Update on the cardiac safety of moxifloxacin

Current Drug Safety

Volumn 7, Issue 2, 2012, Pages 149-163

  Haverkamp, Wilhelm ^a   Kruesmann, Frank ^b   Fritsch, Anna ^b   van Veenhuyzen, David ^c   Arvis, Pierre ^d  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b BAYER PHARMA AG   (Germany)

^c BAYER CORPORATION   (United States)

^d Bayer HealthCare   (France)

Author keywords

Cardiac safety; Comparator antimicrobials; Moxifloxacin; Oral therapy; Phase II IV clinical trials; QTc prolongation; Sequential intravenous oral therapy

Indexed keywords

ALATROFLOXACIN; AMOXICILLIN; AMPICILLIN; AZITHROMYCIN; CEFALEXIN; CEFIXIME; CEFTRIAXONE; CEFUROXIME AXETIL; CIPROFLOXACIN; CLARITHROMYCIN; CLAVULANIC ACID; DOXYCYCLINE; ERYTHROMYCIN; LEVOFLOXACIN; METRONIDAZOLE; MOXIFLOXACIN; OFLOXACIN; PIPERACILLIN; ROXITHROMYCIN; SULBACTAM; SULFAMETHOXAZOLE; SULTAMICILLIN; TAZOBACTAM; TRIMETHOPRIM; TROVAFLOXACIN;

ABDOMINAL INFECTION; ADULT; ANTIBIOTIC THERAPY; ARTICLE; ASPIRATION PNEUMONIA; BACTERIAL SINUSITIS; CARDIOPULMONARY INSUFFICIENCY; CARDIOVASCULAR DISEASE; CHRONIC BRONCHITIS; COMMUNITY ACQUIRED PNEUMONIA; CONSCIOUSNESS DISORDER; DRUG SAFETY; FAINTNESS; FEMALE; HEART ARREST; HEART VENTRICLE ARRHYTHMIA; HEART VENTRICLE FIBRILLATION; HEART VENTRICLE TACHYCARDIA; HOSPITAL ACQUIRED PNEUMONIA; HUMAN; INCIDENCE; LUNG ABSCESS; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; PELVIC INFLAMMATORY DISEASE; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIDE EFFECT; SINGLE DRUG DOSE; SKIN INFECTION; STREPTOCOCCAL PHARYNGITIS; SUDDEN DEATH; TORSADE DES POINTES; TREATMENT INDICATION; URINARY TRACT INFECTION;

EID: 84870349833     PISSN: 15748863     EISSN: None     Source Type: Journal    
DOI: 10.2174/157488612802715735     Document Type: Article

References (59)

