BOX WARNING Mortality:
In the National Heart, Lung and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multi-center, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than six days but less than two years previously, an increased rate of death or reversed cardiac arrest rate (7.7%; 56/730) was seen in patients treated with encainide or flecainide (Class 1C antiarrhythmics) compared with that seen in patients assigned to placebo (3.0%; 22/725). The average duration of treatment with encainide or flecainide in this study was ten months.
The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) or other antiarrhythmic drugs is uncertain, but at present it is prudent to consider any 1C antiarrhythmic to have a significant risk in patients with structural heart disease. Given the lack of any evidence that these drugs improve survival, antiarrhythmic agents should generally be avoided in patients with non-life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs.
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PROPAFENONE SUMMARY
PROPAFENONE HYDROCHLORIDE TABLETS
Propafenone hydrochloride is an antiarrhythmic drug. Propafenone has some structural similarities to beta-blocking agents.
In patients without structural heart disease, propafenone is indicated to prolong the time to recurrence of
As with other agents, some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional AV refractory period is recommended.
The use of propafenone in patients with chronic atrial fibrillation has not been evaluated. Propafenone should not be used to control ventricular rate during atrial fibrillation.
Propafenone hydrochloride tablets are also indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of propafenone, its use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic, and any use of the drug should be reserved for patients in whom, in the opinion of the physician, the potential benefits outweigh the risks.
Initiation of propafenone treatment, as with other antiarrhythmics used to treat life-threatening ventricular arrhythmias, should be carried out in the hospital.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular or atrial arrhythmias.
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NEWS HIGHLIGHTS
Published Studies Related to Propafenone
Comparative bioavailability of propafenone after administration of a magistral suspension vs. commercial tablets in healthy volunteers. [2009]
Propafenone (CAS 34183-22-7) is an effective antiarrhythmic drug used in children, although in some countries no specific pediatric formulation is available.
Propafenone for the prevention of atrial tachyarrhythmias after cardiac surgery: a randomized, double-blind placebo-controlled trial. [2008.07]
We studied the efficacy of propafenone in preventing atrial tachyarrhythmias after cardiac surgery, and the possible relationships between CYP2D6 polymorphism and the efficacy, pharmacokinetics, and tolerability of propafenone. One hundred and sixty patients were randomized (double blind) to receive propafenone (n= 78) or placebo (n= 82) for 1 week after cardiac surgery.
Propafenone for the Prevention of Atrial Tachyarrhythmias After Cardiac Surgery: A Randomized, Double-blind Placebo-controlled Trial. [2008.01.02]
We studied the efficacy of propafenone in preventing atrial tachyarrhythmias after cardiac surgery, and the possible relationships between CYP2D6 polymorphism and the efficacy, pharmacokinetics, and tolerability of propafenone. One hundred and sixty patients were randomized (double blind) to receive propafenone (n= 78) or placebo (n= 82) for 1 week after cardiac surgery.
Propafenone added to ibutilide increases conversion rates of persistent atrial fibrillation. [2006.05]
CONCLUSION: Concurrent administration of propafenone plus ibutilide for pharmacological cardioversion of persistent AF is safe and more effective than ibutilide alone.
Utility of adjunctive single oral bolus propafenone therapy in patients with atrial defibrillators. [2006.03]
CONCLUSION: Adjunctive use of single oral bolus propafenone is safe and effective in patients with an ICD and improves patient tolerance of device-based AF therapy.
Clinical Trials Related to Propafenone
A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation [Recruiting]
PS-023 is a randomized controlled clinical study. The purpose of this study is to determine
whether this new catheter system (Arctic Front CryoAblation Catheters, FlexCath Steerable
Sheath) is safe and effective for the treatment of paroxysmal atrial fibrillation, as well as
to see if this treatment is better compared to a medication. This catheter system uses
freezing energy, cryoablation, to ablate (destroy) abnormal tissue in or near the pulmonary
veins. A refrigerant (cooling material) is delivered within the catheter to cool the
catheter tip. This freezes and destroys the cells at the entrance to the pulmonary veins. If
the atrial fibrillation comes from somewhere else in the heart, another catheter, the Freezor
MAX, will be used to freeze that area. This experimental catheter also uses freezing to
ablate abnormal tissue. Many atrial fibrillation patients also have another arrhythmia
called atrial flutter. In order to treat or to prevent atrial flutter after the procedure,
the Freezor MAX catheter may be used to freeze the cells in the area of the heart where
atrial flutter starts.
Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) [Completed]
To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals
who had survived one episode of out-of-hospital cardiac arrest.
Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) [Completed]
To compare two standard treatment strategies for atrial fibrillation: ventricular rate
control and anticoagulation vs. rhythm control and anticoagulation.
High Intensity Focused Ultrasound (HIFU) Ablation System Study [Suspended]
The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is
effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best
medical therapy with FDA approved antiarrhythmic drugs.
A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation [Recruiting]
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Page last updated: 2009-10-20
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