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      Randomized Controlled Trial on the Efficacy and Safety of Atorvastatin in Patients with Type 2 Diabetes on Hemodialysis (4D Study): Demographic and Baseline Characteristics

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          Abstract

          Patients with type 2 diabetes on dialysis are at a substantially increased risk of cardiovascular and cerebrovascular diseases. Dyslipidemia characterized by moderately elevated low-density lipoprotein cholesterol and high triglycerides and low high-density lipoprotein cholesterol levels is common in this population. We hypothesized that 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors would reduce vascular morbidity and mortality in this patient group. The ‘Deutsche Diabetes Dialyse Studie’ (4D study) is a prospective, randomized, double-blind study involving 178 dialysis centers throughout Germany. Between March 1998 and October 2002, 1,255 patients were randomized to either atorvastatin 20 mg or placebo; 677 men and 578 women, aged 30–83 years, have been enrolled. The study will be terminated as soon as the predefined number of 424 patients with primary combined end points (i.e., cardiovascular death, nonfatal myocardial infarction, or fatal/nonfatal stroke) will have occurred. The total cohort had the following characteristics at baseline: the mean age was 65.7 years, 54% were men, 89% had a history of hypertension, 21% had coronary artery disease, 17.8% had a history of stroke or a transient ischemic attack, and 45% suffered from peripheral arterial disease. The mean time interval between the diagnosis of diabetes and the onset of dialysis was 17.4 years. On average, the patients were on hemodialysis for 8.3 months. Mean lipid and lipoprotein levels were: total cholesterol 219 ± 43 mg/dl, low-density lipoprotein cholesterol 126 ± 30 mg/dl, high-density lipoprotein cholesterol 36 ± 13 mg/dl, and triglycerides 264 ± 167 mg/dl. The results of the study will provide important information on the efficacy and safety of atorvastatin to support its use in patients with an impaired renal function who are at a high risk of vascular morbidity and mortality.

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          Author and article information

          Journal
          KBR
          Kidney Blood Press Res
          10.1159/issn.1420-4096
          Kidney and Blood Pressure Research
          S. Karger AG
          1420-4096
          1423-0143
          2004
          September 2004
          08 September 2004
          : 27
          : 4
          : 259-266
          Affiliations
          aDivision of Nephrology, University Clinic, Würzburg, Germany; bClinical Institute of Medical and Chemical Laboratory Diagnostics, University and General Hospital, Graz, Austria; cDepartment of Medical Biometrics and Statistics, University Hospital, Freiburg, dKuratorium für Dialyse und Transplantation, Berlin, eDialysezentrum, Pirmasens, fDepartment of Nephrology, Städtisches Klinikum, Karlsruhe, gDialysezentrum Pforzheim, Pforzheim, hStädtisches Klinikum Schwabing, München, iClinical Research Department, Pfizer Ltd., Karlsruhe, and jDivision of Nephrology, University Hospital, Heidelberg, Germany
          Article
          80241 Kidney Blood Press Res 2004;27:259–266
          10.1159/000080241
          15316128
          © 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
          Tables: 3, References: 45, Pages: 8
          Product
          Self URI (application/pdf): https://www.karger.com/Article/Pdf/80241
          Categories
          Original Paper

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