What question did this study set out to answer?

To evaluate the efficacy and safety of oral dofetilide for pharmacological cardioversion and the 1-year maintenance of sinus rhythm in patients with chronic atrial fibrillation or atrial flutter.

November 7, 2000CirculationOpen Access

Efficacy and Safety of Oral Dofetilide in Converting to and Maintaining Sinus Rhythm in Patients With Chronic Atrial Fibrillation or Atrial Flutter

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Why the study?

Does dofetilide improve conversion to and maintenance of sinus rhythm in patients with chronic atrial fibrillation or atrial flutter?

Key Points

To evaluate the efficacy and safety of oral dofetilide for pharmacological cardioversion and the 1-year maintenance of sinus rhythm in patients with chronic atrial fibrillation or atrial flutter.
Double-blind, multicenter, placebo-controlled randomized trial involving 325 patients with atrial fibrillation or atrial flutter.
Participants were randomized to placebo or dofetilide at 125, 250, or 500 µg twice daily, with doses adjusted for QTc interval and calculated creatinine clearance.
Patients who successfully cardioverted pharmacologically or electrically were followed for 1 year to assess sinus rhythm maintenance.
Pharmacological cardioversion rates were 6.1%, 9.8%, and 29.9% for 125, 250, and 500 µg dofetilide, respectively, versus 1.2% for placebo (P=0.015 for 250 µg and P<0.001 for 500 µg).
Among 250 cardioverted patients, the probability of remaining in sinus rhythm at 1 year was 0.40, 0.37, and 0.58 for 125, 250, and 500 µg dofetilide versus 0.25 for placebo (P=0.001 for 500 µg vs placebo).
Safety events on active drug included torsade de pointes in 2 patients (0.8%) and 1 proarrhythmic sudden cardiac death (0.4%).

Structured PICO

Does dofetilide improve conversion to and maintenance of sinus rhythm in patients with chronic atrial fibrillation or atrial flutter?

Population

325 patients with chronic atrial fibrillation (AF) or atrial flutter (AFl)

Intervention

Dofetilide 125, 250, or 500 microgram twice daily (dosages adjusted for QTc response and calculated creatinine clearance)

Comparator

Placebo twice daily

Outcome

Converting atrial fibrillation (AF) or atrial flutter (AFl) to sinus rhythm (SR) and maintaining SR for 1 year

Dofetilide is effective for pharmacological cardioversion and maintenance of sinus rhythm in AF/AFl, but requires careful dose adjustment and in-hospital initiation due to proarrhythmic risk.

Discussion

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Implication

Dofetilide 500 μg aids cardioversion and sinus rhythm maintenance in chronic AF/AFl; confirms RCT efficacy but requires inpatient initiation for proarrhythmic monitoring.

Cite This Study

Singh et al. (2000) studied this question.

synapsesocial.com/papers/6a7cdb1b6e07fdc915aeb16b https://doi.org/10.1161/01.cir.102.19.2385

Topics

Persistent AF management Atrial fibrillation Anticoagulation in AF

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Implication

Dofetilide 500 μg aids cardioversion and sinus rhythm maintenance in chronic AF/AFl; confirms RCT efficacy but requires inpatient initiation for proarrhythmic monitoring.

Efficacy and Safety of Oral Dofetilide in Converting to and Maintaining Sinus Rhythm in Patients With Chronic Atrial Fibrillation or Atrial Flutter

Key Points

Structured PICO

Discussion

Implication

Cite This Study

Topics

Efficacy and Safety of Oral Dofetilide in Converting to and Maintaining Sinus Rhythm in Patients With Chronic Atrial Fibrillation or Atrial Flutter

Key Points

Structured PICO

Discussion

Implication

Cite This Study

Also Consider

Topics

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