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Erschienen in:
01.12.2000 | Clinical Pharmacodynamics
Studies in Healthy Volunteers do not Show any Electrocardiographic Effects with Esomeprazole
Erschienen in: Clinical Drug Investigation | Ausgabe 6/2000
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Objectives: Esomeprazole is the first proton pump inhibitor developed as an optical isomer. The aim of this study was to assess the potential effects of this agent on the electrocardiogram (ECG) in healthy volunteers.
Study Participants and Methods: A pooled analysis was performed of 82 healthy male and female volunteers who received esomeprazole 40mg once daily in phase I open-label studies. 12-lead ECG recordings were completed at an initial screening visit (baseline) and at 1.5 and 3 hours postdose following esomeprazole administration for 5 to 7 days. The ECG recordings were interpreted by independent cardiologists blinded to the participants’ drug treatment status. Participants were not allowed to have any concomitant medication.
Results: At both 1.5 and 3 hours postdose, mean changes in QT and QTc intervals were small, and there was no clinically meaningful shift in the population means. Mean QTc interval showed a slight decrease overall. For all participants, absolute interlead dispersion was well within the tolerability margin of 100msec. No abnormal T or U waves, arrhythmias or other abnormalities were noted. Esomeprazole was well tolerated and there were no clinically relevant changes in tolerability variables.
Conclusions: In this study of 82 healthy young individuals, esomeprazole, at a dose of 40mg, did not exhibit clinically relevant electrocardiographic effects.