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      Comparison of the Effects of Cilazapril and Captopril versus Placebo on Exercise Testing in Chronic Heart Failure Patients: A Double-Blind, Randomized, Multicenter Tria

      Cardiology

      S. Karger AG

      Angiotensin-converting enzyme inhibitors, Bicycle test, Captopril, Chronic heart failure, Cilazapril, Placebo, Walking test

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          Abstract

          In order to compare directly the efficacy of two different angiotensin-converting enzyme (ACE) inhibitors in terms of clinical status and exercise capacity, 443 patients with chronic heart failure (New York Heart Association classes II-IV) were randomized into a 24-week double-blind study to receive cilazapril (CLZ) 1-2.5 mg once daily (n = 221), captopril (CPT) 25-50 mg three times daily (n = 108), or placebo (PLA) for 12 weeks followed by CLZ 2.5 mg (n = 114) in addition to their standard heart failure therapy. The majority were New York Heart Association functional class II (56-62%), and the most frequent etiology of chronic heart failure was coronary heart disease (35-42%), followed by dilative cardiomyopathy (≈28%). Both ACE inhibitors prolonged the exercise tolerance test duration at all visits, and the effect at week 12 (CLZ 62.2 ± 7.5 s; CPT 73.1 ± 10.7 s) was significantly greater than after PLA (28.1 ± 12.2 s; p = 0.011 and p = 0.005, respectively). Furthermore, the distance walked during 6 min increased at all visits with ACE inhibitors (NS vs. PLA). CLZ was more effective in patients with the most impaired physical ability at baseline as defined by exercise tolerance test duration < 6 min (p = 0.0036 at week 12 and p = 0.0150 at week 24) and by walking test < 400 m (p = 0.0004 at week 12 and p = 0.0009 at week 24). Similar results were obtained with CPT for the walking test (p = 0.0369 at week 12 and p = 0.0142 at week 24). More patients on PLA tended to worsen their clinical status, as assessed by the New York Heart Association class or increased diuretic use. Furthermore, the mean body weight decreased significantly on CLZ, while it remained unchanged on PLA (p = 0.0335 for CLZ vs. PLA). The ACE inhibitor therapy was well tolerated, with dizziness (CLZ 10%; CPT 10.2%) and coughing (CLZ 9.0%; CPT 9.3%) most frequently reported. CLZ was well tolerated by-young and elderly patients, while CPT tended to cause more adverse events in elderly (63.0%) than in younger (48.4%) patients. Moreover, less patients discontinued treatment for adverse events with CLZ (5.4%) than with CPT (13.0%) or PLA (10.5%). Thus, the two ACE inhibitors CLZ and CPT at the dosages used were equally effective and both significantly better than PLA in prolonging the exercise tolerance test duration. This improvement was achieved with once daily dosing of CLZ as compared with three times daily administration of CPT and with a tendency for less adverse events with CLZ, particularly in older patients. The effect was maintained over 24 weeks and more pronounced in patients with the most impaired baseline physical ability. The similarity in the improvement of exercise tolerance with both ACE inhibitors suggests that this is probably a class effect, while the incidence in adverse events points toward differences in terms of tolerability of these compounds.

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          Author and article information

          Journal
          CRD
          Cardiology
          10.1159/issn.0008-6312
          Cardiology
          S. Karger AG
          978-3-8055-6154-9
          978-3-318-01937-7
          0008-6312
          1421-9751
          1995
          1995
          19 November 2008
          : 86
          : Suppl 1
          : 34-40
          Article
          176944 Cardiology 1995;86:34–40
          10.1159/000176944
          7614505
          © 1995 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.

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          Pages: 7
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