Effect of single 500 mg iv. levofloxacin dose on QT interval in healthy subjects

Japanese Journal of Chemotherapy

Volumn 57, Issue 2, 2009, Pages 106-114

  Sugiyama, Atsushi ^a   Fukuda, Ryoko ^b   Mori, Koji ^b   Fujita, Tomoe ^c   Kumagai, Yuji ^c  

^a UNIVERSITY OF YAMANASHI   (Japan)

^b DAIICHI SANKYO INC   (United States)

^c KITASATO UNIVERSITY HOSPITAL   (Japan)

Author keywords

Levofloxacin; QT interval

Indexed keywords

LEVOFLOXACIN; PLACEBO; SODIUM CHLORIDE;

ADOLESCENT; ADULT; AGE DISTRIBUTION; AGED; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION COEFFICIENT; CROSSOVER PROCEDURE; DOSE RESPONSE; DRUG EFFICACY; ELECTROCARDIOGRAPHY; FEMALE; HEART RATE; HUMAN; HUMAN EXPERIMENT; JAPANESE; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; QT INTERVAL; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; SEX DIFFERENCE; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; TORSADE DES POINTES;

EID: 63649098952     PISSN: 13407007     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (38)

1. Sugiyama A: Sensitive and reliable proarrhythmia in vivo animal models for predicting drug-induced torsades de pointes in patients with remodelled hearts. Br J Pharmacol 2008; 154: 1528-37
2. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: The Non-Clinical Evaluation of The Potential For Delayed Ventricular Repolarization (Qt Interval Prolongation) by Human Pharmaceuticals: S7B. Geneva, Switzerland; 2005. Available at http:///www.ich.org/LOB/media/ MEDIA2192.pdf
3. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs: E14. Geneva, Switzerland; 2005. Available at http://www.ich.org/LOB/media/MEDIA1476.pdf
4. Ball P: Quinolone-induced QT interval prolongation: a not-so-unexpected class effect. J Antimicrob Chemother 2000; 45: 557-9
5. Rubinstein E, Camm J: Cardiotoxicity of fluoroquinolones. J Antimicrob Chemother 2002; 49: 593-6
6. Japanese source.
7. Dupont H, Timsit J F, Souweine B, Gachot B, Wolff M, Regnier B: Torsades de pointe probably related to sparfloxacin. Eur J Clin Microbiol Infect Dis 1996; 15: 350-1
8. Japanese source.
9. Furuhama K: Toxicology assessment of fluoroquinolones: a case study. In Sietsema W K, Schwen R (ed.), Nonclinical drug safety assessment: practical considerations for successful Registration, FDA News. Falls Church, USA. 2007; p. 571-88
10. Samaha F F: QTc interval prolongation and polymorphic ventricular tachycardia in association with levofloxacin. Am J Med 1999; 107: 528-9
11. Paltoo B, O'Donoghue S, Moussavi M S: Levofloxacin induced polymorphic ventricular tachycardia with normal QT interval. PACE 2001; 24: 895-7
12. Iannini P B, Doddamani S, Byazrova E, Curciumaru I, Kramer H: Risk of torsades de pointes with non-cardiac drugs. Prolongation of QT interval is probably a class effect of fluoroquinolones. BMJ 2001; 322: 46-7
13. Caliendo G C, Cheng J W, Fajardo M L, Fisher L A, Meyer J: [P-586 (D)] Prolonged QT interval associated with dofetilide, levofloxacin and hypokalemia. Am J Health Syst Pharm 2003; 60
14. Gandhi P J, Menezes P A, Vu H T, Rivera A L, Ramaswamy K: Fluconazole- and levofloxacin-induced torsades de pointes in an intensive care unit patient. Am J Health Syst Pharm 2003; 60: 2479-83, Erratum in: Am J Health Syst Pharm 2004; 61: 141
15. Amankwa K, Krishnan S C, Tisdale J E: Torsades de pointes associated with fluoroquinolones: importance of concomitant risk factors. Clin Pharmacol Ther 2004; 75: 242-7
16. Nykamp D L, Blackmon C L, Schmidt P E, Roberson A G: QTc prolongation associated with combination therapy of levofloxacin, imipramine, and fluoxetine. Ann Pharmacother 2005; 39: 543-6
