Overview of electrocardiographic and cardiovascular safety data for sparfloxacin. Sparfloxacin Safety Group

Abstract

During the preclinical development of sparfloxacin, prolongation of the electrocardiographic QT interval was observed in dogs. Subsequently, the effect of sparfloxacin on the QTc interval in man was studied in Phase I studies in healthy volunteers. An independent Safety Board was established to evaluate the electrocardiograms, provide an assessment of the clinical consequences of prolongation of the QT interval, and advise on the design of current and future studies. Results of Phase I and Phase III studies have been consistent and indicate that the increase in QTc interval associated with sparfloxacin is moderate (3% on average) and that patients with renal or hepatic impairment are not at increased risk. Few serious adverse cardiovascular events have been reported during post-marketing surveillance of sparfloxacin and all have occurred in patients with an underlying cardiac condition.