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Enkaid (Encainide Hydrochloride) - Summary

 

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BOX WARNING

Mortality

ENKAID was included 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 excessive mortality or nonfatal cardiac arrest rate was seen in patients treated with ENKAID compared with that seen in patients assigned to a carefully matched placebo-treated group. This rate was 40/415 (9.6%) for ENKAID and 15/416 (3.6%) for the matched placebo. The average duration of treatment with ENKAID 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 1c agents (including ENKAID), 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.

 

ENKAID SUMMARY

ENKAID®
(encainide HCl)

ENKAID® (encainide hydrochloride) is an antiarrhythmic drug supplied as 25 and 35 mg capsules for oral administration.

ENKAID is 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 ENKAID, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. ENKAID should not be used in patients with less severe ventricular arrhythmias, even if the patients are symptomatic.

Treatment with ENKAID should be initiated in a hospital. Patients should also be hospitalized at the time of a dose increase to 200 mg per day or above (see DOSAGE AND ADMINISTRATION).

The effects of ENKAID in patients with supraventricular arrhythmias and patients with recent myocardial infarction (except as described in the WARNINGS section) have not been adequately studied.

As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of ENKAID favorably affects survival or the incidence of sudden death.

ENKAID NEWS HIGHLIGHTS

Published Studies Related to Enkaid (Encainide)

Interaction of ischaemia and encainide/flecainide treatment: a proposed mechanism for the increased mortality in CAST I. [1995.12]

Interaction of baseline characteristics with the hazard of encainide, flecainide, and moricizine therapy in patients with myocardial infarction. A possible explanation for increased mortality in the Cardiac Arrhythmia Suppression Trial (CAST). [1994.12]

Circadian pattern of arrhythmic death in patients receiving encainide, flecainide or moricizine in the Cardiac Arrhythmia Suppression Trial (CAST). [1994.02]

Mortality following ventricular arrhythmia suppression by encainide, flecainide, and moricizine after myocardial infarction. The original design concept of the Cardiac Arrhythmia Suppression Trial (CAST). [1993.11.24]

Impact of food on the bioavailability of encainide. [1992.09]

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Clinical Trials Related to Enkaid (Encainide)

Cardiac Arrhythmia Pilot Study (CAPS) [Completed]

Cardiac Arrhythmia Suppression Trial (CAST) [Completed]

more>>

Page last updated: 2007-06-01

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