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      Sustained-Release IS-5-MN in the Treatment of Coronary Heart Disease

      Cardiology

      S. Karger AG

      Elantan® Long, IS-5-MN, sustained-release, Angina pectoris, Exercise tolerance test, Plasma levels

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          Abstract

          In a double-blind, randomized cross-over study the antianginal efficacy and tolerability of Elantan® Long (50 mg sustained-release IS-5-MN) were compared with a 80-mg sustained-release (s.r.) IS-5-MN formulation. 28 patients were enrolled in the study, which consisted of a 3-day washout period on placebo, an active treatment of 14 days (crossover after 7 days) and a final 3-day withdrawal period on placebo. Ergometric exercise tests with simultaneous ECG monitoring were carried out 2 and 10 h post administration (p.a.) on the last days of each period. Under 50 mg s.r. IS-5-MN the mean ST- segment depression under comparable load was reduced by 67% 2 h p.a. and by 70% 10 h p.a. The reduction under the 80 mg IS-5-MN form was about 76% 2 h p.a. and 78% 10 h p.a. Maximum workload, working capacity, duration of exercise, time to angina pectoris and time to ST-segment depression > 0.1 mV were markedly increased under therapy with each dosage. Comparisons between the medications revealed significant differences only in time to ST-segment depression > 0.1 mV and in ST-segment depression under maximum workload at 10 h p.a. which were increased more by the higher dosage. The incidence of anginal attacks decreased by almost 80% in the patients under both treatments. Ten patients under each dosage were completely freed from attacks. Adverse drug reactions occurred in 14 patients, 10 times under 80 mg s.r. IS-5-MN, 5 times under Elantan Long and twice under placebo. In two cases discontinuation of the study was necessary due to headache after IS-5-MN. Plasma levels of IS-5-MN (median without drop-outs) under steady state conditions under Elantan Long were of 361 ng/ml and 401 mg/ml 2 and 10 h p.a., respectively. For the 80-mg form 506 ng/ml and 647 mg/ml, respectively, were measured.

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          Author and article information

          Journal
          CRD
          Cardiology
          10.1159/issn.0008-6312
          Cardiology
          S. Karger AG
          978-3-8055-5486-2
          978-3-318-01618-5
          0008-6312
          1421-9751
          1991
          1991
          12 November 2008
          : 79
          : Suppl 2
          : 51-57
          Affiliations
          Kurklinik der LVA, Bad Münster am Stein, FRG
          Article
          174925 Cardiology 1991;79:51–57
          10.1159/000174925
          1760831
          © 1991 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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