Key result
Macrolide-associated torsadogenic risk was categorized into 4 mutually exclusive groups of events (TdP, QT abnormalities, ventricular arrhythmia, and sudden cardiac death) by an expert panel.
Why the study?
Do macrolides increase torsadogenic risk as reported in the FDA Pharmacovigilance Database?
Observational
Do macrolides increase torsadogenic risk as reported in the FDA Pharmacovigilance Database?
A multidisciplinary panel established a standardized case definition for drug-induced TdP to evaluate the torsadogenic risk of macrolides using the FDA pharmacovigilance database.
Panel categorization enables standardized macrolide torsadogenic assessment in FDA data; leaves open causal TdP risk.
Case definitionTaking into account the multifaceted clinical presentation of TdP, a multidisciplinary panel of experts (i.e., cardiology, pharmacoepidemiology and pharmacovigilance reached consensus on definition of drug-induced TdP, by identifying 4 groups of events reflecting a decreasing order of drug-attributable risk: 1) TdP; 2) QT interval abnormalities (including QT prolongation and shortening); 3) ventricular arrhythmia (VA, including ventricular fibrillation/ tachycardia); 4) Sudden Cardiac Death (SCD).These groups were mutually exclusive (i.e. a single case report of arrhythmias was classified
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Emanuel Raschi Elisabetta Poluzzi (2013) conducted an observational in Torsades de Pointes (TdP). Macrolides was evaluated on Drug-induced TdP. Macrolide-associated torsadogenic risk was categorized into 4 mutually exclusive groups of events (TdP, QT abnormalities, ventricular arrhythmia, and sudden cardiac death) by an expert panel.
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