Evidence map›Paper›PMID 31378084›Full record

ArticleCirculation2019

Androgenic Effects on Ventricular Repolarization: A Translational Study From the International Pharmacovigilance Database to iPSC-Cardiomyocytes.

Joe-Elie Salem, Tao Yang, Javid J Moslehi, Xavier Waintraub, Estelle Gandjbakhch, Anne Bachelot, Francoise Hidden-Lucet, Jean-Sebastien Hulot, Bjorn C Knollmann, Benedicte Lebrun-Vignes and 3 more

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Circulation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03193138 (Cardiotoxicity of Androgenic Agonists and Antagonists in the National French Pharmacovigilance Database and EudraCT Database), which is not on this map. Cited by 47 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 1 pooled it
9.3field-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.

NCT03193138 completednot on this map

Cardiotoxicity of Androgenic Agonists and Antagonists in the National French Pharmacovigilance Database and EudraCT Database

TypeobservationalSponsorGroupe Hospitalier Pitie-SalpetriereRan2017 to 2017Enrolled3,096ConditionsHeart DiseasesArmsHormonal therapies: G03, H01C and L02 in the ATC classification
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 1 synthesis or guideline pooled it, 78 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Electrocardiographic Repolarization Changes Following Orchiectomy: Insights Into QT Interval Prolongation and Clinical Implications.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2026
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  18. Sex differences in heart: from basics to clinics.European journal of medical research · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 2 countries.

Joe-Elie SalemAssitance Publique Hopitaux de Paris, Pitié-Salpêtriére Hospital, Departments of Pharmacology and Cardiology, UNICO-GRECO Cardio-oncology Program, Centre d'investigation clinique-1421, Pharmacovigilance Unit (J-E.S., X.W., E.G., F.H-L., B.L-V., C.F-B.), INSERM, Sorbonne Université, Paris, France.
Tao YangDepartment of Medicine (J-E.S., T.Y., J.J.M., B.C.K., A.M.G., D.M.R.), Vanderbilt University Medical Center, Nashville, TN.
Javid J MoslehiDepartment of Medicine (J-E.S., T.Y., J.J.M., B.C.K., A.M.G., D.M.R.), Vanderbilt University Medical Center, Nashville, TN.
Xavier WaintraubAssitance Publique Hopitaux de Paris, Pitié-Salpêtriére Hospital, Departments of Pharmacology and Cardiology, UNICO-GRECO Cardio-oncology Program, Centre d'investigation clinique-1421, Pharmacovigilance Unit (J-E.S., X.W., E.G., F.H-L., B.L-V., C.F-B.), INSERM, Sorbonne Université, Paris, France.
Estelle GandjbakhchAssitance Publique Hopitaux de Paris, Pitié-Salpêtriére Hospital, Departments of Pharmacology and Cardiology, UNICO-GRECO Cardio-oncology Program, Centre d'investigation clinique-1421, Pharmacovigilance Unit (J-E.S., X.W., E.G., F.H-L., B.L-V., C.F-B.), INSERM, Sorbonne Université, Paris, France.
Anne BachelotIE3M, Department of Endocrinology and Reproductive Medicine, and Centre de Référence des Maladies Endocriniennes Rares de la croissance et Centre des Pathologies gynécologiques Rares (A.B.), INSERM, Sorbonne Université, Paris, France.
Francoise Hidden-LucetAssitance Publique Hopitaux de Paris, Pitié-Salpêtriére Hospital, Departments of Pharmacology and Cardiology, UNICO-GRECO Cardio-oncology Program, Centre d'investigation clinique-1421, Pharmacovigilance Unit (J-E.S., X.W., E.G., F.H-L., B.L-V., C.F-B.), INSERM, Sorbonne Université, Paris, France.
Jean-Sebastien HulotUniversité Paris-Descartes, Sorbonne Paris Cité Paris Cardiovascular Research Center, Institut national de la santé et de la recherche médicale UMRS 970, Hôpital Européen Georges Pompidou, AP-HP, Paris, France (J-S-.H.).
Bjorn C KnollmannDepartment of Medicine (J-E.S., T.Y., J.J.M., B.C.K., A.M.G., D.M.R.), Vanderbilt University Medical Center, Nashville, TN.
Benedicte Lebrun-VignesAssitance Publique Hopitaux de Paris, Pitié-Salpêtriére Hospital, Departments of Pharmacology and Cardiology, UNICO-GRECO Cardio-oncology Program, Centre d'investigation clinique-1421, Pharmacovigilance Unit (J-E.S., X.W., E.G., F.H-L., B.L-V., C.F-B.), INSERM, Sorbonne Université, Paris, France.
Christian Funck-BrentanoAssitance Publique Hopitaux de Paris, Pitié-Salpêtriére Hospital, Departments of Pharmacology and Cardiology, UNICO-GRECO Cardio-oncology Program, Centre d'investigation clinique-1421, Pharmacovigilance Unit (J-E.S., X.W., E.G., F.H-L., B.L-V., C.F-B.), INSERM, Sorbonne Université, Paris, France.
Andrew M GlazerDepartment of Medicine (J-E.S., T.Y., J.J.M., B.C.K., A.M.G., D.M.R.), Vanderbilt University Medical Center, Nashville, TN.
Dan M RodenDepartment of Medicine (J-E.S., T.Y., J.J.M., B.C.K., A.M.G., D.M.R.), Vanderbilt University Medical Center, Nashville, TN.
Inserm · FRVanderbilt University Medical Center · USDélégation Paris 5 · FR

