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Encainide--an updated safety profile.

J A Thomis1

  • 1Bristol-Myers Pharmaceutical Research, and Development Division, Brussels, Belgium.

Cardiovascular Drugs and Therapy
|June 1, 1990
PubMed
Summary

Encainide increases the risk of sudden death in patients with ventricular arrhythmias and a history of myocardial infarction, particularly those with reduced ejection fraction. It should be reserved for refractory or intolerant patients without structural heart disease.

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Area of Science:

  • Cardiology
  • Clinical Pharmacology

Background:

  • Encainide is an antiarrhythmic drug used for supraventricular and ventricular arrhythmias.
  • Previous safety evaluations have utilized various data sources, including retrospective and prospective studies.

Purpose of the Study:

  • To evaluate the safety and efficacy of encainide in patients with cardiac arrhythmias.
  • To identify patient subgroups at higher risk for adverse events during encainide therapy.

Main Methods:

  • Retrospective analyses of Bristol-Myers databases and adverse event reports.
  • Prospective analyses of major clinical trials including the Cardiac Arrhythmia Suppression Trial (CAST).

Main Results:

  • The CAST study revealed a higher incidence of sudden death or cardiac arrest with encainide compared to placebo in post-myocardial infarction patients.
  • Increased risk was observed in patients with low ejection fraction, frequent ventricular beats, or recent myocardial infarction.
  • Mortality in supraventricular arrhythmia patients was comparable to the general population.

Conclusions:

  • Encainide is associated with increased mortality in specific patient populations, particularly those with ventricular arrhythmias and structural heart disease.
  • The drug should be reserved for patients refractory or intolerant to other antiarrhythmic agents.
  • Careful risk-benefit assessment is crucial for patients without structural heart disease.

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