Abstract: TH-OR99
Ondansetron and the Risk of Sudden Cardiac Death Among Patients Receiving Hemodialysis
Session Information
- Onconephrology and Precision Pharmacology
November 02, 2023 | Location: Room 107, Pennsylvania Convention Center
Abstract Time: 05:42 PM - 05:51 PM
Category: Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)
- 2000 Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)
Authors
- Ismail, Sherin, The University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, North Carolina, United States
- Jonsson Funk, Michele, The University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, North Carolina, United States
- Flythe, Jennifer E., The University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, United States
Background
Sudden cardiac death (SCD) is common among hemodialysis (HD) patients. Ondansetron, an antiemetic with known QT prolonging potential, has a Food and Drug Administration warning about its association with fatal arrythmias in the general population. The cardiac safety of ondansetron in the HD population is unknown.
Methods
We conducted a new-user, active-comparator, cohort study using US Renal Data System data (2012-2019) to assess the comparative 10-day risk of SCD between HD patients initiating ondansetron vs. non-QT-prolonging antiemetics (metoclopramide/prochlorperazine/ promethazine). We used inverse probability of treatment weighting and Fine and Gray proportional subdistribution hazard models to estimate adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs). We used an intention-to-treat approach and treated non-SCD as a competing event. In secondary analyses, we considered broader cardiac outcomes.
Results
Of 119,254 study patients, 64,978 (54.5%) initiated ondansetron and 54,276 (45.5%) initiated a comparator antiemetic. The mean age ± SD was 60 ±15 years, median (IQR) years on HD was 2.2 (0.9, 4.6), and 55% were female. Ondansetron vs. comparator antiemetic initiation was associated with higher relative and absolute 10-day risks of SCD, aHR (95% CI) = 1.45 (1.08, 1.93); weighted risk difference (95% CI) = 0.06% (0.01,0.11). The number needed to harm was 1,672 ondansetron initiations. Analyses of other cardiac outcomes yielded similar findings.
Conclusion
Ondansetron (vs. comparator antiemetic) treatment was associated with higher absolute and relative 10-day risks of SCD among HD patients. Our findings may inform prescriber decisions about antiemetic selection in the HD population.
Figure 1. The 10-day SCD risk among hemodialysis patients initiating ondansetron vs. a non-QT-prolonging antiemetic.
Funding
- Other NIH Support