Funding

Understanding and preventing HLA-associated drug reactionsP50GM115305 · NIGMS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI PHILLIPS, ELIZABETH · 2015 to 2019
$13.0M
Toward a Mechanism-Based Approach to Treating Cardiac ArrhythmiaR35HL144980 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI KNOLLMANN, BJORN C · 2019 to 2025
$7.1M
Novel mechanisms and predictors of VEGF receptor inhibitor-associated hypertensionR56HL141466 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI MOSLEHI, JAVID J · 2018 to 2018
$613k
NHLBI NIH HHS R35 HL144980NHLBI NIH HHS R56 HL141466NIGMS NIH HHS P50 GM115305
6 · The paper itself

Abstract

backgroundMale hypogonadism, arising from a range of etiologies including androgen-deprivation therapies (ADTs), has been reported as a risk factor for acquired long-QT syndrome (aLQTS) and torsades de pointes (TdP). A full description of the clinical features of aLQTS associated with ADT and of underlying mechanisms is lacking.

methodsWe searched the international pharmacovigilance database VigiBase for men (n=6 560 565 individual case safety reports) presenting with aLQTS, TdP, or sudden death associated with ADT. In cardiomyocytes derived from induced pluripotent stem cells from men, we studied electrophysiological effects of ADT and dihydrotestosterone.

resultsAmong subjects receiving ADT in VigiBase, we identified 184 cases of aLQTS (n=168) and/or TdP (n=68; 11% fatal), and 99 with sudden death. Of the 10 ADT drugs examined, 7 had a disproportional association (reporting odds ratio=1.4-4.7;

conclusionsQT prolongation and TdP are a risk in men receiving enzalutamide and other ADTs. CLINICAL

trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT03193138.

Indexed as

AndrogensAntineoplastic AgentsBenzamidesCell DifferentiationCells, CulturedDatabases, FactualHumansHypogonadismInduced Pluripotent Stem CellsInternational CooperationLong QT SyndromeMaleMyocytes, CardiacNitrilesPharmacovigilancePhenylthiohydantoinAndrogensAntineoplastic AgentsBenzamidesenzalutamideNitrilesPhenylthiohydantoinandrogen antagonistshypogonadismlong QT syndrometestosteronetorsades de pointes

Identifiers

PMID31378084
PMCPMC6756939
OpenAlexW2975521664

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.