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Relating Spontaneously Reported Extrapyramidal Adverse Events to Movement Disorder Rating Scales

BACKGROUND: While antipsychotic-induced extrapyramidal symptoms (EPS) and akathisia remain important concerns in the treatment of patients with schizophrenia, the relationship between movement disorder rating scales and spontaneously reported EPS-related adverse events (EPS-AEs) remains unexplored....

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Autores principales: Widschwendter, Christian G., Karayal, Onur N., Kolluri, Sheela, Vanderburg, Douglas, Kemmler, Georg, Fleischhacker, W. Wolfgang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4675975/
https://www.ncbi.nlm.nih.gov/pubmed/26116494
http://dx.doi.org/10.1093/ijnp/pyv064
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author Widschwendter, Christian G.
Karayal, Onur N.
Kolluri, Sheela
Vanderburg, Douglas
Kemmler, Georg
Fleischhacker, W. Wolfgang
author_facet Widschwendter, Christian G.
Karayal, Onur N.
Kolluri, Sheela
Vanderburg, Douglas
Kemmler, Georg
Fleischhacker, W. Wolfgang
author_sort Widschwendter, Christian G.
collection PubMed
description BACKGROUND: While antipsychotic-induced extrapyramidal symptoms (EPS) and akathisia remain important concerns in the treatment of patients with schizophrenia, the relationship between movement disorder rating scales and spontaneously reported EPS-related adverse events (EPS-AEs) remains unexplored. METHODS: Data from four randomized, placebo- and haloperidol-controlled ziprasidone trials were analyzed to examine the relationship between spontaneously reported EPS-AEs with the Simpson Angus Scale (SAS) and Barnes Akathisia Rating Scale (BARS). Categorical summaries were created for each treatment group to show the frequencies of subjects with EPS-AEs in each of the SAS and BARS categories at weeks 1, 3, and 6, and agreement between ratings was quantified by means of weighted kappa (κ). RESULTS: In general, we found greater frequencies of EPS-AEs with increasing severity of the SAS and BARS scores. The EPS-AEs reported with a “none” SAS score ranged from 0 to 22.2%, with a “mild” SAS score from 3.3 to 29.0%, and with a “moderate” SAS score from 0 to 100%. No subjects in any treatment group reported “severe” SAS scores or corresponding EPS-AEs. Agreement between SAS scores and EPS-AEs was poor for ziprasidone and placebo (κ < 0.2) and only slightly better for haloperidol. The EPS-AEs reported with “non questionable” BARS scores ranged from 1.9 to 9.8%, with “mild moderate” BARS scores from 12.8 to 54.6%, and with “marked severe” scores from 0 to 100%. Agreement was modest for ziprasidone and placebo (κ < 0.4) and moderate for haloperidol (κ < 0.6). CONCLUSIONS: These findings may reflect either underreporting of AEs by investigators and subjects or erroneous rating scale evaluations.
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spelling pubmed-46759752016-01-08 Relating Spontaneously Reported Extrapyramidal Adverse Events to Movement Disorder Rating Scales Widschwendter, Christian G. Karayal, Onur N. Kolluri, Sheela Vanderburg, Douglas Kemmler, Georg Fleischhacker, W. Wolfgang Int J Neuropsychopharmacol Research Article BACKGROUND: While antipsychotic-induced extrapyramidal symptoms (EPS) and akathisia remain important concerns in the treatment of patients with schizophrenia, the relationship between movement disorder rating scales and spontaneously reported EPS-related adverse events (EPS-AEs) remains unexplored. METHODS: Data from four randomized, placebo- and haloperidol-controlled ziprasidone trials were analyzed to examine the relationship between spontaneously reported EPS-AEs with the Simpson Angus Scale (SAS) and Barnes Akathisia Rating Scale (BARS). Categorical summaries were created for each treatment group to show the frequencies of subjects with EPS-AEs in each of the SAS and BARS categories at weeks 1, 3, and 6, and agreement between ratings was quantified by means of weighted kappa (κ). RESULTS: In general, we found greater frequencies of EPS-AEs with increasing severity of the SAS and BARS scores. The EPS-AEs reported with a “none” SAS score ranged from 0 to 22.2%, with a “mild” SAS score from 3.3 to 29.0%, and with a “moderate” SAS score from 0 to 100%. No subjects in any treatment group reported “severe” SAS scores or corresponding EPS-AEs. Agreement between SAS scores and EPS-AEs was poor for ziprasidone and placebo (κ < 0.2) and only slightly better for haloperidol. The EPS-AEs reported with “non questionable” BARS scores ranged from 1.9 to 9.8%, with “mild moderate” BARS scores from 12.8 to 54.6%, and with “marked severe” scores from 0 to 100%. Agreement was modest for ziprasidone and placebo (κ < 0.4) and moderate for haloperidol (κ < 0.6). CONCLUSIONS: These findings may reflect either underreporting of AEs by investigators and subjects or erroneous rating scale evaluations. Oxford University Press 2015-06-26 /pmc/articles/PMC4675975/ /pubmed/26116494 http://dx.doi.org/10.1093/ijnp/pyv064 Text en © The Author 2015. Published by Oxford University Press on behalf of CINP. http://creativecommons.org/licenses/by-nc/4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Research Article
Widschwendter, Christian G.
Karayal, Onur N.
Kolluri, Sheela
Vanderburg, Douglas
Kemmler, Georg
Fleischhacker, W. Wolfgang
Relating Spontaneously Reported Extrapyramidal Adverse Events to Movement Disorder Rating Scales
title Relating Spontaneously Reported Extrapyramidal Adverse Events to Movement Disorder Rating Scales
title_full Relating Spontaneously Reported Extrapyramidal Adverse Events to Movement Disorder Rating Scales
title_fullStr Relating Spontaneously Reported Extrapyramidal Adverse Events to Movement Disorder Rating Scales
title_full_unstemmed Relating Spontaneously Reported Extrapyramidal Adverse Events to Movement Disorder Rating Scales
title_short Relating Spontaneously Reported Extrapyramidal Adverse Events to Movement Disorder Rating Scales
title_sort relating spontaneously reported extrapyramidal adverse events to movement disorder rating scales
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4675975/
https://www.ncbi.nlm.nih.gov/pubmed/26116494
http://dx.doi.org/10.1093/ijnp/pyv064
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