Open-access database of literature derived drug-related Torsade de Pointes cases
Abstract Since an introduction of an ICH guidance in 2005, no new drugs were withdrawn from the market because of the causation of Torsade de Pointes (TdP). However, the risk of TdP is still a concern for marketed drugs. TdP is a type of polymorphic ventricular tachycardia which may lead to sudden c...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-01-01
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| Series: | BMC Pharmacology and Toxicology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40360-021-00548-0 |
| _version_ | 1798026518657499136 |
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| author | Krumpholz Laura Wiśniowska Barbara Polak Sebastian |
| author_facet | Krumpholz Laura Wiśniowska Barbara Polak Sebastian |
| author_sort | Krumpholz Laura |
| collection | DOAJ |
| description | Abstract Since an introduction of an ICH guidance in 2005, no new drugs were withdrawn from the market because of the causation of Torsade de Pointes (TdP). However, the risk of TdP is still a concern for marketed drugs. TdP is a type of polymorphic ventricular tachycardia which may lead to sudden cardiac death. QT/QTc interval prolongation is considered a sensitive, but not specific biomarker. To improve the effectiveness of studies’ workflow related to TdP risk prediction we created an extensive, structured, open-access database of drug-related TdP cases. PubMed, Google Scholar bibliographic databases, and the Internet, via the Google search engine, were searched to identify eligible reports. A total of 424 papers with a description of 634 case reports and observational studies were included. Each paper was manually examined and listed with up to 53 variables related to patient/population characteristics, general health parameters, used drugs, laboratory measurements, ECG results, clinical management, and its outcomes, as well as suspected drug’s properties and its FDA adverse reaction reports. The presented database may be considered as an extension of the recently developed and published database of drug cardiac safety-related information, part of the tox-portal project providing resources for cardiac toxicity assessment. |
| first_indexed | 2024-04-11T18:37:46Z |
| format | Article |
| id | doaj.art-9bb7d543a97d4db7b467b80bb1c4d8d3 |
| institution | Directory Open Access Journal |
| issn | 2050-6511 |
| language | English |
| last_indexed | 2024-04-11T18:37:46Z |
| publishDate | 2022-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pharmacology and Toxicology |
| spelling | doaj.art-9bb7d543a97d4db7b467b80bb1c4d8d32022-12-22T04:09:13ZengBMCBMC Pharmacology and Toxicology2050-65112022-01-012311410.1186/s40360-021-00548-0Open-access database of literature derived drug-related Torsade de Pointes casesKrumpholz Laura0Wiśniowska Barbara1Polak Sebastian2Pharmacoepidemiology and Farmacoeconomics Unit, Faculty of Pharmacy, Jagiellonian University Medical CollegePharmacoepidemiology and Farmacoeconomics Unit, Faculty of Pharmacy, Jagiellonian University Medical CollegePharmacoepidemiology and Farmacoeconomics Unit, Faculty of Pharmacy, Jagiellonian University Medical CollegeAbstract Since an introduction of an ICH guidance in 2005, no new drugs were withdrawn from the market because of the causation of Torsade de Pointes (TdP). However, the risk of TdP is still a concern for marketed drugs. TdP is a type of polymorphic ventricular tachycardia which may lead to sudden cardiac death. QT/QTc interval prolongation is considered a sensitive, but not specific biomarker. To improve the effectiveness of studies’ workflow related to TdP risk prediction we created an extensive, structured, open-access database of drug-related TdP cases. PubMed, Google Scholar bibliographic databases, and the Internet, via the Google search engine, were searched to identify eligible reports. A total of 424 papers with a description of 634 case reports and observational studies were included. Each paper was manually examined and listed with up to 53 variables related to patient/population characteristics, general health parameters, used drugs, laboratory measurements, ECG results, clinical management, and its outcomes, as well as suspected drug’s properties and its FDA adverse reaction reports. The presented database may be considered as an extension of the recently developed and published database of drug cardiac safety-related information, part of the tox-portal project providing resources for cardiac toxicity assessment.https://doi.org/10.1186/s40360-021-00548-0Torsade de PointesTdPDrug-induced TdPProarrhythmic potentialDrug cardiotoxicityDatabase |
| spellingShingle | Krumpholz Laura Wiśniowska Barbara Polak Sebastian Open-access database of literature derived drug-related Torsade de Pointes cases BMC Pharmacology and Toxicology Torsade de Pointes TdP Drug-induced TdP Proarrhythmic potential Drug cardiotoxicity Database |
| title | Open-access database of literature derived drug-related Torsade de Pointes cases |
| title_full | Open-access database of literature derived drug-related Torsade de Pointes cases |
| title_fullStr | Open-access database of literature derived drug-related Torsade de Pointes cases |
| title_full_unstemmed | Open-access database of literature derived drug-related Torsade de Pointes cases |
| title_short | Open-access database of literature derived drug-related Torsade de Pointes cases |
| title_sort | open access database of literature derived drug related torsade de pointes cases |
| topic | Torsade de Pointes TdP Drug-induced TdP Proarrhythmic potential Drug cardiotoxicity Database |
| url | https://doi.org/10.1186/s40360-021-00548-0 |
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