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Related Experiment Videos

Evaluation of the dofetilide risk-management program.

Nancy M Allen LaPointe1, Anita Chen, Bradley Hammill

  • 1Duke Center for Education and Research on Therapeutics and the Division of Cardiology, Duke Clinical Research Institute, Durham, NC 27715, USA. allen003@mc.duke.edu

American Heart Journal
|November 5, 2003
PubMed
Summary

Dofetilide's risk-management program improved adherence to dosing and monitoring guidelines compared to sotalol. However, the program may have also led to lower dofetilide usage.

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Area of Science:

  • Pharmacology
  • Clinical Pharmacy
  • Drug Safety

Background:

  • Dofetilide and sotalol HCl carry risks of dose-dependent torsades de pointes.
  • Both drugs have dosing and monitoring recommendations in their labeling.
  • Dofetilide has a mandated risk-management program, unlike sotalol.

Purpose of the Study:

  • To compare adherence to dofetilide dosing and monitoring recommendations with and without a risk-management program.
  • To evaluate the impact of dofetilide's risk-management program on adherence compared to sotalol.

Main Methods:

  • Retrospective chart review of 47 patients on dofetilide and 117 patients on sotalol.
  • Comparison of adherence rates to recommended starting doses and baseline tests (potassium, magnesium, serum creatinine, ECG).

Related Experiment Videos

  • Assessment of adherence to post-dose electrocardiogram monitoring.

    • Main Results:

    • Higher adherence to recommended starting doses for dofetilide (79%) vs. sotalol (35%).
    • Improved adherence to baseline tests (potassium, magnesium, creatinine, ECG) in the dofetilide group.
    • Significantly greater adherence to post-dose ECGs for dofetilide (94% after first dose, 80% subsequent) vs. sotalol (43% after first dose, 3.5% subsequent).

    Conclusions:

    • The risk-management program likely enhanced adherence to dofetilide dosing and monitoring.
    • Potential unintended consequence: reduced dofetilide usage during the study period.
    • Further investigation needed on the overall impact of the risk-management program.