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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ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation31This document was approved by the American College of Cardiology Board of Trustees in August 2001, the American Heart Association Science Advisory and Coordinating Committee in August 2001, and the European Society of Cardiology Board and Committee for Practice Guidelines and Policy Conferences in August 2001.32When citing this document, the American College of Cardiology, the American Heart Association, and the European Society of Cardiology would appreciate the following citation format: Fuster V, Rydén LE, Asinger RW, Cannom DS, Crijns HJ, Frye RL, Halperin JL, Kay GN, Klein WW, Lévy S, McNamara RL, Prystowsky EN, Wann LS, Wyse DG. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation). J Am Coll Cardiol 2001;38:XX-XX.33This document is available on the World Wide Web sites of the American College of Cardiology (www.acc.org), the American Heart Association (www.americanheart.org), the European Society of Cardiology (www.escardio.org), and the North American Society of Pacing and Electrophysiology (www.naspe.org). Single reprints of this document (the complete Guidelines) to be published in the mid-October issue of the European Heart Journal are available by calling +44.207.424.4200 or +44.207.424.4389, faxing +44.207.424.4433, or writing Harcourt Publishers Ltd, European Heart Journal, ESC Guidelines – Reprints, 32 Jamestown Road, London, NW1 7BY, United Kingdom. Single reprints of the shorter version (Executive Summary and Summary of Recommendations) published in the October issue of the Journal of the American College of Cardiology and the October issue of Circulation, are available for $5.00 each by calling 800-253-4636 (US only) or by writing the Resource Center, American College of Cardiology, 9111 Old Georgetown Road, Bethesda, Maryland 20814. To purchase bulk reprints specify version and reprint number (Executive Summary 71-0208; full text 71-0209) up to 999 copies, call 800-611-6083 (US only) or fax 413-665-2671; 1000 or more copies, call 214-706-1466, fax 214-691-6342; or E-mail: pubauth@heart.org.
Fuster, V., Rydén, L., ASINGER, R. W., Cannom, D. S., Crijns, H. J. G. M., Frye, R. L., Halperin, J. L., Kay, G. N., Klein, W. W., Lévy, S., et al. (2001) · Journal of the American College of Cardiology · doi:10.1016/s0735-1097(01)01586-8 · Cited by 47
Sex Differences in Drug-Induced Arrhythmogenesis
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Azimilide vs. placebo and sotalol for persistent atrial fibrillation: the A-COMET-II (Azimilide-CardiOversion MaintEnance Trial-II) trial
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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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