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      Methodology for Clinical Trials with Antiarrhythmic Drugs to Prevent Cardiac Death: US Experience

      Cardiology

      S. Karger AG

      Ventricular tachycardia, Ventricular arrhythmias, Myocardial infarction, Clinical trials

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          Abstract

          Sudden cardiac death is a massive public health problem that claims almost a half million lives a year in the United States. Several high-risk groups have been identified: (1) survivors of cardiac arrest; (2) patients with recurrent sustained ventricular tachycardia; (3) survivors of myocardial infarction (MI) who have more than 10 ventricular premature depolarizations (VPD) per hour or repetitive VPD; and (4) patients with class III or IV congestive heart failure (CHF) and unsustained ventricular tachycardia. The effects of open label drug treatment have been tested in survivors of cardiac arrest or sustained ventricular tachycardia using either electrophysiologic studies or 24-hour ECG recordings and exercise testing. Patients classified as drug responders using these methods have a lower mortality rate during follow-up than do those classified as nonresponders. This result is difficult to interpret. The test procedures may be identifying effective drugs, or alternatively, drug testing may identify high- and low-risk groups even though the drugs have no effect on survival. Recently, study designs have been proposed for conducting controlled trials in patients with malignant arrhythmias.

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          Author and article information

          Journal
          CRD
          Cardiology
          10.1159/issn.0008-6312
          Cardiology
          S. Karger AG
          978-3-8055-4629-4
          978-3-318-01764-9
          0008-6312
          1421-9751
          1987
          1987
          11 November 2008
          : 74
          : Suppl 2
          : 40-56
          Affiliations
          Division of Cardiology, Department of Medicine, Columbia University, and The Arrhythmia Control Unit, The Columbia-Presbyterian Medical Center, New York, N.Y., USA
          Article
          174286 Cardiology 1987;74:40–56
          10.1159/000174286
          3621278
          © 1987 S. Karger AG, Basel

          Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

          Page count
          Pages: 17
          Categories
          Paper

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