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Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based multi-center study in multiple sclerosis patients with a relapse

In a prospective multi-center observational study, we evaluated the frequency, severity, and impact on activities of daily living (ADL) of adverse effects (AEs) of high-dose intravenous methylprednisolone (IVMP) in relapsing remitting multiple sclerosis (MS) patients with a relapse. Online self-repo...

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Autores principales: Jongen, Peter Joseph, Stavrakaki, Ioanna, Voet, Bernard, Hoogervorst, Erwin, van Munster, Erik, Linssen, Wim H., Sinnige, Ludovicus G., Verhagen, Wim I., Visser, Leo H., van der Kruijk, Ruud, Verheul, Freek, Boringa, Jan, Heerings, Marco, Gladdines, Werner, Lönnqvist, Fredrik, Gaillard, Pieter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4971042/
https://www.ncbi.nlm.nih.gov/pubmed/27272956
http://dx.doi.org/10.1007/s00415-016-8183-3
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author Jongen, Peter Joseph
Stavrakaki, Ioanna
Voet, Bernard
Hoogervorst, Erwin
van Munster, Erik
Linssen, Wim H.
Sinnige, Ludovicus G.
Verhagen, Wim I.
Visser, Leo H.
van der Kruijk, Ruud
Verheul, Freek
Boringa, Jan
Heerings, Marco
Gladdines, Werner
Lönnqvist, Fredrik
Gaillard, Pieter
author_facet Jongen, Peter Joseph
Stavrakaki, Ioanna
Voet, Bernard
Hoogervorst, Erwin
van Munster, Erik
Linssen, Wim H.
Sinnige, Ludovicus G.
Verhagen, Wim I.
Visser, Leo H.
van der Kruijk, Ruud
Verheul, Freek
Boringa, Jan
Heerings, Marco
Gladdines, Werner
Lönnqvist, Fredrik
Gaillard, Pieter
author_sort Jongen, Peter Joseph
collection PubMed
description In a prospective multi-center observational study, we evaluated the frequency, severity, and impact on activities of daily living (ADL) of adverse effects (AEs) of high-dose intravenous methylprednisolone (IVMP) in relapsing remitting multiple sclerosis (MS) patients with a relapse. Online self-report questionnaires stating IVMP’s most common AEs were completed at baseline, the 2nd day of treatment, and 1 day and 1 week after treatment. Eighty-five patients were included, 66 completed the baseline questionnaire, and 59 completed at least one post-baseline questionnaire. Patients reported on average 4 (median) AEs; two (3.4 %) reported no AE. Most frequent was change in taste (61 %), facial flushing (61 %), sick/stomach pain (53 %), sleep disturbance (44 %), appetite change (37 %), agitation (36 %), and behavioral changes (36 %). Of all AEs, 34.3 % were severe and 37.9 % impacted on ADL. A 3-day course resulted in 4 (median) AEs and a 5-day course in 7. All patients with high disease impact had two or more AEs, compared with 79 % of those with low impact (p < 0.01). Of patients with high disability, 45 % had severe AEs, compared with 16 % of those with low disability. Severe central nervous system (CNS)-related AEs occurred two times more frequently in patients with high disease impact, and two-and-a-half times more frequently in patients with high disability. Therefore, in virtually all patients, high-dose IVMP leads to AEs, with about one of three AEs being severe with impact on ADL. Patients with high disease impact or high disability may experience more (severe) AEs, due to a higher occurrence of severe CNS-related AEs. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s00415-016-8183-3) contains supplementary material.
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spelling pubmed-49710422016-08-17 Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based multi-center study in multiple sclerosis patients with a relapse Jongen, Peter Joseph Stavrakaki, Ioanna Voet, Bernard Hoogervorst, Erwin van Munster, Erik Linssen, Wim H. Sinnige, Ludovicus G. Verhagen, Wim I. Visser, Leo H. van der Kruijk, Ruud Verheul, Freek Boringa, Jan Heerings, Marco Gladdines, Werner Lönnqvist, Fredrik Gaillard, Pieter J Neurol Original Communication In a prospective multi-center observational study, we evaluated the frequency, severity, and impact on activities of daily living (ADL) of adverse effects (AEs) of high-dose intravenous methylprednisolone (IVMP) in relapsing remitting multiple sclerosis (MS) patients with a relapse. Online self-report questionnaires stating IVMP’s most common AEs were completed at baseline, the 2nd day of treatment, and 1 day and 1 week after treatment. Eighty-five patients were included, 66 completed the baseline questionnaire, and 59 completed at least one post-baseline questionnaire. Patients reported on average 4 (median) AEs; two (3.4 %) reported no AE. Most frequent was change in taste (61 %), facial flushing (61 %), sick/stomach pain (53 %), sleep disturbance (44 %), appetite change (37 %), agitation (36 %), and behavioral changes (36 %). Of all AEs, 34.3 % were severe and 37.9 % impacted on ADL. A 3-day course resulted in 4 (median) AEs and a 5-day course in 7. All patients with high disease impact had two or more AEs, compared with 79 % of those with low impact (p < 0.01). Of patients with high disability, 45 % had severe AEs, compared with 16 % of those with low disability. Severe central nervous system (CNS)-related AEs occurred two times more frequently in patients with high disease impact, and two-and-a-half times more frequently in patients with high disability. Therefore, in virtually all patients, high-dose IVMP leads to AEs, with about one of three AEs being severe with impact on ADL. Patients with high disease impact or high disability may experience more (severe) AEs, due to a higher occurrence of severe CNS-related AEs. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s00415-016-8183-3) contains supplementary material. Springer Berlin Heidelberg 2016-06-07 2016 /pmc/articles/PMC4971042/ /pubmed/27272956 http://dx.doi.org/10.1007/s00415-016-8183-3 Text en © The Author(s) 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Communication
Jongen, Peter Joseph
Stavrakaki, Ioanna
Voet, Bernard
Hoogervorst, Erwin
van Munster, Erik
Linssen, Wim H.
Sinnige, Ludovicus G.
Verhagen, Wim I.
Visser, Leo H.
van der Kruijk, Ruud
Verheul, Freek
Boringa, Jan
Heerings, Marco
Gladdines, Werner
Lönnqvist, Fredrik
Gaillard, Pieter
Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based multi-center study in multiple sclerosis patients with a relapse
title Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based multi-center study in multiple sclerosis patients with a relapse
title_full Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based multi-center study in multiple sclerosis patients with a relapse
title_fullStr Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based multi-center study in multiple sclerosis patients with a relapse
title_full_unstemmed Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based multi-center study in multiple sclerosis patients with a relapse
title_short Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based multi-center study in multiple sclerosis patients with a relapse
title_sort patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based multi-center study in multiple sclerosis patients with a relapse
topic Original Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4971042/
https://www.ncbi.nlm.nih.gov/pubmed/27272956
http://dx.doi.org/10.1007/s00415-016-8183-3
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