Time to onset and time to resolution of extrapyramidal symptoms in patients with exacerbated schizophrenia treated with 3-monthly vs once-monthly paliperidone palmitate

Maju Mathews,1 Isaac Nuamah,1 Adam J Savitz,1 David W Hough,1 Dean Najarian,2 Edward Kim,2 Srihari Gopal1 1Janssen Research and Development, LLC, Titusville, NJ, USA; 2Janssen Scientific Affairs, Titusville, LLC, NJ, USA Objective: The aim of this study was to evaluate the safety of 3-monthly pali...

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Autores principales:	Mathews M, Nuamah I, Savitz AJ, Hough DW, Najarian D, Kim E, Gopal S
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	extrapyramidal symptoms paliperidone palmitate once-monthly paliperidone palmitate 3-monthly time-to-onset time-to-resolution Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/65792ee977724b2386b52b08d8e5f73b
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spelling	oai:doaj.org-article:65792ee977724b2386b52b08d8e5f73b2021-12-02T01:46:03ZTime to onset and time to resolution of extrapyramidal symptoms in patients with exacerbated schizophrenia treated with 3-monthly vs once-monthly paliperidone palmitate1178-2021https://doaj.org/article/65792ee977724b2386b52b08d8e5f73b2018-10-01T00:00:00Zhttps://www.dovepress.com/time-to-onset-and-time-to-resolution-of-extrapyramidal-symptoms-in-pat-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Maju Mathews,1 Isaac Nuamah,1 Adam J Savitz,1 David W Hough,1 Dean Najarian,2 Edward Kim,2 Srihari Gopal1 1Janssen Research and Development, LLC, Titusville, NJ, USA; 2Janssen Scientific Affairs, Titusville, LLC, NJ, USA Objective: The aim of this study was to evaluate the safety of 3-monthly paliperidone palmitate (PP3M) vs once-monthly paliperidone palmitate (PP1M) treatment with regard to extrapyramidal symptom (EPS)-related treatment-emergent adverse events (TEAEs) in patients with schizophrenia, previously stabilized on PP1M treatment. Patients and methods: Data on overall incidence, time to onset (TTO), and time to resolution (TTR) of EPS-related TEAEs (overall, subclasses such as dyskinesia, dystonia, hyperkinesia, parkinsonism, and tremor) from a randomized double-blind (DB) non-inferiority study were compared between PP3M and PP1M. Subgroup analysis was performed by age (18–25, 26–50, and 50+ years) and final open-label (OL) dose (50/75, 100, and 150 mg eq.). Results: Overall incidence of spontaneously reported EPS-related TEAEs decreased from 12.6% (PP1M) in OL phase to 8.3% (PP3M) and 7.4% (PP1M) in the DB phase; overall median TTO and TTR values were comparable between both groups. Among patients with reported EPS-related TEAEs, the median TTO for all EPS-related TEAEs was 17 days (PP1M) in OL phase and 115 days (PP3M) and 98.5 days (PP1M) in DB phase; median TTR was 36.5 days (PP1M) in OL phase and 91 days (PP3M) and 85.5 days (PP1M) in DB phase. No clear dose- or age-related differences in TTO and TTR of EPS-related TEAEs were noted. Conclusion: Despite differences in apparent half-life and pharmacokinetic profiles (peak plasma exposure of PP3M formulation is 70% higher than that of PP1M formulation), both PP3M and PP1M formulations exhibited comparable incidence of EPS-related TEAEs, TTO, and TTR in patients with schizophrenia. Keywords: extrapyramidal symptoms, once-monthly paliperidone palmitate, 3-monthly paliperidone palmitate, time to onset, time to resolutionMathews MNuamah ISavitz AJHough DWNajarian DKim EGopal SDove Medical Pressarticleextrapyramidal symptomspaliperidone palmitate once-monthlypaliperidone palmitate 3-monthlytime-to-onsettime-to-resolutionNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol Volume 14, Pp 2807-2816 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	extrapyramidal symptoms paliperidone palmitate once-monthly paliperidone palmitate 3-monthly time-to-onset time-to-resolution Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	extrapyramidal symptoms paliperidone palmitate once-monthly paliperidone palmitate 3-monthly time-to-onset time-to-resolution Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Mathews M Nuamah I Savitz AJ Hough DW Najarian D Kim E Gopal S Time to onset and time to resolution of extrapyramidal symptoms in patients with exacerbated schizophrenia treated with 3-monthly vs once-monthly paliperidone palmitate
