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Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada

This survey analyzes two national pharmacovigilance databases in order to determine the major adverse reactions observed with the use of cholinesterase inhibitors in dementia. We conducted a statistical analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) and the Canad...

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Autores principales: Ali, Thibault B., Schleret, Thomas R., Reilly, Brian M., Chen, Winston Yuchen, Abagyan, Ruben
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4671709/
https://www.ncbi.nlm.nih.gov/pubmed/26642212
http://dx.doi.org/10.1371/journal.pone.0144337
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author Ali, Thibault B.
Schleret, Thomas R.
Reilly, Brian M.
Chen, Winston Yuchen
Abagyan, Ruben
author_facet Ali, Thibault B.
Schleret, Thomas R.
Reilly, Brian M.
Chen, Winston Yuchen
Abagyan, Ruben
author_sort Ali, Thibault B.
collection PubMed
description This survey analyzes two national pharmacovigilance databases in order to determine the major adverse reactions observed with the use of cholinesterase inhibitors in dementia. We conducted a statistical analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) and the Canada Vigilance Adverse Reaction Database (CVARD) concerning the side effects of cholinesterase inhibitors. The statistics calculated for each adverse event were the frequency and the reporting odds ratios (ROR). A total of 9877 and 2247 reports were extracted from the FAERS and CVARD databases, respectively. A disproportionately higher frequency of reports of death as an adverse event for rivastigmine, compared to the other acetylcholinesterase inhibiting drugs, was observed in both the FAERS (ROR = 3.42; CI(95%) = 2.94–3.98; P<0.0001) and CVARD (ROR = 3.67; CI(95%) = 1.92–7.00; P = 0.001) databases. While cholinesterase inhibitors remain to be an important therapeutic tool against Alzheimer’s disease, the disproportionate prevalence of fatal outcomes with rivastigmine compared with alternatives should be taken into consideration.
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spelling pubmed-46717092015-12-10 Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada Ali, Thibault B. Schleret, Thomas R. Reilly, Brian M. Chen, Winston Yuchen Abagyan, Ruben PLoS One Research Article This survey analyzes two national pharmacovigilance databases in order to determine the major adverse reactions observed with the use of cholinesterase inhibitors in dementia. We conducted a statistical analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) and the Canada Vigilance Adverse Reaction Database (CVARD) concerning the side effects of cholinesterase inhibitors. The statistics calculated for each adverse event were the frequency and the reporting odds ratios (ROR). A total of 9877 and 2247 reports were extracted from the FAERS and CVARD databases, respectively. A disproportionately higher frequency of reports of death as an adverse event for rivastigmine, compared to the other acetylcholinesterase inhibiting drugs, was observed in both the FAERS (ROR = 3.42; CI(95%) = 2.94–3.98; P<0.0001) and CVARD (ROR = 3.67; CI(95%) = 1.92–7.00; P = 0.001) databases. While cholinesterase inhibitors remain to be an important therapeutic tool against Alzheimer’s disease, the disproportionate prevalence of fatal outcomes with rivastigmine compared with alternatives should be taken into consideration. Public Library of Science 2015-12-07 /pmc/articles/PMC4671709/ /pubmed/26642212 http://dx.doi.org/10.1371/journal.pone.0144337 Text en © 2015 Ali et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Ali, Thibault B.
Schleret, Thomas R.
Reilly, Brian M.
Chen, Winston Yuchen
Abagyan, Ruben
Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada
title Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada
title_full Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada
title_fullStr Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada
title_full_unstemmed Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada
title_short Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada
title_sort adverse effects of cholinesterase inhibitors in dementia, according to the pharmacovigilance databases of the united-states and canada
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4671709/
https://www.ncbi.nlm.nih.gov/pubmed/26642212
http://dx.doi.org/10.1371/journal.pone.0144337
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