The Effect of Carbetocin on Cardiac Repolarization: A Randomized, Placebo- and Positive-Controlled QT/QTc Study in Healthy Adults.
Daniël M Jonker, Katie Barletta, Ekaterine Bagci et al.
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In 30 seconds
This randomized controlled trial assessed the impact of a supratherapeutic dose of carbetocin on cardiac repolarization in 42 healthy adults. The study found that a single intravenous infusion of carbetocin resulted in a mean placebo-corrected change in the optimized heart rate-corrected QT interval (oQTcI) of 4.5 msec (90% CI: 3.4, 5.6) at a high clinical exposure level, indicating no significant QTc prolongation of clinical concern.
Key findings
- The maximum heart rate change during carbetocin infusion was 16.7 bpm.
- The estimated mean placebo-corrected oQTcI change was 4.5 msec at a carbetocin exposure of 12.4 ng/mL.
- No predicted QTc prolongations of ≥ 10 msec were observed at high clinical exposure levels.
Why it matters
Understanding the cardiac effects of medications like carbetocin is crucial for ensuring patient safety, particularly in populations at risk for cardiac arrhythmias. This study provides important data on the drug's cardiac repolarization profile.