Evidence map›Paper›PMID 33759010›Full record

ArticleArchives of toxicology2021

Serious liver injury induced by Nimesulide: an international collaborative study.

Fernando Bessone, Nelia Hernandez, Manuel Mendizabal, Ezequiel Ridruejo, Gisela Gualano, Eduardo Fassio, Mirta Peralta, Hugo Fainboim, Margarita Anders, Hugo Tanno and 14 more

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In one paragraph

Article in Archives of toxicology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.9field-weighted citation impact, top 16% 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

4 citing papers in PubMed, 16 citations in OpenAlex.

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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

24 authors at 11 institutions in 5 countries.

Fernando BessoneDepartment of Gastroenterology and Hepatology, Hospital Provincial del Centenario, University of Rosario School of Medicine, Urquiza 3101, 200, Rosario, Argentina. bessonefernando@gmail.com.ORCID http://orcid.org/0000-0002-8569-8123
Nelia HernandezFacultad de Medicina, Hospital de Clínicas, Montevideo, Uruguay.
Manuel MendizabalHospital Universitario Austral, Buenos Aires, Argentina.ORCID https://orcid.org/0000-0002-7026-9908
Ezequiel RidruejoCentro de Educación Médica e Investigaciones Clínicas, Buenos Aires, Argentina.ORCID https://orcid.org/0000-0002-3321-0683
Gisela GualanoHospital Alejandro Posadas, Buenos Aires, Argentina.
Eduardo FassioHospital Alejandro Posadas, Buenos Aires, Argentina.
Mirta PeraltaHospital Muñiz, Buenos Aires, Argentina.
Hugo FainboimHospital Muñiz, Buenos Aires, Argentina.
Margarita AndersHospital Alemán, Buenos Aires, Argentina.
Hugo TannoDepartment of Gastroenterology and Hepatology, Hospital Provincial del Centenario, University of Rosario School of Medicine, Urquiza 3101, 200, Rosario, Argentina.
Federico TannoDepartment of Gastroenterology and Hepatology, Hospital Provincial del Centenario, University of Rosario School of Medicine, Urquiza 3101, 200, Rosario, Argentina.
Raymundo ParanaFacultad de Medicina, Universidad Nacional de Bahia, Salvador de Bahia, Brazil.
Inmaculada Medina-CalizServicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga-IBIMA, Universidad de Málaga, Málaga, Spain. CIBERehd, Madrid, Spain.ORCID https://orcid.org/0000-0003-0471-6658
Mercedes Robles-DiazServicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga-IBIMA, Universidad de Málaga, Málaga, Spain. CIBERehd, Madrid, Spain.ORCID https://orcid.org/0000-0002-2365-2787
Ismael Alvarez-AlvarezServicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga-IBIMA, Universidad de Málaga, Málaga, Spain. CIBERehd, Madrid, Spain.ORCID https://orcid.org/0000-0001-6271-0604
Hao NiuServicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga-IBIMA, Universidad de Málaga, Málaga, Spain. CIBERehd, Madrid, Spain.ORCID https://orcid.org/0000-0002-3030-3972
Camilla StephensServicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga-IBIMA, Universidad de Málaga, Málaga, Spain. CIBERehd, Madrid, Spain.
Luis ColombatoHospital Británico, Buenos Aires, Argentina.
Marco ArresePontificia Universidad Catolica de Chile, Santiago de Chile, Chile.
M Virginia ReggiardoDepartment of Gastroenterology and Hepatology, Hospital Provincial del Centenario, University of Rosario School of Medicine, Urquiza 3101, 200, Rosario, Argentina.
Suzane Kioko OnoHospital Das Clinicas, Sao Paulo, Brazil.ORCID https://orcid.org/0000-0002-6963-0911
Flair CarrilhoHospital Das Clinicas, Sao Paulo, Brazil.
M Isabel LucenaServicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga-IBIMA, Universidad de Málaga, Málaga, Spain. CIBERehd, Madrid, Spain. lucena@uma.es.ORCID https://orcid.org/0000-0001-9586-4896
Raul J AndradeServicios de Aparato Digestivo y Farmacología Clínica, Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga-IBIMA, Universidad de Málaga, Málaga, Spain. CIBERehd, Madrid, Spain.ORCID https://orcid.org/0000-0002-1565-0757
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas · ESHospital Provincial de Rosario · ARHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRHospital Muñiz · ARHospital Posadas · ARCentro de Educación Médica e Investigaciones Clínicas Norberto Quirno · ARHospital Alemán · ARHospital Británico de Buenos Aires · ARHospital de Clínicas · UYHospital Universitario Austral · ARPontificia Universidad Católica de Chile · CL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Nimesulide is a non-steroidal anti-inflammatory drug still marketed in many countries. We aim to analyze the clinical phenotype, outcome, and histological features of nimesulide-induced liver injury (nimesulide-DILI). We analyzed 57 cases recruited from the Spanish and Latin American DILI registries. Causality was assessed by the RUCAM scale. Mean age of the whole case series was 59 years (86% women) with a median time to onset of 40 days. A total of 46 patients (81%) were jaundiced. Nimesulide-DILI pattern was hepatocellular in 38 (67%), mixed in 12 (21%), and cholestatic in 7 (12%) cases. Transaminases were elevated with a mean of nearly 20-fold the upper limit of normality (ULN), while alkaline phosphatase showed a twofold mean elevation above ULN. Total bilirubin showed a mean elevation of 13-fold the ULN. Liver histology was obtained in 14 cases (25%), most of them with a hepatocellular pattern. Median time to recovery was 60 days. Overall, 12 patients (21%) developed acute liver failure (ALF), five (8.8%) died, three underwent liver transplantation (5.3%), and the remaining four resolved. Latency was ≤ 15 days in 12 patients (21%) and one patient developed ALF within 7 days from treatment initiation. Increased total bilirubin and aspartate transaminase levels were independently associated with the development of ALF. In summary, nimesulide-DILI affects mainly women and presents typically with a hepatocellular pattern. It is associated with ALF and death in a high proportion of patients. Shorter (≤ 15 days) duration of therapy does not prevent serious nimesulide hepatotoxicity, making its risk/benefit ratio clearly unfavorable.

Indexed as

AdolescentAdultAgedAged, 80 and overAnti-Inflammatory Agents, Non-SteroidalBilirubinChemical and Drug Induced Liver InjuryChildCholestasisCohort StudiesFemaleHumansJaundiceLatin AmericaLiver Failure, AcuteMaleAnti-Inflammatory Agents, Non-SteroidalBilirubinnimesulideSulfonamidesAcute liver failureCholestasisHepatitisHepatotoxicityNimesulideNSAID

Identifiers

PMID33759010
OpenAlexW3138506114

What OpenQuestion holds

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Registered trials

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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.