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Acute kidney injury associated with febuxostat and allopurinol: a post-marketing study

BACKGROUND: For patients with recurrent flares of gout, tophi, urate crystal arthropathy, and renal stones, urate-lowering therapies (ULTs, including allopurinol and febuxostat) are the first-line treatment. Due to the widespread use of these ULTs (especially in patients with impaired renal function...

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Autores principales: Rey, Amayelle, Batteux, Benjamin, Laville, Solène M., Marienne, Justine, Masmoudi, Kamel, Gras-Champel, Valérie, Liabeuf, Sophie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6842268/
https://www.ncbi.nlm.nih.gov/pubmed/31703711
http://dx.doi.org/10.1186/s13075-019-2011-y
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author Rey, Amayelle
Batteux, Benjamin
Laville, Solène M.
Marienne, Justine
Masmoudi, Kamel
Gras-Champel, Valérie
Liabeuf, Sophie
author_facet Rey, Amayelle
Batteux, Benjamin
Laville, Solène M.
Marienne, Justine
Masmoudi, Kamel
Gras-Champel, Valérie
Liabeuf, Sophie
author_sort Rey, Amayelle
collection PubMed
description BACKGROUND: For patients with recurrent flares of gout, tophi, urate crystal arthropathy, and renal stones, urate-lowering therapies (ULTs, including allopurinol and febuxostat) are the first-line treatment. Due to the widespread use of these ULTs (especially in patients with impaired renal function), assessment of the associated renal risk is essential. Accordingly, we performed a disproportionality analysis of reported cases of acute renal failure (ARF) associated with allopurinol and febuxostat. METHODS: We carried out a case/non-case study of the World Health Organization’s VigiBase® pharmacovigilance database between January 1, 2008, and December 31, 2018. The frequency of reports of ARF as a standardized Medical Dictionary for Regulatory Activities query for allopurinol and febuxostat was compared with that of all other reports for the two drugs and quoted as the reporting odds ratio (ROR) [95% confidence interval (CI)]. The results’ stability was assessed in a series of sensitivity analyses (notably after the exclusion of putative competing drugs). RESULTS: Among 3509 “suspected drug” notifications for febuxostat and 18,730 for allopurinol, we identified respectively 317 and 1008 cases of ARF. Acute renal failure was reported significantly more frequently for febuxostat and allopurinol than for other drugs (ROR [95%CI] 5.67 [5.05–6.36] and 3.25 [3.05–3.47], respectively). For both drugs, the ROR was higher in women than in men, respectively 11.60 [9.74–13.82] vs. 3.14 [2.69–3.67] for febuxostat and 4.45 [4.04–4.91] vs. 2.29 [2.11–2.50] for allopurinol. The sensitivity analyses confirmed the disproportionality for these two ULTs. CONCLUSIONS: Acute renal failure was reported respectively 5.7 and 3.3 times more frequently for febuxostat and for allopurinol than for other drugs. Due to the potential consequences of ARF, physicians should take account of this disproportionality signal when prescribing the ULTs febuxostat and allopurinol.
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spelling pubmed-68422682019-11-14 Acute kidney injury associated with febuxostat and allopurinol: a post-marketing study Rey, Amayelle Batteux, Benjamin Laville, Solène M. Marienne, Justine Masmoudi, Kamel Gras-Champel, Valérie Liabeuf, Sophie Arthritis Res Ther Research Article BACKGROUND: For patients with recurrent flares of gout, tophi, urate crystal arthropathy, and renal stones, urate-lowering therapies (ULTs, including allopurinol and febuxostat) are the first-line treatment. Due to the widespread use of these ULTs (especially in patients with impaired renal function), assessment of the associated renal risk is essential. Accordingly, we performed a disproportionality analysis of reported cases of acute renal failure (ARF) associated with allopurinol and febuxostat. METHODS: We carried out a case/non-case study of the World Health Organization’s VigiBase® pharmacovigilance database between January 1, 2008, and December 31, 2018. The frequency of reports of ARF as a standardized Medical Dictionary for Regulatory Activities query for allopurinol and febuxostat was compared with that of all other reports for the two drugs and quoted as the reporting odds ratio (ROR) [95% confidence interval (CI)]. The results’ stability was assessed in a series of sensitivity analyses (notably after the exclusion of putative competing drugs). RESULTS: Among 3509 “suspected drug” notifications for febuxostat and 18,730 for allopurinol, we identified respectively 317 and 1008 cases of ARF. Acute renal failure was reported significantly more frequently for febuxostat and allopurinol than for other drugs (ROR [95%CI] 5.67 [5.05–6.36] and 3.25 [3.05–3.47], respectively). For both drugs, the ROR was higher in women than in men, respectively 11.60 [9.74–13.82] vs. 3.14 [2.69–3.67] for febuxostat and 4.45 [4.04–4.91] vs. 2.29 [2.11–2.50] for allopurinol. The sensitivity analyses confirmed the disproportionality for these two ULTs. CONCLUSIONS: Acute renal failure was reported respectively 5.7 and 3.3 times more frequently for febuxostat and for allopurinol than for other drugs. Due to the potential consequences of ARF, physicians should take account of this disproportionality signal when prescribing the ULTs febuxostat and allopurinol. BioMed Central 2019-11-08 2019 /pmc/articles/PMC6842268/ /pubmed/31703711 http://dx.doi.org/10.1186/s13075-019-2011-y Text en © The Author(s). 2019 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. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Rey, Amayelle
Batteux, Benjamin
Laville, Solène M.
Marienne, Justine
Masmoudi, Kamel
Gras-Champel, Valérie
Liabeuf, Sophie
Acute kidney injury associated with febuxostat and allopurinol: a post-marketing study
title Acute kidney injury associated with febuxostat and allopurinol: a post-marketing study
title_full Acute kidney injury associated with febuxostat and allopurinol: a post-marketing study
title_fullStr Acute kidney injury associated with febuxostat and allopurinol: a post-marketing study
title_full_unstemmed Acute kidney injury associated with febuxostat and allopurinol: a post-marketing study
title_short Acute kidney injury associated with febuxostat and allopurinol: a post-marketing study
title_sort acute kidney injury associated with febuxostat and allopurinol: a post-marketing study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6842268/
https://www.ncbi.nlm.nih.gov/pubmed/31703711
http://dx.doi.org/10.1186/s13075-019-2011-y
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