Cardiovascular Monitoring in Normal Healthy Adults: A Literature Review and Recommendations for the Reporting of Disturbances of Cardiac Rhythm.
Continuous monitoring of the electrocardiogram has become a commonly used technique in the safety assessment of new drugs when these are administered to human beings for the first time. Disturbances of cardiac rhythm have been observed with cardiac monitoring during clinical pharmacology studies in normal healthy volunteers. It is often difficult to assess the clinical significance of these rhythms especially when these rhythms occur following the administration of new drugs to human beings for the first time. Certain arrhythmias are frequently noted in normal healthy adults, including sinus bradycardia, sinus arrhythmia, the Wenckebach type of second-degree AV block (Mobitz I), atrioventricular junctional rhythm, PAC's, and PVC's. PAC's and PVC's are commonly observed, although greater than 50 PVC's/24 hr and greater than 100 PAC's/hr are relatively rare. Atrial couplets/atrial tachycardia and ventricular couplets/nonsustained ventricular tachycardia are relatively rare, but nevertheless do occur on occassion in normal healthy adults. With these consideration in mind, a guideline for the interpretation and reporting of cardiac arrhythmias occurring during clinical pharmacology studies in normal healthy adults is presented. The absence of symptoms or structural heart disease are important considerations in the evaluation of arrhythmias in normal healthy adults. The severity and seriousness of the adverse experience should be left up to the investigator's discretion. Rechallenge with active drug or placebo should be considered on a case-by-case basis.
Ilson
Bernard E.
BE