Evaluation of the dofetilide risk-management program.

Journal Article (Academic article)

BACKGROUND: Dose-dependent torsades de pointes has been shown to occur with dofetilide (Tikosyn) and sotalol HCl (Betapace AF); thus, detailed dosing and monitoring recommendations to minimize this risk are included in the product labeling for both drugs. Only dofetilide, however, has a mandated risk-management program that restricts distribution of the drug and requires prescriber education on the drug. We investigated whether this program improved adherence to dosing and monitoring recommendations for dofetilide as compared with sotalol. METHODS: Charts for 47 patients taking dofetilide and 117 patients taking sotalol were reviewed. RESULTS: The recommended starting dose was prescribed more frequently in the dofetilide group than in the sotalol group (79% vs 35%, P

Duke Authors

Cited Authors

  • Allen LaPointe, NM; Chen, A; Hammill, B; DeLong, E; Kramer, JM; Califf, RM

Published Date

  • November 2003

Published In

Volume / Issue

  • 146 / 5

Start / End Page

  • 894 - 901

PubMed ID

  • 14597941

International Standard Serial Number (ISSN)

  • 1097-6744

Conference Location

  • united states