caa a22 4500 397593309 CHVBK 20180308164945.0 cr unu---uuuuu 161202e199605 xx s 000 0 eng 10.1093/jac/37.suppl_A.161 doi (NATIONALLICENCE)oxford-10.1093/jac/37.suppl_A.161 Overview of electrocardiographic and cardiovascular safety data for sparfloxacin [Elektronische Daten] [P. Jaillon, J. Morganroth, I. Brumpt, G. Talbot] 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. © 1996 The British Society for Antimicrobial Chemotherapy Articles nationallicence Jaillon P. Saint Antoine University Medical Centre Paris, France aut Morganroth J. University of Pennsylvania School of Medicine Philadelphia, PA, USA aut Brumpt I. Rhône DPC Europe Antony, France aut Talbot G. Rhône Poulenc Rorer Collegeville, USA aut Journal of Antimicrobial Chemotherapy Oxford University Press 37(1996-05), 161-167 0305-7453 37<161 1996 37 jac https://doi.org/10.1093/jac/37.suppl_A.161 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1093/jac/37.suppl_A.161 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Jaillon P. Saint Antoine University Medical Centre Paris, France aut NATIONALLICENCE 700 1- Morganroth J. University of Pennsylvania School of Medicine Philadelphia, PA, USA aut NATIONALLICENCE 700 1- Brumpt I. Rhône DPC Europe Antony, France aut NATIONALLICENCE 700 1- Talbot G. Rhône Poulenc Rorer Collegeville, USA aut NATIONALLICENCE 773 0- Journal of Antimicrobial Chemotherapy Oxford University Press 37(1996-05), 161-167 0305-7453 37<161 1996 37 jac Metadata rights reserved CC BY-NC-4.0 http://creativecommons.org/licenses/by-nc/4.0 nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-oxford