Mortality: Flecainide was included in the National Heart Lung and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, 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 excessive mortality or non-fatal cardiac arrest rate was seen in patients treated with flecainide compared with that seen in patients assigned to a carefully matched placebo-treated group. This rate was 16/315 (5.1%) for flecainide and 7/309 (2.3%) for the matched placebo. The average duration of treatment with flecainide in this study was ten months.
The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) is uncertain, but at present, it is prudent to consider the risks of Class IC agents (including flecainide), coupled with the lack of any evidence of improved survival, generally unacceptable in patients without life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs.
Ventricular Pro-Arrhythmic Effects in Patients with Atrial Fibrillation/Flutter: A review of the world literature revealed reports of 568 patients treated with oral flecainide for paroxysmal atrial fibrillation/flutter (PAF). Ventricular tachycardia was experienced in 0.4% (2/568) of these patients. Of 19 patients in the literature with chronic atrial fibrillation (CAF), 10.5% (2) experienced VT or VF. FLECAINIDE IS NOT RECOMMENDED FOR USE IN PATIENTS WITH CHRONIC ATRIAL FIBRILLATION. Case reports of ventricular proarrhythmic effects in patients treated with flecainide for atrial fibrillation/flutter have included increased PVCs, VT, ventricular fibrillation (VF), and death.
As with other Class I agents, patients treated with flecainide for atrial flutter have been reported with 1:1 atrioventricular conduction due to slowing the atrial rate. A paradoxical increase in the ventricular rate also may occur in patients with atrial fibrillation who receive flecainide. Concomitant negative chronotropic therapy such as digoxin or beta-blockers may lower the risk of this complication.
FLECAINIDE ACETATE TABLETS, USP
Flecainide Acetate Tablets, USP are an antiarrhythmic drug available in tablets of 50, 100 or 150 mg for oral administration.
In patients without structural heart disease, Flecainide Acetate Tablets, USP are indicated for the prevention of:
- paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms
- paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms
- Flecainide Acetate Tablets, USP are also indicated for the prevention of documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening.
Use of Flecainide Acetate Tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic.
Because of the proarrhythmic effects of Flecainide Acetate Tablets, USP, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks.
Flecainide Acetate Tablets, USP should not be used in patients with recent myocardial infarction. (See Boxed WARNINGS.)
Use of Flecainide Acetate Tablets, USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See Boxed WARNINGS.)
As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide acetate favorably affects survival or the incidence of sudden death.
Published Studies Related to Flecainide
Flecainide for the treatment of chronic neuropathic pain: a Phase II trial. [2007.12]
BACKGROUND: Management of neuropathic pain is challenging. Medications that interfere with sodium channel transport, such as lidocaine, mexilitene and flecainide, are promising as analgesics. OBJECTIVE: In a general population of patients with a working diagnosis of neuropathic pain, whether if flecainide produces enough of an improvement in pain to warrant further clinical study is determined... CONCLUSIONS: Flecainide produced a 30% response rate. Response in this study was defined to be highly relevant and clinically significant reduction in pain. The drug merits study in a randomized placebo-controlled trial. Palliative Medicine 2007; 21: 667-672.
Dose-response effect of flecainide in patients with symptomatic paroxysmal atrial fibrillation and/or flutter monitored with trans-telephonic electrocardiography: a multicenter, placebo-controlled, double-blind trial. [2007.03]
CONCLUSIONS: This study indicated that flecainide exerted a significant dose-dependent effect on the prevention of symptomatic PAF/PAFL recurrence and showed that there was no inter-ethnic difference in the clinical effect of flecainide in patients with PAF/PAFL.
Multicenter automatic defibrillator implantation trial-cardiac resynchronization therapy (MADIT-CRT): design and clinical protocol. [2005.10]
The planned MADIT-CRT trial is designed to determine if CRT-D will reduce the risk of mortality and HF events by approximately 25% in subjects with ischemic (NYHA class I-II) and non-ischemic (NYHA class II) cardiomyopathy, left ventricular dysfunction (EF<or=0.30), and prolonged intraventricular conduction (QRS duration>or=130 ms)..
Clinical Trials Related to Flecainide
Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia [Not yet recruiting]
The purpose of this study is to test whether the addition of oral flecainide to standard
therapy will reduce cardiac events compared to placebo plus standard therapy in patients
with Catecholaminergic Polymorphic Ventricular Tachycardia.
To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation [Completed]
The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation
with controlled release flecainide on patient's quality of life.
Vernakalant Versus Flecainide: Atrial Contractility [Not yet recruiting]
Atrial fibrillation (AF) is associated with decreased atrial contractility which is
associated with stroke. Decreased contractility becomes apparent after cardioversion of
atrial fibrillation, a short period (weeks) during which stroke risk is increased. Improved
contractility immediately after cardioversion may prevent arrhythmia progression. In
addition, it may reduce the stroke risk. Vernakalant is a new antiarrhythmic drug able to
convert atrial fibrillation to sinus rhythm and at the same time increase atrial
contractility. The latter has not yet been shown in humans and is subject of the present
investigation. Our hypothesis is that in humans the contractility of the atria is higher
after administration of vernakalant compared to flecainide. If indeed vernakalant improves
atrial contractility after cardioversion further studies into the effect on long-term
arrhythmia progression and stroke prevention may follow.
Cytochrome P450 2D6 (CYP 450 2D6) Genotype and Flecainide Efficacy [Not yet recruiting]
The determination of the 2D6 genotype will enable us to determine the way flecainide is
metabolized by the liver. Some individuals are poor metabolizers and some individuals are
extensive metabolizers of the drug. This will also determine which patients will benefit
from the drug.
Flecainide in Treating Patients With Chronic Neuropathic Pain [Completed]
RATIONALE: Flecainide therapy may help patients with neuropathic pain live more comfortably.
PURPOSE: Phase II trial to study the effectiveness of flecainide in treating patients with
chronic neuropathic pain from cancer or AIDS.
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Flecainide has an overall score of 10. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
Flecainide review by 72 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || Atrial Fibulation|
|Dosage & duration:|| || 150mg. taken daily for the period of 14 years|
|Other conditions:|| || none|
|Other drugs taken:|| || coumadin|
|Benefits:|| || The treatment benefits were that the incidence of arrhythmia was drastically
reduced and the duration of episodes was also drastically reduced. I could
go for days, weeks, and months without having any episodes. When I do have
an episode, it is mild and short lived.|
|Side effects:|| || There were no side effects that I can recall at the outset and there are no
side effects now.|
|Comments:|| || I was initially prescribed Beta Blockers. These caused great lethargy
and dizzyness. I was tired and had no energy for even the slightest efforts.
After trying several Beta Blockers, I was switched to Calcium Channel
Blockers. I did not feel well with these either. Finally I was prescribed
Flecainide which is evidently not a very popular choice. It seems to have
worked well for me.|
Page last updated: 2008-01-02