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Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database

BACKGROUND: Thiazolidinediones (TZDs), rosiglitazone (RGZ) and pioglitazone (PGZ) are widely used as hypoglycemic drugs in patients with type 2 diabetes mellitus. The aim of our study was to investigate the profile of adverse drug reactions (ADRs) related to TZDs and to investigate potential risk fa...

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Autores principales: Berthet, Stephanie, Olivier, Pascale, Montastruc, Jean-Louis, Lapeyre-Mestre, Maryse
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3119167/
https://www.ncbi.nlm.nih.gov/pubmed/21609444
http://dx.doi.org/10.1186/1472-6904-11-5
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author Berthet, Stephanie
Olivier, Pascale
Montastruc, Jean-Louis
Lapeyre-Mestre, Maryse
author_facet Berthet, Stephanie
Olivier, Pascale
Montastruc, Jean-Louis
Lapeyre-Mestre, Maryse
author_sort Berthet, Stephanie
collection PubMed
description BACKGROUND: Thiazolidinediones (TZDs), rosiglitazone (RGZ) and pioglitazone (PGZ) are widely used as hypoglycemic drugs in patients with type 2 diabetes mellitus. The aim of our study was to investigate the profile of adverse drug reactions (ADRs) related to TZDs and to investigate potential risk factors of these ADRs. METHODS: Type 2 diabetic patients were identified from the French Database of PharmacoVigilance (FPVD) between 2002 and 2006. We investigated ADR related to TZD, focusing on 4 ADR: edema, heart failure, myocardial infarction and hepatitis corresponding to specific WHO-ART terms. RESULTS: Among a total of 99,284 adult patients in the FPVD, 2295 reports concerned type 2 diabetic patients (2.3% of the whole database), with 161 (7%) exposed to TZDs. The frequency of edema and cardiac failure was significantly higher with TZDs than in other patients (18% and 7.4% versus 0.8% and 0.1% respectively, p < 0.001) whereas the frequency of hepatitis was similar (5.9% versus 4%, NS). A multiple logistic regression model taking into account potential confounding factors (age, gender, drug exposure and co-morbidities) found that TZD exposure remained associated with heart failure and edema, but not with hepatitis or myocardial infarction. CONCLUSIONS: Thiazolidinediones exposure is associated with an increased risk of edema and heart failure in patients with type 2 diabetes even when recommendations for use are respected. In contrast, the risk of hepatic reactions and myocardial infarction with this class of drugs seems to be similar to other hypoglycemic agents.
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spelling pubmed-31191672011-06-22 Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database Berthet, Stephanie Olivier, Pascale Montastruc, Jean-Louis Lapeyre-Mestre, Maryse BMC Clin Pharmacol Research Article BACKGROUND: Thiazolidinediones (TZDs), rosiglitazone (RGZ) and pioglitazone (PGZ) are widely used as hypoglycemic drugs in patients with type 2 diabetes mellitus. The aim of our study was to investigate the profile of adverse drug reactions (ADRs) related to TZDs and to investigate potential risk factors of these ADRs. METHODS: Type 2 diabetic patients were identified from the French Database of PharmacoVigilance (FPVD) between 2002 and 2006. We investigated ADR related to TZD, focusing on 4 ADR: edema, heart failure, myocardial infarction and hepatitis corresponding to specific WHO-ART terms. RESULTS: Among a total of 99,284 adult patients in the FPVD, 2295 reports concerned type 2 diabetic patients (2.3% of the whole database), with 161 (7%) exposed to TZDs. The frequency of edema and cardiac failure was significantly higher with TZDs than in other patients (18% and 7.4% versus 0.8% and 0.1% respectively, p < 0.001) whereas the frequency of hepatitis was similar (5.9% versus 4%, NS). A multiple logistic regression model taking into account potential confounding factors (age, gender, drug exposure and co-morbidities) found that TZD exposure remained associated with heart failure and edema, but not with hepatitis or myocardial infarction. CONCLUSIONS: Thiazolidinediones exposure is associated with an increased risk of edema and heart failure in patients with type 2 diabetes even when recommendations for use are respected. In contrast, the risk of hepatic reactions and myocardial infarction with this class of drugs seems to be similar to other hypoglycemic agents. BioMed Central 2011-05-24 /pmc/articles/PMC3119167/ /pubmed/21609444 http://dx.doi.org/10.1186/1472-6904-11-5 Text en Copyright ©2011 Berthet et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Berthet, Stephanie
Olivier, Pascale
Montastruc, Jean-Louis
Lapeyre-Mestre, Maryse
Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database
title Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database
title_full Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database
title_fullStr Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database
title_full_unstemmed Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database
title_short Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database
title_sort drug safety of rosiglitazone and pioglitazone in france: a study using the french pharmacovigilance database
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3119167/
https://www.ncbi.nlm.nih.gov/pubmed/21609444
http://dx.doi.org/10.1186/1472-6904-11-5
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