BOX WARNING
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 SUMMARY
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.
|
NEWS HIGHLIGHTS
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
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.
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.
Comparative Study of Flecainide CR and Placebo in the Early Treatment of Atrial Fibrillation. [Terminated]
The purpose of the study is to assess the efficacy of flecainide controlled release (CR) in
the prevention of recurrent AF during 9 months of active treatment compared to placebo in
patients with only one documented AF episode.
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.
Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias [Recruiting]
The study evaluates 3 different populations:
It is an open, randomized, parallel-group study comparing the effectiveness of intravenous
(iv) ajmaline with currently used antiarrhythmic drugs in the acute treatment of :
1. recent-onset atrial fibrillation versus iv flecainide
2. sustained monomorphous ventricular tachycardia versus iv procainamide
The study also evaluates in an open, randomized, crossover study, the use of iv ajmaline
versus iv flecainide in the diagnosis of Brugada syndrome
|
|
|
|
Page last updated: 2008-01-02
|
