Skip to main content
SpringerLink
Log in

Does the Prulifloxacin ECG Study Prove Cardiac Safety of the Drug?

  • Commentary
  • Published:
Clinical Drug Investigation Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  1. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Guidance to industry. Fed Regist 2005; 70: 61134–5

    Google Scholar 

  2. 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: 5–14

    Article  CAS  Google Scholar 

  3. Darpo B, Nebout T, Sager PT. 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

    Article  CAS  Google Scholar 

  4. Shah RR. Cardiac repolarisation and drug regulation: assessing cardiac safety 10 years after the CPMP guidance. Drug Saf 2007; 30: 1093–110

    Article  Google Scholar 

  5. Malik M, Garnett C, Zhang J. Thorough QT studies: questions and quandaries. Drug Saf 2010; 1-14

    Article  Google Scholar 

  6. Garnett CE, Beasley N, Bhattaram VA, et al. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review. J Clin Pharmacol 2008; 48: 13–8

    Article  CAS  Google Scholar 

  7. Malik M, Hnatkova K, Schmidt A, et al. Electrocardiographic QTc changes due to moxifloxacin infusion. J Clin Pharmacol 2009; 49: 674–83

    Article  CAS  Google Scholar 

  8. Tsikouris JP, Peeters MJ, Cox CD, et al. Effects of three fluoroquinolones on QT analysis after standard treatment courses. Ann Noninvasive Electrocardiol 2006; 11: 52–6

    Article  Google Scholar 

  9. Malik M. Errors and misconceptions in ECG measurement used for the detection of drug induced QT interval prolongation. J Electrocardiol 2004; 37 Suppl.: 25–33

    Article  Google Scholar 

  10. Franz MR, Swerdlow CD, Liem LB, et al. Cycle length dependence of human action potential duration in vivo: effects of single extrastimuli, sudden sustained rate acceleration and deceleration, and different steady-state frequencies. J Clin Invest 1988; 82: 972–9

    Article  CAS  Google Scholar 

  11. Fenichel RR, Malik M, Antzelevitch C, et al. Drug-induced torsades de pointes and implications for drug development. J Cardiovasc Electrophysiol 2004; 15: 475–95

    Article  Google Scholar 

  12. Malik M, Hnatkova K, Ford J, et al. Near-thorough QT study as part of a first-in-man study. J Clin Pharmacol 2008; 48: 1146–57

    Article  CAS  Google Scholar 

  13. Malik M, Andreas J-O, Hnatkova K, et al. Thorough QT/QTc study in patients with advanced Parkinson’s disease: cardiac safety of rotigotine. Clin Pharmacol Ther 2008; 84: 595–603

    Article  CAS  Google Scholar 

Download references

Acknowledgements

This commentary was not supported by any external funding. The author has no conflicts of interest that are directly relevant to the content of this commentary.

Author information

Authors and Affiliations

  1. St Paul’s Cardiac Electrophysiology and St George’s, University of London, London, England

    Marek Malik

Authors
  1. Marek Malik
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Marek Malik.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Malik, M. Does the Prulifloxacin ECG Study Prove Cardiac Safety of the Drug?. Clin. Drug Investig. 30, 1–3 (2010). https://doi.org/10.2165/11319780-000000000-00000

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/11319780-000000000-00000

Keywords

Search

Navigation