Evidence map›Paper›PMID 31703711›Full record

ArticleArthritis research & therapy2019

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

Amayelle Rey, Benjamin Batteux, Solène M Laville, Justine Marienne, Kamel Masmoudi, Valérie Gras-Champel, Sophie Liabeuf

Open access · goldAbstract read
In one paragraph

Article in Arthritis research & therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
0.9field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 34 citations in OpenAlex.

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  18. Effects of Tart Cherry Powder on Serum Uric Acid in Hyperuricemia Rat Model.Evidence-based complementary and alternative medicine : eCAM · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Amayelle ReyRegional Pharmacovigilance Centre, Division of Clinical Pharmacology, Amiens University Hospital, Amiens, France.
Benjamin BatteuxRegional Pharmacovigilance Centre, Division of Clinical Pharmacology, Amiens University Hospital, Amiens, France.
Solène M LavilleCESP Centre for Research in Epidemiology and Population Health, Université Paris-Saclay, Université Paris Sud, UVSQ, UMRS 1018, F-94807, Villejuif, France.
Justine MarienneRegional Pharmacovigilance Centre, Division of Clinical Pharmacology, Amiens University Hospital, Amiens, France.
Kamel MasmoudiRegional Pharmacovigilance Centre, Division of Clinical Pharmacology, Amiens University Hospital, Amiens, France.
Valérie Gras-ChampelRegional Pharmacovigilance Centre, Division of Clinical Pharmacology, Amiens University Hospital, Amiens, France.
Sophie LiabeufRegional Pharmacovigilance Centre, Division of Clinical Pharmacology, Amiens University Hospital, Amiens, France. liabeuf.sophie@chu-amiens.fr.ORCID 0000-0001-5384-9006
Centre Hospitalier Universitaire Amiens-Picardie · FRUniversité Paris-Sud · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFor 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.

methodsWe 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).

resultsAmong 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.

conclusionsAcute 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.

Indexed as

PharmacovigilanceAcute Kidney InjuryAdultAgedAllopurinolFebuxostatFemaleGoutGout SuppressantsHumansMaleMiddle AgedProduct Surveillance, PostmarketingTreatment OutcomeAllopurinolFebuxostatGout SuppressantsAcute renal failurePharmacovigilancePost-marketing studyUrate-lowering therapies

Identifiers

PMID31703711
PMCPMC6842268
OpenAlexW2986834870

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.