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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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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Dofetilide and ibutilide, pure class III AADs, are very effective for interrupting AFL intravenously, while class Ia and Ic drugs have little or no effect.
“Dofetilide and ibutilide, pure class III AADs, are very effective for interrupting AFL in intravenous administration, while Class Ia and Ic drugs have little or no effect.138 -142,149”
From European Heart Rhythm Association (EHRA) consensus document on the management of supraventricular arrhythmias, endorsed by Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulacion Cardiaca y Electrofisiologia (SOLAECE) (2017) · cites this paper as [149]
Dofetilide is moderately effective for converting atrial fibrillation or flutter to sinus rhythm and significantly effective for maintaining sinus rhythm, but in-hospital initiation and dose adjustment based on QTc and renal function are needed to minimize a small but not negligible proarrhythmic risk.
“Dofetilide is moderately effective in cardioverting AF or AFL to SR, and significantly effective in maintaining SR but in-hospital initiation and dosage adjustment based on QTc and renal function are necessary to minimize a small but not negligible proarrhythmic risk.149”
From European Heart Rhythm Association (EHRA) consensus document on the management of supraventricular arrhythmias, endorsed by Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulacion Cardiaca y Electrofisiologia (SOLAECE) (2017) · cites this paper as [149]
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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)
- Venue
- Circulation
- Published
- 2000-11-07
- Volume
- 102
- Issue
- 19
- Pages
- 2385-2390
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- 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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