Copyright © 2002 by the European Society of Cardiology.
Sulodexide in the treatment of intermittent claudication. Results of a randomized, double-blind, multicentre, placebo-controlled study
a Cardiovascular Department, Division of Angiology and Blood Coagulation, University Hospital S. Orsola-Malpighi, Bologna, Italy
b ASL cittá di Bologna, Angiology Service and Day Hospital ‘Mengoli’ Bologna, Italy
c Department of Internal Medicine, Division of Internal and Cardiovascular Medicine, University of Perugia, Perugia, Italy
d Medical Department, Alfa Wassermann, Bologna, Italy
revised September 6, 2001; accepted September 12, 2001
Abstract
Aims Patients with peripheral arterial obstructive disease require treatment to prevent major cardiovascular events and to relieve intermittent claudication. The walking performance of peripheral arterial obstructive disease patients was used to evaluate the usefulness of sulodexide, a glycosaminoglycan containing fast moving heparin and dermatan sulphate.
Methods and Results A randomized, multicentre, double-blind, placebo-controlled study was performed in 286 patients with Leriche-Fontaine stage II peripheral arterial obstructive disease. Patients received placebo (n=143) or sulodexide (n=143) for 27 weeks. The primary end-point was the doubling of the pain-free walking distance at the end of treatment, and this was achieved by 23·8% of patients treated with sulodexide and 9·1% of those on placebo (P=0·001). The pain-free walking distance increased on average (±SE) by 83·2±8·6m (+64·7% from baseline) with sulodexide and 36·7±6·2m (+29·9% from baseline) with placebo (P=0·001). The maximum walking distance increased by 142·3±15·8m (+76·0% from baseline) and 54·5±8·4m (+27·9% from baseline) (P<0·001), respectively. Results for patients with type II diabetes were similar to those for non-diabetic patients. Plasma fibrinogen decreased with sulodexide, but increased with placebo.
Conclusion Sulodexide improved the walking ability of peripheral arterial obstructive disease patients to a significantly greater extent than placebo, with a concurrent significant decrease in fibrinogen. The treatment was well tolerated. Copyright 2001 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved.
Key Words: Peripheral artery disease, claudication, fibrinogen, sulodexide
f1 Correspondence: Sergio Coccheri, Cardiovascular Department, Division of Angiology and Blood Coagulation, University Hospital S. Orsola-Malpighi, Via Massarenti, 9-40138, Bologna, Italy.
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