17. Maxa J L, Hebeler R F, Adeeko M A: Torsades de pointes following concurrent amiodarone and levofloxacin therapy. Proc (Bayl Univ Med Cent) 2006; 19: 345-6
18. Andes D, Craig W A: Animal model pharmacokinetics and pharmacodynamics: a critical review. Int J Antimicrob Agents 2002; 19: 261-8
19. Blondeau J M, Zhao X, Hansen G, Drlica K: Mutant prevension concentrations of fluoroquinolones for clinical isolates of Streptococus pneumoniae. Antimicrob Agents Chemother 2001; 45: 433-8
20. Noel G J, Goodman D B, Chien S, Solanki B, Padmanabhan M, Natarajan J: Measuring the effects of supratherapeutic doses of levofloxacin on healthy volunteers using four methods of QT correction and periodic and continuous ECG recordings. J Clin Pharmacol 2004; 44: 464-73
21. Okazaki O, Aoki H, Hakusui H: High-performance liquid chromatographic determination of (S)-(-)- ofloxacin and its metabolites in serum and urine using a solid-phase clean-up. J Chromatogr 1991; 563: 313-22
22. Fridericia L S: Die Systolendauer im Elektrokardiogramm bei normalen Menschen und bei Herzkranken. Acta Med Scand 1920; 53: 469-86
23. Bazett H C: An analysis of the time-relations of electrocardiograms. Heart 1920; 7: 353-70
24. Patterson S D, Agin M, Anziano R, Burgess T, Chuang-Stein C, Dmitrienko A, et al: Investigating drug-induced QT and QTc prolongation in the clinic: a review of statistical design and analysis considerations: Report from the pharmaceutical research and manufacturers of America QT statistics expert team. Drug Inf J 2005; 39: 243-66
25. Shah R R: The significance of QT interval in drug development. Br J Clin Pharmacol 2002; 54: 188-202
26. Makkar R R, Fromm B S, Steinman R T, Meissner M D, Lehmann M H: Female gender as a risk factor for torsades de pointes associated with cardiovascular drugs. JAMA 1993; 270: 2590-7
27. Bednar M M, Harrigan E P, Ruskin J N: Torsades de pointes associated with nonantiarrhythmic drugs and observations on gender and QTc. Am J Cardiol 2002; 89: 1316-9
28. Crouch M A, Limon L, Cassano A T: Clinical relevance and management of drug-related QT interval prolongation. Pharmacotherapy 2003; 23: 881-908
29. Benoit S R, Mendelsohn A B, Nourjah P, Staffa J A, Graham D J: Risk factors for prolonged QTc among US adults: Third National Health and Nutrition Examination Survey. Eur J Cardiovasc Prev Rehabil 2005; 12: 363-8
30. + channel HERG. Mol Pharmacol 2001; 59: 122-6
31. Hagiwara T, Satoh S, Kasai Y, Takasuna K: A comparative study of the fluoroquinolone antibacterial agents on the action potential duration in guinea pig ventricular myocardia. Jpn J Pharmacol 2001; 87: 231-4
32. Noel G J, Natarajan J, Chien S, Hunt T L, Goodman D B, Abels R: Effects of three fluoroquinolones on QT interval in healthy adults after single doses. Clin Pharmacol Ther 2003; 73: 292-303
33. Darpo B, Nebout T, Sager P T: Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 guideline. J Clin Pharmacol 2006; 46: 498-507
34. Japanese source.
35. Japanese source.
36. Japanese source.
37. Akita M, Shibazaki Y, Izumi M, Hiratsuka K, Sakai T, Kurosawa T, et al: Comparative assessment of prurifloxacin, sparfloxacin, gatifloxacin and levofloxacin in the rabbit model of proarrhythmia. J Toxicol Sci 2004; 29: 63-71
38. Chiba K, Sugiyama A, Satoh Y, Shiina H, Hashimoto K: Proarrhythmic effects of fluoroquinolone antibacterial agents: in vivo effects as physiologic substrate for torsades. Toxicol Appl Pharmacol 2000; 169: 8-16