description	Maju Mathews,1 Isaac Nuamah,1 Adam J Savitz,1 David W Hough,1 Dean Najarian,2 Edward Kim,2 Srihari Gopal1 1Janssen Research and Development, LLC, Titusville, NJ, USA; 2Janssen Scientific Affairs, Titusville, LLC, NJ, USA Objective: The aim of this study was to evaluate the safety of 3-monthly paliperidone palmitate (PP3M) vs once-monthly paliperidone palmitate (PP1M) treatment with regard to extrapyramidal symptom (EPS)-related treatment-emergent adverse events (TEAEs) in patients with schizophrenia, previously stabilized on PP1M treatment. Patients and methods: Data on overall incidence, time to onset (TTO), and time to resolution (TTR) of EPS-related TEAEs (overall, subclasses such as dyskinesia, dystonia, hyperkinesia, parkinsonism, and tremor) from a randomized double-blind (DB) non-inferiority study were compared between PP3M and PP1M. Subgroup analysis was performed by age (18–25, 26–50, and 50+ years) and final open-label (OL) dose (50/75, 100, and 150 mg eq.). Results: Overall incidence of spontaneously reported EPS-related TEAEs decreased from 12.6% (PP1M) in OL phase to 8.3% (PP3M) and 7.4% (PP1M) in the DB phase; overall median TTO and TTR values were comparable between both groups. Among patients with reported EPS-related TEAEs, the median TTO for all EPS-related TEAEs was 17 days (PP1M) in OL phase and 115 days (PP3M) and 98.5 days (PP1M) in DB phase; median TTR was 36.5 days (PP1M) in OL phase and 91 days (PP3M) and 85.5 days (PP1M) in DB phase. No clear dose- or age-related differences in TTO and TTR of EPS-related TEAEs were noted. Conclusion: Despite differences in apparent half-life and pharmacokinetic profiles (peak plasma exposure of PP3M formulation is 70% higher than that of PP1M formulation), both PP3M and PP1M formulations exhibited comparable incidence of EPS-related TEAEs, TTO, and TTR in patients with schizophrenia. Keywords: extrapyramidal symptoms, once-monthly paliperidone palmitate, 3-monthly paliperidone palmitate, time to onset, time to resolution
format	article
author	Mathews M Nuamah I Savitz AJ Hough DW Najarian D Kim E Gopal S
author_facet	Mathews M Nuamah I Savitz AJ Hough DW Najarian D Kim E Gopal S
author_sort	Mathews M
title	Time to onset and time to resolution of extrapyramidal symptoms in patients with exacerbated schizophrenia treated with 3-monthly vs once-monthly paliperidone palmitate
title_short	Time to onset and time to resolution of extrapyramidal symptoms in patients with exacerbated schizophrenia treated with 3-monthly vs once-monthly paliperidone palmitate
title_full	Time to onset and time to resolution of extrapyramidal symptoms in patients with exacerbated schizophrenia treated with 3-monthly vs once-monthly paliperidone palmitate
title_fullStr	Time to onset and time to resolution of extrapyramidal symptoms in patients with exacerbated schizophrenia treated with 3-monthly vs once-monthly paliperidone palmitate
title_full_unstemmed	Time to onset and time to resolution of extrapyramidal symptoms in patients with exacerbated schizophrenia treated with 3-monthly vs once-monthly paliperidone palmitate
title_sort	time to onset and time to resolution of extrapyramidal symptoms in patients with exacerbated schizophrenia treated with 3-monthly vs once-monthly paliperidone palmitate
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/65792ee977724b2386b52b08d8e5f73b
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Time to onset and time to resolution of extrapyramidal symptoms in patients with exacerbated schizophrenia treated with 3-monthly vs once-monthly paliperidone palmitate

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