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      Rosuvastatin-Induced Arrest in Progression of Renal Disease

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          Abstract

          Preclinical and limited clinical data suggest that statins decrease the progressive decline in renal function that occurs in patients with renal disease. Pooled analysis of data obtained from a population of hyperlipidemic patients enrolled in the rosuvastatin (Crestor<sup>®</sup>) clinical development program permitted assessment of its effects on renal function both early and later in the course of treatment. Study participants were initially included in controlled clinical trials that evaluated the lipid-lowering efficacy and safety of rosuvastatin when compared with placebo or other lipid-lowering agents (i.e., atorvastatin, simvastatin, pravastatin, cholestyramine, fenofibrate or extended-release niacin). The median duration of treatment with the various doses of statins in these trials was approximately 8 weeks. Following completion of a controlled clinical trial, patients were permitted to enter an open-label extension trial and received rosuvastatin treatment. These data permitted assessment of renal function in a diverse group of over 10,000 patients who received rosuvastatin in its recommended dose range (5–40 mg) for up to 3.8 years. Mean serum creatinine concentrations were lower when compared with baseline both early and later in the course of rosuvastatin treatment. In contrast, no change in mean serum creatinine was observed with placebo. Mean glomerular filtration rates (GFR) predicted from the Modification of Diet in Renal Disease (MDRD) equation were higher when compared with baseline both early and later in the course of rosuvastatin treatment. No change in GFR was observed in the placebo group. Among patients who received long-term rosuvastatin treatment (≧96 weeks), GFR was unchanged or tended to increase, rather than decrease, when compared with baseline irrespective of age, gender, hypertensive or diabetic status, level of renal function (GFR ≧60 vs. <60 ml/min/1.73 m<sup>2</sup>) at entry or urine dipstick protein status prior to or during the period of treatment. These findings suggest that rosuvastatin may arrest the progression of renal disease.

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          Most cited references 10

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          Prevention of coronary heart disease in clinical practice Recommendations of the Second Joint Task Force of European and other Societies on Coronary Prevention

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              Progression of chronic renal failure.

               Hsin-Chieh Yu (2003)
              Chronic renal failure is characterized by a persistently abnormal glomerular filtration rate. The rate of progression varies substantially. Several morphologic features are prominent: fibrosis, loss of native renal cells, and infiltration by monocytes and/or macrophages. Mediators of the process include abnormal glomerular hemodynamics, hypoxia, proteinuria, hypertension, and several vasoactive substances (ie, cytokines and growth factors). Several predisposing host factors may also contribute to the process. Treatments to delay progression are aimed at treating the primary disease and at strictly controlling the systemic blood pressure and proteinuria. The role of antihypertensive agents, statins, and use of other maneuvers such as protein restriction and novel approaches are also discussed herein.
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                Author and article information

                Journal
                CRD
                Cardiology
                10.1159/issn.0008-6312
                Cardiology
                S. Karger AG
                0008-6312
                1421-9751
                2004
                April 2004
                28 April 2004
                : 102
                : 1
                : 52-60
                Affiliations
                aCleveland Clinic Foundation, Cleveland, Ohio, bAstraZeneca LP, Wilmington, Del., USA, and cAstraZeneca, Macclesfield, UK
                Article
                77704 Cardiology 2004;102:52–60
                10.1159/000077704
                15073451
                © 2004 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
                Figures: 1, Tables: 6, References: 35, Pages: 9
                Categories
                Clinical Pharmacology

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