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      Amlodipine and the Total Ischemic Burden: Circadian Anti-Ischemia Program in Europe (CAPE) Trial – Methodology, Safety and Toleration

      Cardiology

      S. Karger AG

      Total ischemic burden, Silent ischemia, Myocardial ischemia, Amlodipine, toleration, Amlodipine, safety

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          Abstract

          The Circadian Anti-Ischemic Program in Europe (CAPE) trial was a large, multinational trial, taking place in ten countries and involving over 100 investigators. It was a double-blind, parallel, randomized, placebo-controlled trial comparing once-daily amlodipine with placebo in chronic stable angina pectoris. It consisted of two phases, the first being a 2-week, single-blind, placebo run-in phase during which stable doses of anti-anginal drugs were maintained (65% of patients were receiving β-blockers), and the second an 8-week active treatment phase in which patients received either amlodipine or placebo, 5 mg once daily, for the first 4 weeks, increasing to 10 mg once daily for the second 4 weeks. Patients were randomized in a ratio of 2 patients receiving amlodipine to each patient receiving placebo. Out of an initial 1,160 patients screened, 315 entered the study, with 250 having complete efficacy-evaluable data. Patients were included if they experienced ≧ 4 ambulatory ECG ischemic episodes (≧ 1 mm ST-segment depression for > 1 min) and/or ≧ 20 min total ischemia time over 48 h. Data were obtained on the total frequency of ST-segment depression events, the ischemia area (ST-segment depression integral), the ischemic time and peak ST-segment depression. Patient diary information on angina attack rate and nitroglycerin tablet consumption was also collected. Patients in both groups were compared for age, blood pressure, heart rate, duration of angina and baseline ischemia at entry. Amlodipine and placebo had similar safety profiles, with 17.3% of amlodipine patients recording adverse events, compared with 13.3% of placebo patients. Angina pectoris was noted as a complaint by 2% of patients receiving amlodipine, compared with 3.5% receiving placebo. Edema was noted in 5.4% of amlodipine patients and 1.8% of placebo patients and headache was reported by 2.5% of amlodipine patients and 0.9% of placebo patients. In general, complaints were not severe and the withdrawal rate was low (amlodipine 2%, placebo 4%). None of the above differences was statistically significant. In conclusion, the baseline demographic and ischemic profiles for patients receiving either amlodipine or placebo were similar. Amlodipine was very well tolerated, as shown by a safety profile similar to that of placebo and a low withdrawal rate from the study.

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          Author and article information

          Journal
          CRD
          Cardiology
          10.1159/issn.0008-6312
          Cardiology
          S. Karger AG
          978-3-8055-6092-4
          978-3-318-01938-4
          0008-6312
          1421-9751
          1994
          1994
          19 November 2008
          : 85
          : Suppl 2
          : 24-30
          Affiliations
          Division of Cardiology, Ciiniques Universitaires St. Luc, Belgium
          Article
          177044 Cardiology 1994;85:24–30
          10.1159/000177044
          7736484
          © 1994 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: 7
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