1. Mackin P. Cardiac side effects of psychiatric drugs. Hum Psychopharmacol Clin Exp 2008; 23(Suppl 1): 3-14.
2. Perlis RH. Treatment of bipolar disorder: the evolving role of atypical antipsychotics. Am J Manag Care 2007; 13(7 Suppl): S178-88.
3. Haverkamp W, Breithardt G, Camm AJ, et al. The potential for QT prolongation and pro-arrhythmia by non-anti-arrhythmic drugs: clinical and regulatory implications. Report on a Policy Conference of the European Society of Cardiology. Cardiovasc Res 2000; 47: 219-33.
4. Salvi V, Karnad DR, Panicker GK, Kothari S. 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.
5. Estelle F, Simons R. H1-receptor antagonists: safety issues. Ann Allergy Asthma Immunol 1999; 83: 481-8.
6. Roden DM. Drug-induced prolongation of the QT interval. N Engl J Med 2004; 350: 1013-22.
7. Iannini PB. Cardiotoxicity of macrolides, ketolides and fluoroquinolones that prolong the QTc interval. Expert Opin Drug Saf 2002; 1: 121-8.
8. ®400 mg tablets. Summary of Product Characteristics. Sanofi-Aventis, UK, updated 03/06/2008.
9. Jaillon P, Morganroth J, Brumpt I, Talbot G. Overview of electrocardiographic and cardiovascular safety data for sparfloxacin. Sparfloxacin Safety Group. J Antimicrob Chemother 1996; 37(Suppl A): 161-7.
10. Ball P. Quinolone-induced QT interval prolongation: a not-sounexpected class effect. J Antimicrob Chemother 2000; 45: 557-9.
11. van Bambeke F, Tulkens PM. Safety profile of the respiratory fluoroquinolone moxifloxacin: comparison with other fluoroquinolones and other antibacterial classes. Drug Saf 2009; 32: 359-78.
12. Démolis JL, Kubitza D, Tennezé L, Funck-Brentano C. Effect of a single oral dose of moxifloxacin (400 mg and 800 mg) on ventricular repolarization in healthy subjects. Clin Pharmacol Ther 2000; 68: 658-66.
13. Taubel J, Naseem A, Harada T, et al. Levofloxacin can be used effectively as a positive control in thorough QT/QTc studies in healthy volunteers. Br J Clin Pharmacol 2010; 69: 391-400.
14. Owens RC Jr. Risk assessment for antimicrobial agent-induced QTc interval prolongation and torsades de pointes. Pharmacotherapy 2001; 21: 301-19.
15. Poluzzi E, Raschi E, Motola D, Moretti U, De Ponti F. Antimicrobials and the risk of torsades de pointes: the contribution from data mining of the US FDA Adverse Event Reporting System. Drug Saf 2010; 33: 303-14.
16. Chen X, Cass JD, Bradley JA, et al. QT prolongation and proarrhythmia by moxifloxacin: concordance of preclinical models in relation to clinical outcome. Br J Pharmacol 2005; 146: 792-9.
17. Alexandrou AJ, Duncan RS, Sullivan A, et al. Mechanism of hERG K+ channel blockade by the fluoroquinolone antibiotic moxifloxacin. Br J Pharmacol 2006; 147: 905-16.
18. Malik M, Garnett CE, Zhang J. Thorough QT studies: questions and quandaries. Drug Saf 2010; 33: 1-14.
19. Malik M, Hnatkova K, Schmidt A, Smetana P. Electrocardiographic QTc changes due to moxifloxacin infusion. J Clin Pharmacol 2009; 49: 674-83.
20. Finch R, Schürmann D, Collins O, et al. Randomized controlled trial of sequential intravenous (i.v.) and oral moxifloxacin compared with sequential i.v. and oral co-amoxiclav with or without clarithromycin in patients with community-acquired pneumonia requiring initial parenteral treatment. Antimicrob Agents Chemother 2002; 46: 1746-54.
21. Welte T, Petermann W, Schürmann D, Bauer TT, Reimnitz P and the MOXIRAPID Study Group. Treatment with sequential intravenous or oral moxifloxacin was associated with faster clinical improvement than was standard therapy for hospitalized patients with community-acquired pneumonia who received initial parenteral therapy. Clin Infect Dis 2005; 41: 1697-705.
22. Torres A, Garau J, Arvis P, et al.; MOTIV (MOxifloxacin Treatment IV) Study Group. Moxifloxacin monotherapy is effective in hospitalized patients with community-acquired pneumonia: the MOTIV study-a randomized clinical trial. Clin Infect Dis 2008; 46: 1499-509.
23. Weiss G, Reimnitz P, Hampel B, Muehlhofer E, Lippert H; AIDA Study Group. Moxifloxacin for the treatment of patients with complicated intra-abdominal infections (the AIDA Study). J Chemother 2009; 21: 170-80.
24. Faich GA, Morganroth J, Whitehouse AB, et al. Clinical experience with moxifloxacin in patients with respiratory tract infections. Ann Pharmacother 2004; 38: 749-54.
25. Morganroth J, Dimarco JP, Anzueto A, Niederman MS, Choudhri S; CAPRIE Study Group. A randomized trial comparing the cardiac rhythm safety of moxifloxacin vs levofloxacin in elderly patients hospitalized with community-acquired pneumonia. Chest 2005; 128: 3398-406.
26. Drici MD, Knollmann BC, Wang WX, Woosley RL. Cardiac actions of erythromycin: influence of female sex. JAMA 1998; 280: 1774-6.
27. Makkar RR, Fromm BS, Steinman RT, Meissner MD, Lehmann MH. Female gender as a risk factor for torsades de pointes associated with cardiovascular drugs. JAMA 1993; 270: 2590-7.
28. Rautaharju PM, Zhou SH, Wong S, et al. Sex differences in the evolution of the electrocardiographic QT interval with age. Can J Cardiol 1992; 8: 690-5.
29. Mangoni AA, Kinirons MT, Swift CG, Jackson SH. Impact of age on QT interval and QT dispersion in healthy subjects: a regression analysis. Age Ageing 2003; 32: 326-31.
