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      Review of European Clinical Experience with Fenofibrate

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          Abstract

          Since the introduction of fenofibrate to European clinical practice in 1975, some 6.5 million patient-years of experience in the treatment of hyperlipidemia have been accumulated. A review of results of clinical trials shows fenofibrate to have a broad spectrum of lipid-lowering activity, reducing the total cholesterol level by 20–25% in type Ha patients and triglycerides by 40–60% in type lib and IV patients. High levels of low-density lipoprotein cholesterol are reduced and, where low at baseline, high-density lipoprotein levels are increased. An associated activity is a 10–28% reduction in serum uric acid levels. Adverse reactions in the mostly open clinical trials ranged from 2–15 %; mild gastrointestinal problems dominated, and occurred with much the same frequency in the placebo-treated groups of controlled trials. There are also reports of fatigue, headache, loss of libido, dizziness, and insomnia. Some excess of skin rash emerged as the only statistically significant unwanted clinical effect in one placebo-controlled trial. Biochemically, there are occasional fluctuations in serum transaminase values, while γ-glucuronyl transferase and alkaline phosphatase are often decreased, all without apparent clinical significance. Lithogenicity of the bile is often increased above pretreatment levels, but there is no evidence from trials or postmarketing surveillance that the use of fenofibrate is associated with an increase of gallstone formation.

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          Author and article information

          Journal
          CRD
          Cardiology
          10.1159/issn.0008-6312
          Cardiology
          S. Karger AG
          978-3-8055-5023-9
          978-3-318-00099-3
          0008-6312
          1421-9751
          1989
          1989
          12 November 2008
          : 76
          : Suppl 1
          : 1-13
          Affiliations
          Laboratoires Fournier, Centre de Recherches de Daix, Fontaine-lès-Dijon, France
          Article
          174541 Cardiology 1989;76:1–13
          10.1159/000174541
          2653620
          © 1989 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: 13
          Categories
          A New Era of Lipid-Lowering Drug Alternatives: Session 1

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