216) versus chronic illness (&gt;5 years; n = 429) schizophrenia.Methods: Adverse events reported at a &ge;2% margin between subgroups were identified. Relative risks (in the recently diagnosed compared with the chronically ill) and 95% confidence intervals (CI) were determined, and CI not including 1 were considered potentially significant.Results: In both subgroups, the mean monthly dose was 109 mg (69.9 mg eq). Continuous mean exposures were 333.9 &plusmn; 271.9 and 308.7 &plusmn; 278.3 days in the recently diagnosed and chronic illness subgroups, respectively. Using the criteria outlined in the methods, nasopharyngitis was a potentially significant event reported in more chronically ill than recently diagnosed subjects at months 6, 9, 12, and endpoint (7.2% versus 2.8%; relative risk 0.384; 95% CI 0.163&ndash;0.907). Influenza (2.8% versus 0.7%; relative risk 3.9; 95% CI 1.003&ndash;15.730) and amenorrhea (3.2% versus 0.9%; relative risk 3.476; 95% CI 1.029&ndash;11.744) at endpoint were potentially significant events in more recently diagnosed than chronically ill subjects. Mean weight changes, sedation/somnolence, any extrapyramidal symptom-related or glucose-related events were generally similar between the groups. The mean prolactin level increased in both sexes in both subgroups (changes from baseline of +41.8 ng/mL and +26.5 ng/mL in recently diagnosed and chronic illness females and +12.3 ng/mL and +15.1 ng/mL in recently diagnosed and chronic illness males, respectively), and were higher in females with recently diagnosed illness than in females who were chronically ill (P = 0.0002 at endpoint). Prolactin-related events were reported by 7.9% of recently diagnosed subjects with schizophrenia and 3.5% of those who were chronically ill.Conclusion: The long-term tolerability of paliperidone palmitate was generally similar in recently diagnosed schizophrenia subjects and those with more chronic illness, with the exception of some prolactin-related measures.Keywords: paliperidone palmitate, long-acting antipsychotic, recently diagnosed, early illness, schizophreniaSliwa JKBossie CAFu D-JTurkoz IAlphs LDove Medical PressarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2012, Iss default, Pp 375-385 (2012)
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 Sliwa JK Bossie CA Fu D-J Turkoz I Alphs L Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia
description	Jennifer Kern Sliwa,1 Cynthia A Bossie,1 Dong-Jing Fu,1 Ibrahim Turkoz,2 Larry Alphs11Janssen Scientific Affairs LLC, 2Janssen Research and Development, LLC, Titusville, NJ, USABackground: A post hoc analysis from a multiphase trial with open-label transition and maintenance phases, a double-blind relapse prevention phase, and an optional open-label extension examined the long-term tolerability with continuous once-monthly injectable paliperidone palmitate 39, 78, 117, or 156 mg (25, 50, 75, or 100 mg equivalents [mg eq] of paliperidone) in subjects with recently diagnosed (&le;5 years; n = 216) versus chronic illness (&gt;5 years; n = 429) schizophrenia.Methods: Adverse events reported at a &ge;2% margin between subgroups were identified. Relative risks (in the recently diagnosed compared with the chronically ill) and 95% confidence intervals (CI) were determined, and CI not including 1 were considered potentially significant.Results: In both subgroups, the mean monthly dose was 109 mg (69.9 mg eq). Continuous mean exposures were 333.9 &plusmn; 271.9 and 308.7 &plusmn; 278.3 days in the recently diagnosed and chronic illness subgroups, respectively. Using the criteria outlined in the methods, nasopharyngitis was a potentially significant event reported in more chronically ill than recently diagnosed subjects at months 6, 9, 12, and endpoint (7.2% versus 2.8%; relative risk 0.384; 95% CI 0.163&ndash;0.907). Influenza (2.8% versus 0.7%; relative risk 3.9; 95% CI 1.003&ndash;15.730) and amenorrhea (3.2% versus 0.9%; relative risk 3.476; 95% CI 1.029&ndash;11.744) at endpoint were potentially significant events in more recently diagnosed than chronically ill subjects. Mean weight changes, sedation/somnolence, any extrapyramidal symptom-related or glucose-related events were generally similar between the groups. The mean prolactin level increased in both sexes in both subgroups (changes from baseline of +41.8 ng/mL and +26.5 ng/mL in recently diagnosed and chronic illness females and +12.3 ng/mL and +15.1 ng/mL in recently diagnosed and chronic illness males, respectively), and were higher in females with recently diagnosed illness than in females who were chronically ill (P = 0.0002 at endpoint). Prolactin-related events were reported by 7.9% of recently diagnosed subjects with schizophrenia and 3.5% of those who were chronically ill.Conclusion: The long-term tolerability of paliperidone palmitate was generally similar in recently diagnosed schizophrenia subjects and those with more chronic illness, with the exception of some prolactin-related measures.Keywords: paliperidone palmitate, long-acting antipsychotic, recently diagnosed, early illness, schizophrenia
format	article
author	Sliwa JK Bossie CA Fu D-J Turkoz I Alphs L
author_facet	Sliwa JK Bossie CA Fu D-J Turkoz I Alphs L
author_sort	Sliwa JK
title	Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia
title_short	Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia
title_full	Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia
title_fullStr	Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia
title_full_unstemmed	Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia
title_sort	long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia
publisher	Dove Medical Press
publishDate	2012
url	https://doaj.org/article/66dd7875e7674fe5b5a049c23e8d9364
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Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia

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