30. EMA/CHMP/PhVWP. Monthly Report. Accessed: http://www.em a.europa.eu/docs/en_GB/document_library/Report/2011/01/WC500 100459.pdf
31. Romero K, Woosley R. Clarification to the www.qtdrugs.org updated lists. Pharmacoepidemiol Drug Saf 2009; 18: 423-24.
32. QT Drug List by Risk Groups [Internet]. Tucson, AZ: Arizona CERT (Center for Education and Research on Therapeutics) [cited 2011 Oct 4]. Available from: http://www.qtdrugs.org/
33. ®400 mg tablets [Internet]. Newbury, UK: Bayer Pharma [2010, cited 2010 Sept 15]. Available from: http://www.medicines.org.uk/EMC/medicine/ 11841/SPC/Avelox+400+mg+film-coated+tablets
34. ®400 mg/250 ml solution for infusion [Internet]. Newbury, UK: Bayer Pharma [2010, cited 2010 Sept 15]. Available from: http://www.medici nes.org.uk/EMC/medicine/22827/SPC/Avelox+400+mg+250+ml+s olution+for+infusion/
35. Ball P, Stahlmann R, Kubin R, Choudhri S, Owens R. Safety profile of oral and intravenous moxifloxacin: cumulative data from clinical trials and postmarketing studies. Clin Ther 2004; 26: 940-50.
36. Kubitza D, Mueck W, Becka M. Randomized, double-blind, crossover study to investigate the effect of rivaroxaban on QTinterval prolongation. Drug Saf 2008; 31: 67-77.
37. Hulhoven R, Rosillon D, Letiexhe M, et al. Levocetirizine does not prolong the QT/QTc interval in healthy subjects: results from a thorough QT study. Eur J Clin Pharmacol 2007; 63: 1011-17.
38. Stylianou A, Roger J, Stephens K. A statistical assessment of QT data following placebo and moxifloxacin dosing in thorough QT studies. J Biopharm Stat 2008; 18: 502-16.
39. Bloomfield DM, Kost JT, Ghosh K, et al. The effect of moxifloxacin on QTc and implications for the design of thorough QT studies. Clin Pharmacol Ther 2008; 84: 475-80.
40. Luo S, Michler K, Johnston P, Macfarlane PW. A comparison of commonly used QT correction formulae: the effect of heart rate on the QTc of normal ECGs. J Electrocard 2004; 37(Suppl): 81-90.
41. +channel HERG. Mol Pharmacol 2001; 59: 122-6.
42. U.S. Food and Drug Administration. International Conference on Harmonization (ICH). E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs [Internet]. Current Step 4 version dated 12 May 2005. Available from: http://www.fda.gov/RegulatoryInformation/Guidan ces/ucm129335.htm
43. Vos MA. Literature-based evaluation of four 'hard endpoint' models for assessing drug-induced torsades de pointes liability. Br J Pharmacol 2008; 154: 1523-7.
44. Wisialowski T, Crimin K, Engtrakul J, et al. Differentiation of arrhythmia risk of the antibacterials moxifloxacin, erythromycin, and telithromycin based on analysis of monophasic action potential duration alternans and cardiac instability. J Pharmacol Exp Ther 2006; 318: 352-9.
45. Mignot A. Clinical practices ensuring optimal quality of a thorough QT study. Life Sci Tech Bull March 2009; 22: 1-4.
46. Briasoulis A, Agarwal V, Pierce WJ. QT prolongation and torsade de pointes induced by fluoroquinolones: infrequent side effects from commonly used medications. Cardiology 2011; 120: 103-10.
47. Morganroth J, Brozovich FV, McDonald JT, Jacobs RA. Variability of the QT measurement in healthy men, with implications for selection of an abnormal QT value to predict drug toxicity and proarrhythmia. Am J Cardiol 1991; 67: 774-6.
48. Moss AJ. Measurement of the QT interval and the risk associated with QTc interval prolongation: a review. Am J Cardiol 1993; 72: 23B-25B.
49. Morganroth J, Brown AM, Critz S, et al. Variability of the QTc interval: impact on defining drug effect and low-frequency cardiac event. Am J Cardiol 1993; 72: 26B-31B.
50. Roden DM. Role of the electrocardiogram in determining electrophysiologic end points of drug therapy. Am J Cardiol 1988; 62: 34H-38H.
51. Johnson JN, Ackerman MJ. QTc: how long is too long? Br J Sports Med 2009; 43: 657-62.
52. Owens RC Jr, Ambrose PG. Torsades de pointes associated with fluoroquinolones. Pharmacotherapy 2002; 22: 663-8.
53. Le Berre MA, Stass H, Choudri SH, Arvis P. Relationship of plasma concentration and changes in the QTc interval in hospitalized patients receiving intravenous moxifloxacin for the treatment of community-acquired pneumonia (CAP). European Congress of Clinical Microbiology and Infectious Diseases 2007, P2069.
54. Mason JW, Florian JA Jr, Garnett CE, Moon TE, Selness DS, Spaulding RR. Pharmacokinetics and pharmacodynamics of three moxifloxacin dosage forms: implications for blinding in activecontrolled cardiac repolarization studies. J Clin Pharmacol 2010; 50: 1249-59.
55. Yan LK, Zhang J, Ng MJ, Dang Q. Statistical characteristics of moxifloxacin-induced QTc effect. J Biopharm Stat 2010; 20:497-507.
56. Tsikouris JP, Peeters MJ, Cox CD, Meyerrose GE, Seifert CF. Effects of three fluoroquinolones on QT analysis after standard treatment courses. Ann Noninvasive Electrocardiol 2006; 11: 52-6.
57. Dale KM, Lertsburapa K, Kluger J, White CM. Moxifloxacin and torsade de pointes. Ann Pharmacother 2007; 41: 336-40.
58. Badshah A, Janjua M, Younas F, Halabi AR, Cotant JF. Moxifloxacin-induced QT prolongation and torsades: an uncommon effect of a common drug. Am J Med Sci 2009; 338: 164-6.
59. Anonymous. Statistical Principles for Clinical Trials. Available from URL: http://www.ich.org/MediaServer.jser?@_ID=485&@_ MODE=GLB) (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) [accessed 16 Jan. 2011].