Evidence map›Paper›PMID 23325533›Full record

ArticleDrug safety2013

Transplantation for acute liver failure in patients exposed to NSAIDs or paracetamol (acetaminophen): the multinational case-population SALT study.

Sinem Ezgi Gulmez, Dominique Larrey, Georges-Philippe Pageaux, Severine Lignot, Régis Lassalle, Jérémy Jové, Angelo Gatta, P Aiden McCormick, Harold J Metselaar, Estela Monteiro and 15 more

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in Drug safety, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 5 pooled it
20.5field-weighted citation impact, top 1% 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

32 citing papers in PubMed, 5 syntheses or guidelines pooled it, 102 citations in OpenAlex.

  1. Pooled it
  2. Oral paracetamol (acetaminophen) for cancer pain.The Cochrane database of systematic reviews · 2017
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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

25 authors at 12 institutions in 7 countries.

Sinem Ezgi GulmezINSERM CIC-P0005 Pharmaco-épidémiologie, INSERM U657, Service de Pharmacologie, Université Bordeaux Segalen, Bâtiment Le Tondu, Case 41, 146, Rue Léo Saignat, 33076 Bordeaux Cedex, France. sinemezgi.gulmez@u-bordeaux2.fr
Dominique Larrey
Georges-Philippe Pageaux
Severine Lignot
Régis Lassalle
Jérémy Jové
Angelo Gatta
P Aiden McCormick
Harold J Metselaar
Estela Monteiro
Douglas Thorburn
William Bernal
Irene Zouboulis-Vafiadis
Corinne de Vries
Susana Perez-Gutthann
Miriam Sturkenboom
Jacques Bénichou
Jean-Louis Montastruc
Yves Horsmans
Francesco Salvo
Fatima Hamoud
Sophie Micon
Cécile Droz-Perroteau
Patrick Blin
Nicholas Moore
Université de Bordeaux · FRErasmus University Rotterdam · NLInserm · FRUniversité de Montpellier · FRAthens University of Economics and Business · GRKing's College Hospital NHS Foundation Trust · GBSt. Vincent's University Hospital · IEThe Royal Free Hospital · GBUCLouvain · BEUniversité de Toulouse · FRUniversity of Bath · GBUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost NSAIDs are thought to be able to cause hepatic injury and acute liver failure (ALF), but the event rates of those leading to transplantation (ALFT) remain uncertain.

objectivesThe aim of the study was to estimate population event rates for NSAID-associated ALFT

methodsThis was a case-population study of ALFT in 57 eligible liver transplant centres in seven countries (France, Greece, Ireland, Italy, The Netherlands, Portugal and the UK). Cases were all adults registered from 2005 to 2007 for a liver transplant following ALFT without identified clinical aetiology, exposed to an NSAID or paracetamol (acetaminophen) within 30 days before the onset of clinical symptoms. NSAID and paracetamol population exposures were assessed using national sales data from Intercontinental Marketing Services (IMS). Risk was estimated as the rate of ALFT per million treatment-years (MTY).

resultsIn the 52 participating centres, 9479 patients were registered for transplantation, with 600 for ALFT, 301 of whom, without clinical aetiology, had been exposed to a drug within 30 days. Of these 301 patients, 40 had been exposed to an NSAID and 192 to paracetamol (81 of whom were without overdose). Event rates per MTY were 1.59 (95 % CI 1.1-2.2) for all NSAIDs pooled, 2.3 (95 % CI 1.2-3.9) for ibuprofen, 1.9 (95 % CI 0.8-3.7) for nimesulide, 1.6 (95 % CI 0.6-3.4) for diclofenac and 1.6 (95 % CI 0.3-4.5) for ketoprofen. For paracetamol, the event rate was 3.3 per MTY (95 % CI 2.6-4.1) without overdoses and 7.8 (95 % CI 6.8-9.0) including overdoses.

conclusionsALF leading to registration for transplantation after exposure to an NSAID was rare, with no major difference between NSAID. Non-overdose paracetamol-exposed liver failure was twice more common than NSAID-exposed liver failure.

Indexed as

Liver TransplantationAcetaminophenAdultAnalgesics, Non-NarcoticAnti-Inflammatory Agents, Non-SteroidalChemical and Drug Induced Liver InjuryFemaleHumansMaleAcetaminophenAnalgesics, Non-NarcoticAnti-Inflammatory Agents, Non-Steroidal

Identifiers

PMID23325533
PMCPMC3568201
OpenAlexW2064946517

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.