Evidence map›Paper›PMID 33230596›Full record

ArticleEuropean journal of clinical pharmacology2021

Arrhythmias related to antipsychotics and antidepressants: an analysis of the summaries of product characteristics of original products approved in Germany.

Mohamed Elsayed, Emaad Abdel-Kahaar, Maximilian Gahr, Bernhard J Connemann, Michael Denkinger, Carlos Schönfeldt-Lecuona

Open access · hybridAbstract read
In one paragraph

Article in European journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 20% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 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

6 authors at 3 institutions in 2 countries.

Mohamed ElsayedDepartment of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg 12-14, 89075, Ulm, Germany. mohamed.elsayed@uni-ulm.de.ORCID http://orcid.org/0000-0002-0011-7837
Emaad Abdel-KahaarInstitute of Pharmacology of Natural Products and Clinical Pharmacology, University of Ulm, Ulm, Germany.
Maximilian GahrDepartment of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg 12-14, 89075, Ulm, Germany.
Bernhard J ConnemannDepartment of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg 12-14, 89075, Ulm, Germany.
Michael DenkingerAgaplesion Bethesda Clinic, Geriatric Research Unit Ulm University, Ulm, Germany.
Carlos Schönfeldt-LecuonaDepartment of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg 12-14, 89075, Ulm, Germany.
Universität Ulm · DEAgaplesion Bethesda Klinik · DESouth Valley University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeMost psychiatric drugs, such as antidepressants (AD) and antipsychotics (AP), may cause cardiac adverse events (CAE). We used summaries of product characteristics (SmPC) for assessing the likelihood of AD and AP to cause CAE.

methodsWe identified all original medicinal products (OMP) of AD and AP approved in Germany. We searched for their SmPCs using the online services of PharmaNet.Bund, Gelbe liste®, Rote Liste®, Fachinfo-Service®, and via manufacturer contact. We extracted frequencies of reported CAE (QT prolongation, Torsade de Pointes tachycardia, and ventricular arrhythmia) and performed a risk assessment.

resultsWe obtained the SmPCs of 24 AD and 26 AP identified as OMP. Comparably high reported frequencies regarding QT prolongation were found for Invega® (paliperidone), Serdolect® (sertindole) (≥ 1/100 and < 1/10), and Zoloft® (sertraline) (≥ 1/10.000 and < 1/1000); regarding Torsade de Pointes tachycardia were found for Serdolect® (≥ 1/1000 to < 1/100), Zoloft®, and Trevilor® (venlafaxine) (≥ 1/10.000 and < 1/1000); regarding ventricular tachycardia for Solian® (amisulpride), Xomolix® (droperidol), Zyprexa® (olanzapine), and Trevilor® (≥ 1/10.000 and < 1/1000).

conclusionThe risk and frequency of CAE, as reported in the SmPCs, varied significantly among substances and between groups. There are more reports for AP than AD. The AP with the most frequently reported CAE (QT prolongation and Torsade de Pointes tachycardia) was Serdolect®; for AD, Zoloft® (QT prolongation, Torsade de Pointes tachycardia) and Trevilor® (Torsade de Pointes tachycardia and ventricular tachycardia) carried a higher cardiac risk.

Indexed as

Antidepressive AgentsAntipsychotic AgentsArrhythmias, CardiacGermanyHumansLong QT SyndromeTachycardia, VentricularTorsades de PointesAntidepressive AgentsAntipsychotic AgentsArrhythmiasPsychiatric drugQTc prolongationSmPCsSudden cardiac death

Identifiers

PMID33230596
PMCPMC8032566
OpenAlexW3106546834

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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.