Cited by 433Atrial Fibrillation Management and OutcomesCardiac Arrhythmias and TreatmentsCardiac electrophysiology and arrhythmias

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Efficacy and Safety of Oral Dofetilide in Converting to and Maintaining Sinus Rhythm in Patients With Chronic Atrial Fibrillation or Atrial Flutter: The Symptomatic Atrial Fibrillation Investigative Research on Dofetilide (SAFIRE-D) Study

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Singh, Steven, Zoble, Robert G., Yellen, Laurence, Brodsky, Michael A., Feld, Gregory K., Berk, Martin, Billing, Clare B.·2000·Circulation

DOI 10.1161/01.cir.102.19.2385

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Abstract

BACKGROUND: This double-blind, multicenter, placebo-controlled study determined the efficacy and safety of dofetilide in converting atrial fibrillation (AF) or atrial flutter (AFl) to sinus rhythm (SR) and maintaining SR for 1 year. METHODS AND RESULTS: Patients with AF or AFl (n=325) were randomized to 125, 250, or 500 microgram dofetilide or placebo twice daily. Dosages were adjusted for QTc response and, after 105 patients were enrolled, for calculated creatinine clearance (Cl(Cr)). Pharmacological cardioversion rates for 125, 250, and 500 microgram dofetilide were 6.1%, 9.8%, and 29.9%, respectively, versus 1.2% for placebo (250 and 500 microgram versus placebo; P=0.015 and P<0.001, respectively). Seventy percent of pharmacological cardioversions with dofetilide were achieved in 24 hours and 91% in 36 hours. For the 250 patients who successfully cardioverted pharmacologically or electrically, the probability of remaining in SR at 1 year was 0.40, 0.37, 0.58 for 125, 250, and 500 microgram dofetilide, respectively, and 0.25 for placebo (500 microgram versus placebo, P=0.001). Two cases of torsade de pointes occurred, 1 on day 2 and the other on day 3 (0.8% of all patients given active drug); 1 sudden cardiac death, classified as proarrhythmic, occurred on day 8 (0.4% of all patients given active drug). CONCLUSIONS: Dofetilide, a new class III antiarrhythmic agent, is moderately effective in cardioverting AF or AFl to SR and significantly effective in maintaining SR for 1 year. In-hospital initiation and dosage adjustment based on QTc and Cl(Cr) are necessary to minimize a small but nonnegligible proarrhythmic risk.

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Authors: Singh, S., Zoble, R. G., Yellen, L., Brodsky, M. A., Feld, G. K., Berk, M., & Billing, C. B.
Affiliations: United States Department of Veterans Affairs (US)
Pfizer (United States) (US)
ORCID: Singh, Steven
Feld, Gregory K.
Venue: Circulation
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2000-11-07
Volume: 102
Issue: 19
Pages: 2385-2390
ISSN: 0009-7322 (ISSN-L)
1524-4539
DOI: 10.1161/01.cir.102.19.2385
OpenAlex: W2047496300
Cited by: 433
References: 14
Citations by year: 2026: 4 · 2025: 5 · 2024: 12 · 2023: 5 · 2022: 9 · 2021: 11 · 2020: 14 · 2019: 10 · 2018: 15 · 2017: 21 · 2016: 26 · 2015: 23 · 2014: 21 · 2013: 15 · 2012: 13
FWCI: 21.50
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Circulation (publishedVersion)
PubMed (publishedVersion)
Funders: Pfizer
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Arrhythmias and Treatments
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac electrophysiology and arrhythmias
Keywords: dofetilide, atrial fibrillation, atrial flutter, sinus rhythm maintenance, pharmacological cardioversion, class III antiarrhythmic agents, proarrhythmic risk, torsades de pointes, sudden cardiac death, QTc monitoring, creatinine clearance, dose adjustment
MeSH terms: Administration, Oral, Adult, Aged, Anti-Arrhythmia Agents, Atrial Fibrillation, Atrial Flutter, Double-Blind Method, Drug Administration Schedule, Female, Heart Rate, Humans, Male, Middle Aged, Phenethylamines, Placebos, Sulfonamides, Treatment Outcome

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Efficacy and Safety of Oral Dofetilide in Converting to and Maintaining Sinus Rhythm in Patients With Chronic Atrial Fibrillation or Atrial Flutter: The Symptomatic Atrial Fibrillation Investigative Research on Dofetilide (SAFIRE-D) Study

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