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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| Format: | Article |
| Language: | English |
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Dove Medical Press
2018-10-01
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| Series: | Neuropsychiatric Disease and Treatment |
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| Online Access: | https://www.dovepress.com/time-to-onset-and-time-to-resolution-of-extrapyramidal-symptoms-in-pat-peer-reviewed-article-NDT |
| _version_ | 1818739917587480576 |
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| 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 |
| collection | DOAJ |
| 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 |
| first_indexed | 2024-12-18T01:32:27Z |
| format | Article |
| id | doaj.art-65792ee977724b2386b52b08d8e5f73b |
| institution | Directory Open Access Journal |
| issn | 1178-2021 |
| language | English |
| last_indexed | 2024-12-18T01:32:27Z |
| publishDate | 2018-10-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Neuropsychiatric Disease and Treatment |
| spelling | doaj.art-65792ee977724b2386b52b08d8e5f73b2022-12-21T21:25:33ZengDove Medical PressNeuropsychiatric Disease and Treatment1178-20212018-10-01Volume 142807281641755Time to onset and time to resolution of extrapyramidal symptoms in patients with exacerbated schizophrenia treated with 3-monthly vs once-monthly paliperidone palmitateMathews MNuamah ISavitz AJHough DWNajarian DKim EGopal SMaju 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 resolutionhttps://www.dovepress.com/time-to-onset-and-time-to-resolution-of-extrapyramidal-symptoms-in-pat-peer-reviewed-article-NDTextrapyramidal symptomspaliperidone palmitate once-monthlypaliperidone palmitate 3-monthlytime-to-onsettime-to-resolution |
| spellingShingle | 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 Neuropsychiatric Disease and Treatment extrapyramidal symptoms paliperidone palmitate once-monthly paliperidone palmitate 3-monthly time-to-onset time-to-resolution |
| 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_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_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_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 |
| topic | extrapyramidal symptoms paliperidone palmitate once-monthly paliperidone palmitate 3-monthly time-to-onset time-to-resolution |
| url | https://www.dovepress.com/time-to-onset-and-time-to-resolution-of-extrapyramidal-symptoms-in-pat-peer-reviewed-article-NDT |
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