Evidence map›Paper›PMID 15090000›Full record

ReviewJournal of cardiovascular electrophysiology2004

Drug-induced torsades de pointes and implications for drug development.

Robert R Fenichel, Marek Malik, Charles Antzelevitch, Michael Sanguinetti, Dan M Roden, Silvia G Priori, Jeremy N Ruskin, Raymond J Lipicky, Louis R Cantilena, Independent Academic Task Force

Abstract readReview
In one paragraph

Review in Journal of cardiovascular electrophysiology, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 98 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
98citing papers in PubMed, 3 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

98 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  6. Correction for QT/RR hysteresis in the assessment of drug-induced QTc changes--cardiac safety of gadobutrol.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2009
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38 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

10 authors.

Robert R FenichelWashington, DC, USA.
Marek Malik
Charles Antzelevitch
Michael Sanguinetti
Dan M Roden
Silvia G Priori
Jeremy N Ruskin
Raymond J Lipicky
Louis R Cantilena
Independent Academic Task Force

Funding

PHARMACOGENOMICS OF ARRHYTHMIA THERAPYU01HL065962 · NHLBI · VANDERBILT UNIVERSITY · PI RODEN, DAN M · 2001 to 2009
$24.8M
Pharmacogenomics of Arrhythmia TherapyU19HL065962 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI RODEN, DAN M · 2010 to 2014
$17.4M
Transcriptional remodeling in cardiac arrhythmiasP01HL046681 · NHLBI · VANDERBILT UNIVERSITY · PI GEORGE, ALFRED L. · 1992 to 2006
$8.1M
ELECTRICAL HETEROGENEITY AND CARDIAC ARRHYTHMIASR01HL047678 · NHLBI · MASONIC MEDICAL RESEARCH LABORATORY, INC · PI ANTZELEVITCH, CHARLES · 1993 to 2014
$5.7M
MODULATION OF CARDIAC REPOLARIZATIONR01HL049989 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI RODEN, DAN M · 1994 to 2015
$5.2M
NHLBI NIH HHS HL 46681NHLBI NIH HHS HL49989NHLBI NIH HHS HL 65962NHLBI NIH HHS P01 HL046681NHLBI NIH HHS R01 HL047678NHLBI NIH HHS R01 HL049989NHLBI NIH HHS U01 HL065962NHLBI NIH HHS U19 HL065962Wellcome Trust
6 · The paper itself

Abstract

Torsades de pointes is a potentially lethal arrhythmia that occasionally appears as an adverse effect of pharmacotherapy. Recently developed understanding of the underlying electrophysiology allows better estimation of the drug-induced risks and explains the failures of older approaches through the surface ECG. This article expresses a consensus reached by an independent academic task force on the physiologic understanding of drug-induced repolarization changes, their preclinical and clinical evaluation, and the risk-to-benefit interpretation of drug-induced torsades de pointes. The consensus of the task force includes suggestions on how to evaluate the risk of torsades within drug development programs. Individual sections of the text discuss the techniques and limitations of methods directed at drug-related ion channel phenomena, investigations aimed at action potentials changes, preclinical studies of phenomena seen only in the whole (or nearly whole) heart, and interpretation of human ECGs obtained in clinical studies. The final section of the text discusses drug-induced torsades within the larger evaluation of drug-related risks and benefits.

Indexed as

Anti-Arrhythmia AgentsDrugs, InvestigationalElectrocardiographyElectrophysiologyHumansLong QT SyndromeRisk AssessmentTorsades de PointesAnti-Arrhythmia AgentsDrugs, Investigational

Identifiers

PMID15090000
PMCPMC1544371

What OpenQuestion holds

Textmetadata
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.