Evaluation of Loperamide’s Effect on Heart Rhythm
Study Overview
This study explored how loperamide, a medication, affects the heart’s repolarization interval. It looked at both loperamide and its metabolite (M1) to see if they prolong the QT interval at normal and high doses.
Study Design
The analysis used data from healthy adults in a controlled trial. Participants received different treatments: a placebo, 8 mg of loperamide (normal dose), 48 mg of loperamide (high dose), and 400 mg of moxifloxacin (a positive control). Heart activity was measured using 12-lead electrocardiograms that were timed with blood samples for loperamide and M1.
Key Findings
- A total of 53 participants provided 1,408 measurements for analysis.
- At the high dose, there was a delay in response between loperamide/M1 levels and the QT interval changes.
- The study found that loperamide and M1 do not significantly affect heart rhythm in healthy individuals at doses up to 48 mg.
- The maximum predicted change in QT interval was less than 10 msec, which is below the safety concern threshold.
Clinical Implications
These results suggest that loperamide is safe for heart rhythm at the tested doses.
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