{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T22:55:30Z","timestamp":1792450530546,"version":"4.5.0"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,1,10]],"date-time":"2022-01-10T00:00:00Z","timestamp":1641772800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,1,10]],"date-time":"2022-01-10T00:00:00Z","timestamp":1641772800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Pharmacol Toxicol"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Since an introduction of an ICH guidance in 2005, no new drugs were withdrawn from the market because of the causation of Torsade de Pointes (TdP).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\u2019 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\u2019s 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.<\/jats:p>","DOI":"10.1186\/s40360-021-00548-0","type":"journal-article","created":{"date-parts":[[2022,1,10]],"date-time":"2022-01-10T14:02:51Z","timestamp":1641823371000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Open-access database of literature derived drug-related Torsade de Pointes cases"],"prefix":"10.1186","volume":"23","author":[{"given":"Laura","family":"Krumpholz","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Wi\u015bniowska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Polak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,1,10]]},"reference":[{"issue":"7","key":"548_CR1","doi-asserted-by":"publisher","first-page":"495","DOI":"10.1038\/d41573-019-00074-z","volume":"18","author":"H Dowden","year":"2019","unstructured":"Dowden H, Munro J. Trends in clinical success rates and therapeutic focus. Nat Rev Drug Discov. 2019;18(7):495\u20136.","journal-title":"Nat Rev Drug Discov"},{"issue":"4","key":"548_CR2","doi-asserted-by":"publisher","first-page":"675","DOI":"10.1111\/j.1476-5381.2011.01255.x","volume":"163","author":"H Laverty","year":"2011","unstructured":"Laverty H, Benson C, Cartwright E, Cross M, Garland C, Hammond T, et al. How can we improve our understanding of cardiovascular safety liabilities to develop safer medicines?: Cardiovascular toxicity of medicines. Br J Pharmacol. 2011;163(4):675\u201393.","journal-title":"Br J Pharmacol"},{"issue":"6","key":"548_CR3","doi-asserted-by":"publisher","first-page":"889","DOI":"10.2217\/14622416.7.6.889","volume":"7","author":"RR Shah","year":"2006","unstructured":"Shah RR. Can pharmacogenetics help rescue drugs withdrawn from the market? Pharmacogenomics. 2006;7(6):889\u2013908.","journal-title":"Pharmacogenomics"},{"key":"548_CR4","unstructured":"ICH E14. 2005. \u201cICH E14. Note for Guidance on The Clinical Evaluation of QT\/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs\u201d."},{"key":"548_CR5","unstructured":"ICH 2005. \u201cGuidance for Industry S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals\u201d."},{"issue":"7","key":"548_CR6","doi-asserted-by":"publisher","first-page":"457","DOI":"10.1038\/nrd.2015.34","volume":"15","author":"G Gintant","year":"2016","unstructured":"Gintant G, Sager PT, Stockbridge N. Evolution of strategies to improve preclinical cardiac safety testing. Nat Rev Drug Discov. 2016;15(7):457\u201371.","journal-title":"Nat Rev Drug Discov"},{"issue":"1","key":"548_CR7","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1177\/1087057115594589","volume":"21","author":"B Fermini","year":"2016","unstructured":"Fermini B, Hancox JC, Abi-Gerges N, Bridgland-Taylor M, Chaudhary KW, Colatsky T, et al. A New Perspective in the Field of Cardiac Safety Testing through the Comprehensive In Vitro Proarrhythmia Assay Paradigm. J Biomol Screen. 2016;21(1):1\u201311.","journal-title":"J Biomol Screen"},{"key":"548_CR8","unstructured":"CredibleMeds. AZCERT. 2014. https:\/\/www.crediblemeds.org\/. Accessed 10 June 2021."},{"issue":"11","key":"548_CR9","doi-asserted-by":"publisher","first-page":"1363","DOI":"10.1136\/heart.89.11.1363","volume":"89","author":"YG Yap","year":"2003","unstructured":"Yap YG. Drug induced QT prolongation and torsades de pointes. 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