Evaluation of pharmacological and device therapy for the management of life-threatening arrhythmias

R. J. Myerburg, R. Mitrani, Jr Interian A., J. Simmons, A. Castellanos

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Abstract

During the past two decades, a large number of controlled clinical trials of various forms of antiarrhythmic therapy have been designed and carried out. The application of the results of these trials is dependent upon the study designs and the degree to which outcomes can be generalized and applied to clinical practice. For the interpretation of clinical trials, five factors are essential: (1) insight into the specific endpoints measured and the limitation of outcomes data; (2) weighing up the difference between placebo-controlled trials and trials which incorporate a positive control (comparative) therapy; (3) appreciating the meaning of intention-to-treat analysis and recognition that on-therapy analysis may help interpretation; (4) understanding the difference between relative reduction of event rates (efficacy) and absolute benefits (efficiency); (5) evaluating the impact of various trials on the population at risk for a given outcome event. This paper discusses the importance and limitations of each of these elements of trials strategy, with the aim of providing the reader with an insight into the integration of new data into the practise of cardiology generally and for the management of arrhythmias specifically.

Original languageEnglish (US)
Pages (from-to)C21-C30
JournalEuropean Heart Journal, Supplement
Volume1
Issue numberC
StatePublished - Jan 1 1999

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Keywords

  • Antiarrhythmic drugs
  • Implantable cardiac defibrillators
  • Sudden cardiac death
  • Ventricular arrhythmias

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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