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Propafenone (Propafenone Hydrochloride) - Summary

 

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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.

 

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

  • paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.

  • paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms.

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.

PROPAFENONE NEWS HIGHLIGHTS

Published Studies Related to Propafenone

Propafenone for the prevention of atrial tachyarrhythmias after cardiac surgery: a randomized, double-blind placebo-controlled trial. [2008.07]

Propafenone for the Prevention of Atrial Tachyarrhythmias After Cardiac Surgery: A Randomized, Double-blind Placebo-controlled Trial. [2008.01.02]

Propafenone added to ibutilide increases conversion rates of persistent atrial fibrillation. [2006.05]

Utility of adjunctive single oral bolus propafenone therapy in patients with atrial defibrillators. [2006.03]

Comparison of intravenous ibutilide vs. propafenone for rapid termination of recent onset atrial fibrillation. [2005.12]

more>>

Clinical Trials Related to Propafenone

A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation [Recruiting]

Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) [Completed]

Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) [Completed]

High Intensity Focused Ultrasound (HIFU) Ablation System Study [Suspended]

A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation [Recruiting]

more>>

Page last updated: 2008-06-22

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