Practice variation in the re-initiation of dofetilide: An observational study

Int J Cardiol. 2017 Jun 1:236:221-225. doi: 10.1016/j.ijcard.2017.01.157. Epub 2017 Feb 12.

Abstract

Background: Dofetilide is a class III antiarrhythmic drug that has been reported to be safe and efficacious in the treatment of atrial dysrhythmias with a known initial risk of QT prolongation and torsades de pointes (TdP). As a result, the Federal Drug Administration (FDA) mandated in-hospital dofetilide initiation and adherence to a common dosing protocol. However, there is a lack of clarity on how to manage dofetilide re-initiation.

Methods: An observational survey was performed including 347 cardiologists in the United States and worldwide to evaluate the deviations from approved manufacturer's protocol during dofetilide initiation and re-initiation among practicing cardiologists.

Results: Most practicing cardiologists were cautious about outpatient dofetilide use and adhered to the manufacturer's in-patient dofetilide protocol during de-novo initiation and reported low incidence of TdP in clinical practice. There were substantial differences among practicing cardiologists with deviation from the manufacturer's protocol during re-initiation of dofetilide. About 21% cardiologists always admitted patients to the hospital while 37% admitted patients <10% of the time for dofetilide re-initiation. Only 4% reported major adverse events with outpatient dofetilide re-initiation. There was also wide variation regarding monitoring of electrolytes and QT interval as an outpatient with dofetilide.

Conclusion: There is significant practice pattern variation in the use of dofetilide for the management of AF. This degree of variation noted is concerning and is a reflection of the current lack of substantial clinical evidence in the re-initiation dofetilide protocol to help direct the provider.

Keywords: Antiarrhythmic drug; Atrial fibrillation; Dofetilide; Practice pattern; Survey; Tikosyn.

Publication types

  • Observational Study

MeSH terms

  • Anti-Arrhythmia Agents / therapeutic use*
  • Atrial Fibrillation / diagnosis
  • Atrial Fibrillation / drug therapy*
  • Cardiologists / standards*
  • Humans
  • Phenethylamines / therapeutic use*
  • Practice Guidelines as Topic / standards*
  • Sulfonamides / therapeutic use*
  • Surveys and Questionnaires
  • Treatment Outcome

Substances

  • Anti-Arrhythmia Agents
  • Phenethylamines
  • Sulfonamides
  • dofetilide