Torsade de Pointes and QT Prolongation Among Antifungal Triazoles: A Real-World, Retrospective, Observational, Pharmacovigilance Analysis of the FDA Adverse Event Reporting System (FAERS) Database
Abstract
The widespread use of antifungal triazoles has increasingly been associated with cardiovascular adverse events (AEs), particularly torsade de pointes (TdP) and QT prolongation. Understanding the characteristics of TdP/QT prolongation associated with antifungal triazoles is crucial for their safe and effective administration. In the FAERS database from 2004 to 2024, a total of 18,940 patients with antifungal triazoles were extracted for disproportionality analyses to reflect the degree of association between the TdP/QT prolongation and different antifungal triazoles, and the logistic regression analysis was used to identify potential influencing factors. Additionally, the study examines concomitant medication use in patients who experienced TdP/QT prolongation. Among the overall AEs cases of triazoles, the incidence rate of TdP/QT prolongation was around 2%. A disproportionality analysis indicated that antifungal triazoles were significantly associated with the occurrence of TdP/QT prolongation (reporting odds ratio (ROR) = 7.67 [7.06-8.33], p 30 days vs. ≤ 30 days, OR [95%CI] = 0.23 [0.06-0.89], p = 0.034) had higher risks of death and life-threatening. Finally, we screened out 15 types of concomitant medications that increase the risk of TdP/QT prolongation from triazoles, including Ondansetron, Amiodarone, Levofloxacin, and etc.,which were clearly known to have the side effect of prolonging the QT interval. The TdP/QT prolongation caused by triazoles is a drug safety issue…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 18,940 participants or records.
Read the paper
Related studies
- Ferulic acid regulates the AKT/GSK-3β/CRMP-2 signaling pathway in a middle cerebral artery occlusion animal model
- Novel Pharmacokinetic/Pharmacodynamic Parameters Quantify the Exposure–Effect Relationship of Levofloxacin against Fluoroquinolone-Resistant Escherichia coli
- Photochemical behavior of levofloxacin
- Correlation Between Dissolution Profiles of Salt-Form Drugs in Biorelevant Bicarbonate Buffer and Oral Drug Absorption: Importance of Dose/ Fluid Volume Ratio
- Evaluation of the synergistic potential and mechanisms of action for de novo designed cationic antimicrobial peptides
- Synthesis of [11C]levofloxacin
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.