Open-access database of literature derived drug-related Torsade de Pointes cases

Krumpholz, Laura; Wiśniowska, Barbara; Polak, Sebastian

doi:10.1186/s40360-021-00548-0

Cited by 7 publications

(4 citation statements)

References 20 publications

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“…Previous studies have found multiple risk factors for TdP, including female, age (≥65 years), etc. ( 26 – 28 ), which was also observed in our study. Sex-related differences in TdP are increasingly recognized, but the mechanisms remain uncertain.…”

Section: Discussionsupporting

confidence: 91%

Drug-induced torsades de pointes: Disproportionality analysis of the United States Food and Drug Administration adverse event reporting system

Zhou

et al. 2022

Front. Cardiovasc. Med.

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ObjectiveThis study aimed to identify the most common and top drugs associated with the risk of torsades de pointes (TdP) based on the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.Materials and methodsWe used OpenVigil 2.1 to query FAERS database and data from the first quarter of 2004 to the third quarter of 2021 were retrieved. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify TdP cases. We listed the most common drugs associated with the reported TdP cases. Then, the reporting odds ratio (ROR) and the proportional reporting ratio (PRR) for the reporting association between different drugs and TdP risk were calculated. Meanwhile, comparisons were conducted with the QT drug lists of CredibleMeds® in an attempt to identify drugs with a potential risk of TdP that were not on the list.ResultsA total of 9,217,181 adverse event reports were identified, of which 3,807 (0.04%) were related to TdP. TdP was more likely to occur in the elderly and females. Amiodarone (464 cases) was associated with most cases of TdP. According to the disproportionality analysis, the top five drugs with the highest ROR and PRR were tolazoline (ROR 1615.11, 95% confidence interval [CI] 455.59–5725.75, PRR 969.46, χ2 2960.10), levomethadyl (ROR 1211.01, 95% CI 302.75–4844.04, PRR 807.67, χ2 1677.03), ibutilide (ROR 1118.74, 95% CI 425.00–2944.91, PRR 765.77, χ2 3845.27), halofantrine (ROR 660.55, 95% CI 184.21–2368.69, PRR 519.22, χ2 1076.31), and isoproterenol (ROR 352.20, 95% CI 227.19–546.00, PRR 307.82, χ2 6692.53). Approximately half of the top 50 drugs (22 for ROR, 30 for PRR) were not outlined on the QT drug lists of CredibleMeds®.ConclusionApproximately half of the top risk drugs (22 for ROR, 30 for PRR) were not outlined in the QT drug lists of CredibleMeds®. Notably, potential risks are of great importance and should be closely monitored in clinical practice. Also, further research is needed to investigate the association between these drugs and TdP.

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Section: Discussionsupporting

confidence: 91%

Drug-induced torsades de pointes: Disproportionality analysis of the United States Food and Drug Administration adverse event reporting system

Zhou

et al. 2022

Front. Cardiovasc. Med.

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“…An off‐target effect on the hERG potassium channel was identified as the most common mechanism associated with delayed cardiac repolarization. Reported cases of torsade de pointes are almost exclusively associated with small molecules known to directly or indirectly block hERG potassium channels 1 . Therefore, evaluation of new molecule hERG blockade potential is an important component of arrhythmogenic liability assessment.…”

Section: Historic Off‐target Herg Liability Of Small Moleculesmentioning

confidence: 99%

“…Reported cases of torsade de pointes are almost exclusively associated with small molecules known to directly or indirectly block hERG potassium channels. 1 Therefore, evaluation of new molecule hERG blockade potential is an important component of arrhythmogenic liability assessment.…”

mentioning

confidence: 99%

The Efficacy, Effectiveness, and Efficiency of Integrated QTc Assessment: Rationalizing Approaches to New Drug Modalities

Abernathy,

Leishman

2024

Clin Pharma and Therapeutics

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After nearly 3 decades of regulatory activity concerning new drugs' potential for delayed cardiac repolarization an integrated risk assessment paradigm for small molecule drugs has been established. Regulatory guidance also suggests that for large, targeted proteins and monoclonal antibodies no quantitative clinical QTc assessment is necessary. The expansion of new drug modalities prompts the question: “Should these new modalities be treated like small molecule drugs or like monoclonal antibodies?”

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“…Following publication of the original article [ 1 ], the authors identified an error in the authors names. The given names and family names were erroneously transposed.…”

mentioning

confidence: 99%

Correction to: Open-access database of literature derived drug-related Torsade de Pointes cases

Krumpholz

Wiśniowska

Polak

2022

BMC Pharmacol Toxicol

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Open-access database of literature derived drug-related Torsade de Pointes cases

Cited by 7 publications

References 20 publications

Drug-induced torsades de pointes: Disproportionality analysis of the United States Food and Drug Administration adverse event reporting system

Drug-induced torsades de pointes: Disproportionality analysis of the United States Food and Drug Administration adverse event reporting system

The Efficacy, Effectiveness, and Efficiency of Integrated QTc Assessment: Rationalizing Approaches to New Drug Modalities

Correction to: Open-access database of literature derived drug-related Torsade de Pointes cases

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