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      Cardiovascular Mortality in Haemodialysis Patients Treated with Epoetin Beta – A Retrospective Study


      S. Karger AG

      End-stage renal failure, Mortality, Erythropoietin, Cardiovascular risk

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          Aims: Anaemia is a major risk factor in end-stage renal disease (ESRD) and leads to enhanced cardiac output and left-ventricular hypertrophy (LVH). Recombinant human erythropoietin (rhEPO) partially corrects anaemia and reduces LVH in ESRD. The current study retrospectively analysed mortality data from haemodialysis patients included in the clinical development database for epoetin-β. Methods: The unselected database, set up to monitor safety from clinical studies of epoetin-β, comprised 3,111 adult haemodialysis patients included in 17 clinical trials in the clinical development programme (1987–1994). 1,726 and 466 patients were treated for >1 and >2 years, respectively. Untreated control patients (n = 246) were available in two studies. Mortality was measured from fatal adverse event documentation. Results: The controlled studies showed an approximately 20% reduction in the mortality risk for epoetin-β versus controls after 1 year. For the overall patient population, all-cause mortality fell from a peak (after about 150 days) of about 10 to about 6 deaths per 100 patient-years in the 3rd year of treatment (p < 0.01). The proportion of deaths due to cardiovascular causes fell from 50 to 20–30% over 3 years. The decline in cardiovascular mortality could not be explained by changes in covariate distribution or by drop-outs. Conclusions: The cardiovascular mortality risk decreased over time in this population of ESRD patients. The beneficial effects of long-term anaemia correction by epoetin-β therapy was a likely cause of this favourable development.

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          Long-term cardiorespiratory effects of amelioration of renal anaemia by erythropoietin


            Author and article information

            S. Karger AG
            December 2000
            01 December 2000
            : 86
            : 4
            : 455-462
            Clinical Development, Roche Diagnostics, Mannheim, Germany
            45834 Nephron 2000;86:455–462
            © 2000 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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            Figures: 2, Tables: 5, References: 36, Pages: 8
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