Evidence map›Paper›PMID 35013204›Full record

ArticleNature communications2022

Systematic analysis of drug-associated myocarditis reported in the World Health Organization pharmacovigilance database.

Lee S Nguyen, Leslie T Cooper, Mathieu Kerneis, Christian Funck-Brentano, Johanne Silvain, Nicolas Brechot, Guillaume Hekimian, Enrico Ammirati, Badr Ben M'Barek, Alban Redheuil and 7 more

Abstract read
In one paragraph

Article in Nature communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 73 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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

73 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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13 more citing papers are in PubMed but not listed here.

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

17 authors.

Lee S NguyenCMC Ambroise Paré, Research & Innovation (RICAP), Neuilly-sur-Seine, France. nguyen.lee@icloud.com.ORCID 0000-0002-6014-6269
Leslie T CooperDepartment of Cardiovascular Medicine, Mayo Clinic, Jacksonville, Florida, USA.
Mathieu KerneisSorbonne Université, ACTION Study Group, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), INSERM UMRS 1166, Paris, France.
Christian Funck-BrentanoDepartment of Pharmacology, Sorbonne University, INSERM CIC Paris-Est, AP-HP, ICAN, Regional Pharmacovigilance Centre, Pitié-Salpêtrière Hospital, F-75013, Paris, France.ORCID 0000-0003-0406-5189
Johanne SilvainSorbonne Université, ACTION Study Group, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), INSERM UMRS 1166, Paris, France.
Nicolas BrechotDepartment of Critical Care Medicine, AP-HP, Sorbonne Université, Pitié-Salpêtrière, Paris, France.
Guillaume HekimianDepartment of Critical Care Medicine, AP-HP, Sorbonne Université, Pitié-Salpêtrière, Paris, France.
Enrico Ammirati"De Gasperis" Cardio Center and Transplant Center, Niguarda Hospital, Milan, Italy.
Badr Ben M'BarekCMC Ambroise Paré, Research & Innovation (RICAP), Neuilly-sur-Seine, France.
Alban RedheuilDepartment of Cardiovascular Imagery, AP-HP, Sorbonne Université, Pitié-Salpêtrière, Paris, France.
Estelle GandjbakhchSorbonne Université, ACTION Study Group, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), INSERM UMRS 1166, Paris, France.
Kevin BihanDepartment of Pharmacology, Sorbonne University, INSERM CIC Paris-Est, AP-HP, ICAN, Regional Pharmacovigilance Centre, Pitié-Salpêtrière Hospital, F-75013, Paris, France.ORCID 0000-0001-6797-0237
Bénédicte Lebrun-VignesDepartment of Pharmacology, Sorbonne University, INSERM CIC Paris-Est, AP-HP, ICAN, Regional Pharmacovigilance Centre, Pitié-Salpêtrière Hospital, F-75013, Paris, France.
Stephane EderhyDepartment of Cardiology, AP-HP, Sorbonne Université, Pitié-Salpêtrière, Paris, France.
Charles Dolladille *Department of Pharmacology, CHU de Caen, Caen, F-14000, France.
Javid J Moslehi *Departments of Medicine and Pharmacology, Cardio-oncology Program, Vanderbilt University Medical Center, Nashville, TN, USA.
Joe-Elie SalemDepartment of Pharmacology, Sorbonne University, INSERM CIC Paris-Est, AP-HP, ICAN, Regional Pharmacovigilance Centre, Pitié-Salpêtrière Hospital, F-75013, Paris, France. joe-elie.salem@aphp.fr.ORCID 0000-0002-0331-3307

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

While multiple pharmacological drugs have been associated with myocarditis, temporal trends and overall mortality have not been reported. Here we report the spectrum and main features of 5108 reports of drug-induced myocarditis, in a worldwide pharmacovigilance analysis, comprising more than 21 million individual-case-safety reports from 1967 to 2020. Significant association between myocarditis and a suspected drug is assessed using disproportionality analyses, which use Bayesian information component estimates. Overall, we identify 62 drugs associated with myocarditis, 41 of which are categorized into 5 main pharmacological classes: antipsychotics (n = 3108 reports), salicylates (n = 340), antineoplastic-cytotoxics (n = 190), antineoplastic-immunotherapies (n = 538), and vaccines (n = 790). Thirty-eight (61.3%) drugs were not previously reported associated with myocarditis. Antipsychotic was the first (1979) and most reported class (n = 3018). In 2019, the two most reported classes were antipsychotics (54.7%) and immunotherapies (29.5%). Time-to-onset between treatment start and myocarditis is 15 [interquartile range: 10; 23] days. Subsequent mortality is 10.3% and differs between drug classes with immunotherapies the highest, 32.5% and salicylates the lowest, 2.6%. These elements highlight the diversity of presentations of myocarditis depending on drug class, and show the emerging role of antineoplastic drugs in the field of drug-induced myocarditis.

Indexed as

Pharmaceutical PreparationsPharmacovigilanceSystems AnalysisAdverse Drug Reaction Reporting SystemsAntineoplastic AgentsAntipsychotic AgentsBayes TheoremCross-Sectional StudiesDatabases, FactualData ManagementHumansImmunotherapyMyocarditisWorld Health OrganizationAntineoplastic AgentsAntipsychotic AgentsPharmaceutical Preparations

Identifiers

PMID35013204
PMCPMC8748719

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.