References
Malik M. Does the prulifloxacin ECG study prove cardiac safety of the drug? Clin Drug Investig 2010; 30(1): 1–3
Rosignoli MT, Di Loreto G, Dionisio P. Effects of prulifloxacin on cardiac repolarization in healthy subjects: a randomized, crossover, double-blind versus placebo, moxifloxacin-controlled study. Clin Drug Investig 2010; 30(1): 5–14
Committee for Medicinal Products for Human Use (ICH Topic E14). Note for guidance on the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. CHMP/ICH/2/04 London, 25 May 2005 [online]. Available from URL: http://www.ema.europa.eu/pdfs/human/ich/000204en.pdf [Accessed 2010 Jan 15]
Dixon R, Job S, Oliver R, et al. Lamotrigine does not prolong QTc in a thorough QT/QTc study in healthy subjects. Br J Clin Pharmacol 2008; 66: 396–404
Lacroix P, Crumb WJ, Durando L, et al. Prulifloxacin: in vitro (HERG current) and in vivo (conscious dog) assessment of cardiac risk. Eur J Pharmacol 2003; 477(1): 69–72
Akita M, Shibazaki Y, Izumi M, et al. Comparative assessment of prulifloxacin, sparfloxacin, gatifloxacin and levofloxacin in the rabbit model of proarrhythmia. J Toxicol Sci 2004; 29(1): 63–71
Tsikouris JP, Peeters MJ, Cox CD, et al. Effects of three fluoroquinolones on QT analysis after standard treatment courses. Ann Noninvasive Electrocardiol 2006; 11(1): 52–6
Committee for Medicinal Products for Human Use (ICH Topic E14). Note for guidance on the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Questions and answers. EMEA/CHMP/ICH/310133/2008, June 2008 [online]. Available from URL: http://www.ema.europa.eu/pdfs/human/ich/31013308en.pdf [Accessed 2010 Jan 15]
Salvi V, Karnad DR, Panicker GK, et al. Update on the evaluation of a new drug for effects on cardiac repolarization in humans: issues in early drug development. Br J Pharmacol 2010; 159: 34–48
Shah RR, Morganroth J. Evaluating the QT-liability of a drug during its development. Pharm Med 2008; 22: 151–64
Hollister AS, Montague TH. Statistical analysis plans for ECG data: controlling the intrinsic and extrinsic variability in QT data. In: Morganroth J, Gussak I, editors. Cardiac safety of noncardiac drugs. Totowa (NJ): Humana Press, 2005: 239–57
Morganroth J, Ilson BE, Shaddinger BC, et al. Evaluation of vardenafil and sildenafil on cardiac repolarization. Am J Cardiol 2004; 93: 1378–83
Deasi M, Li L, Desta Z, et al. Variability of heart rate correction methods for the QT interval. Br J Clin Pharmacol 2002; 55: 511–7
Malik M, Farbom P, Batchvarov V, et al. Relation between QT and RR intervals is highly individual among healthy subjects: implications for heart rate correction of the QT interval. Heart 2002; 87: 220–8
Committee for Proprietary Medicinal Products (ICH Topic E3). Structure and content of clinical study reports. Step 5. Note for guidance on structure and content of clinical study reports. CPMP/ICH/137/95, July 1996 [online]. Available from URL: http://www.ema.europa.eu/pdfs/human/ich/013795en.pdf [Accessed 2010 Jan 15]
Shah RR. Drugs, QTc interval prolongation and final ICH E14 guideline: an important milestone with challenges ahead. Drug Saf 2005; 28(11): 1009–28
Acknowledgements
The authors are employees of Angelini Pharmaceuticals, ACRAF SpA, Rome, Italy.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Rosignoli, M.T., Dionisio, P. Prulifloxacin ECG Study. Clin. Drug Investig. 30, 275–277 (2010). https://doi.org/10.2165/11311700-000000000-00000
Published:
Issue Date:
DOI: https://doi.org/10.2165/11311700-000000000-00000