Evidence map›Paper›PMID 29042382›Full record

ArticleBMJ open2017

Drugs and life-threatening ventricular arrhythmia risk: results from the DARE study cohort.

Abigail L Coughtrie, Elijah R Behr, Deborah Layton, Vanessa Marshall, A John Camm, Saad A W Shakir

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05418036 (Safety Assessment for Sotalol Protocol in Outpatient Unit), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
4.3field-weighted citation impact, top 4% 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.

NCT05418036 phase4unknown statusnot on this mapstarted 2020, after this paper: background citation

Safety Assessment for Sotalol Protocol in Outpatient Unit

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2020 to 2023Enrolled110ConditionsSupraventricular Arrhythmia, Ventricular Arrythmia, Proarrhythmia, Antiarrhythmic Drug Adverse ReactionArmsSotalol Oral Tablet
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 40 citations in OpenAlex.

  1. Article
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  5. Sex- and age-specific differences in the use of antiarrhythmic therapies among atrial fibrillation patients: a nationwide cohort study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024
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  7. Racial, ethnic, and sex disparities in atrial fibrillation management: rate and rhythm control.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2023
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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

6 authors at 3 institutions in 1 country.

Abigail L CoughtrieResearch Department, Drug Safety Research Unit, Southampton, UK.
Elijah R BehrCardiology Clinical Academic Group, St George's University of London, London, UK.
Deborah LaytonResearch Department, Drug Safety Research Unit, Southampton, UK.
Vanessa MarshallResearch Department, Drug Safety Research Unit, Southampton, UK.
A John CammCardiology Clinical Academic Group, St George's University of London, London, UK.
Saad A W ShakirResearch Department, Drug Safety Research Unit, Southampton, UK.
Drug Safety Research Unit · GBSt George's, University of London · GBUniversity of Portsmouth · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo establish a unique sample of proarrhythmia cases, determine the characteristics of cases and estimate the contribution of individual drugs to the incidence of proarrhythmia within these cases.

settingSuspected proarrhythmia cases were referred by cardiologists across England between 2003 and 2011. Information on demography, symptoms, prior medical and drug histories and data from hospital notes were collected.

participantsTwo expert cardiologists reviewed data for 293 referred cases: 130 were included. Inclusion criteria were new onset or exacerbation of pre-existing ventricular arrhythmias, QTc >500 ms, QTc >450 ms (men) or >470 ms (women) with cardiac syncope, all secondary to drug administration. Exclusion criteria were acute ischaemia and ischaemic polymorphic ventricular tachycardia at presentation, structural heart disease, consent withdrawn or deceased prior to study. Descriptive analysis of Caucasian cases (95% of included cases, n=124) and culpable drug exposures was performed.

resultsOf the 124 Caucasian cases, 95 (77%) were QTc interval prolongation-related; mean age was 62 years (SD 15), and 63% were female. Cardiovascular comorbidities included hypertension (53%) and patient-reported 'heart rhythm problems' (73%). Family history of sudden death (36%) and hypokalaemia at presentation (27%) were common. 165 culpable drug exposures were reported, including antiarrhythmics (42%), of which amiodarone and flecainide were the most common. Sotalol, a beta-blocking agent with antiarrhythmic activity, was also common (15%). 26% reported multiple drugs, of which 84% reported at least one cytochrome (CYP) P450 inhibitor. Potential pharmacodynamics interactions identified were mainly QT prolongation (59%).

conclusionsAntiarrhythmics, non-cardiac drugs and drug combinations were found to be culpable in a large cohort of 124 clinically validated proarrhythmia cases. Potential clinical factors that may warn the prescriber of potential proarrhythmia include older women, underlying cardiovascular comorbidity, family history of sudden death and hypokalaemia.

Indexed as

AdolescentAdrenergic beta-AntagonistsAdultAgedAged, 80 and overAnti-Arrhythmia AgentsAntipsychotic AgentsArrhythmias, CardiacChildCohort StudiesComorbidityDeath, SuddenDrug-Related Side Effects and Adverse ReactionsElectrocardiographyEnglandFemaleAdrenergic beta-AntagonistsAnti-Arrhythmia AgentsAntipsychotic AgentsepidemiologyproarrhythmiaQT interval prolongation

Identifiers

PMID29042382
PMCPMC5652462
OpenAlexW2765440311

What OpenQuestion holds

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LicenceCC BY-NC
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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.