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 of 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.
|
| |
RYTHMOL SR SUMMARY
RYTHMOL SR (propafenone hydrochloride) is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration.
RYTHMOL SR is indicated to prolong the time to recurrence of symptomatic atrial fibrillation in patients without structural heart disease.
The use of RYTHMOL SR in patients with permanent atrial fibrillation or in patients exclusively with atrial flutter or PSVT has not been evaluated. RYTHMOL SR should not be used to control ventricular rate during atrial fibrillation.
The effect of RYTHMOL SR on mortality has not been determined (see black box WARNINGS).
|
|
NEWS HIGHLIGHTS
Published Studies Related to Rythmol SR (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.
Efficacy and tolerability of oral propafenone versus quinidine in the treatment of recent onset atrial fibrillation: A randomized, prospective study. [2009]
BACKGROUND: A prospective, randomized study was conducted to evaluate the efficacy and tolerability of oral propafenone and quinidine for the conversion of paroxysmal atrial fibrillation (AF)... CONCLUSIONS: Although both drugs revealed the same effectiveness, the conversion to sinus rhythm in the group treated with propafenone was observed more quickly despite the longer paroxysmal AF episode duration.
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.
Clinical Trials Related to Rythmol SR (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.
Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias [Recruiting]
A randomized, parallel, open study comparing catheter ablation versus antiarrhythmic drugs
for outflow tract ventricular arrhythmias
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.
Reports of Suspected Rythmol SR (Propafenone) Side Effects
Drug Ineffective (8),
Asthenia (6),
Fall (5),
Product Quality Issue (5),
Headache (4),
Balance Disorder (4),
Cerebrovascular Accident (4),
Sensory Loss (3),
Fatigue (3),
Dizziness (3), more >>
|
|
|
|
Page last updated: 2010-10-05
|
