Publication Spotlight: Sherin Ismail Atta

Interview with Sherin Ismail Atta, PharmD, MPH-epi, BCPS, BCACP, PhD student, Pharmacoepidemiology, Gillings School of Global Public Health, author of Ondansetron and the Risk of Sudden Cardiac Death among Individuals Receiving Maintenance Hemodialysis.

What question did your study aim to answer?

The study aimed to evaluate the comparative cardiac safety of commonly prescribed antiemetics among people receiving maintenance hemodialysis. Specifically, we compared ondansetron, an antiemetic known to prolong the QT-interval, to antiemetics with lesser QT-interval-prolonging potential.

What inspired you to conduct this study?

The risk of sudden cardiac death among individuals receiving hemodialysis is nearly 20-times that of the risk of individuals not receiving dialysis. Several factors such as high prevalence of structural heart disease, electrolyte abnormalities and polypharmacy including the use of medications known to prolong the QT-interval render people receiving hemodialysis at a high risk of cardiac complications, including sudden cardiac death. Ondansetron is known to prolong the QT-interval, but its cardiac safety compared to antiemetics with lesser QT-interval-prolonging potential is unknown.

Which USRDS datasets did you use to conduct your study?

We used the standard analytical USRDS files including core forms (i.e. death notification form- CMS 2746 and medical evidence reports form- CMS 2728), hospital and institutional claims (Medicare Part A), physician/supplier claims (Medicare Part B), and prescription drug claims (Medicare Part D).

Using plain language, please summarize your study conclusions in two or three points.

In a cohort of 119,254 individuals receiving in-center hemodialysis, initiation of oral ondansetron compared to initiation of antiemetics with lesser QT prolonging potential was associated with a higher 10-day risk of sudden cardiac death. Analyses considering additional cardiac outcomes had consistent findings. When selecting antiemetics for people receiving hemodialysis, clinicians should be cognizant of the QT-prolonging potential of the antiemetic.

Please share a specific insight about working with USRDS data that you learned during the completion of this study.

USRDS is a rich data source for researchers as it allows us to leverage real life experiences of people receiving hemodialysis. Proper use of the data has the potential to provide robust evidence that informs patients, clinicians, and policy decision-makers. This is especially important in dialysis as we often lack randomized controlled trials, the gold standard for evidence, for many important clinical decisions.