This document, supported by both the International Society for Clinical Hemorheology and the European Society for Clinical Hemorheology and Microcirculation, proposes new guidelines for hemorheolog ...

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New guidelines for hemorheological laboratory techniques

Due to various side effects of heparin, such as heparin-induced thrombocytopenia type I or type II, alternative anticoagulants are in clinical development to optimize the anticoagulant regimes in patients requiring low or high anticoagulation dosages. Sulodexide is a highly purified preparation containing a fast-moving heparin fraction as well as dermatansulfate. The pharmacological effects of sulodexide differ substantially from unfractionated heparin and are mainly characterized by a prolonged half-life and reduced effect on global coagulation and bleeding parameters. The lipolytic activity of sulodexide is increased in comparison to unfractionated heparin. Clinical studies demonstrate the safety and efficacy of sulodexide. Specially, oral administration leads to fibrinolytic activities in contrast to oral administration of other glycosaminoglycans. Thus, sulodexide releases tissue plasminogen activator and decreases fibrinogen levels as well as HDL and total cholesterol levels and blood viscosity. Clinical efficacy is demonstrated in peripheral arterial disease, cardiovascular events, in postphlebitic syndrome and on albuminuria in nephropathy.

Review of pharmacodynamics, pharmacokinetics, and therapeutic properites of sulodexide

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.

Sulodexide in the treatment of intermittent claudication. Results of a randomized, double-blind, multicentre, placebo-controlled study

Venous ulcers are still today one of the main socioeconomic problems of medical interest in terms of prevalence, morbidity, and costs to the health service. In the past, various studies have been carried out to identify a systemic pharmacologic treatment able to accelerate venous ulcer healing times, but frequently the results have not been satisfactory. The aim of this study was to evaluate the efficacy of sulodexide, a drug with profibrinolytic and antithrombotic activity, in accelerating venous ulcer's healing time. Ninety-four patients (32 men and 62 women), aged 72 years old on average, were randomly distributed between two groups. In the first group ("control group") a standard treatment was applied, which consisted of cleansing by washing with physiological solution and the application of elastic compression with short-extensibility, removable bandages. The second group ("sulodexide group") received the standard treatment plus sulodexide (600 lipoprotein lipase releasing units [LRU] by im route per day for 30 consecutive days, followed by 500 LRU by oral route per day for a further 30 days). After 2 months the venous ulcers were found healed in 15 patients (36%) in the control group and in 30 patients (58%) in the sulodexide group (p = 0.03). The life table showed that the healing times were shorter in the sulodexide group in the first 2 months of treatment. Total healing times amounted to 110 days in the control group and 72 days in the sulodexide group (p = 0.08) and the results were in proportion to the initial severity of the lesion. A significant correlation was noted between ulcer healing times and severity of the initial ulcerous lesion, the duration of the ulcer, and the group the patient belonged to. No correlation was found between age, gender of the patient and the etiology of the ulcer. In conclusion sulodexide was shown effective in the treatment of venous leg ulcers, yielding healing more quickly than the standard treatment.

Treatment of Venous Leg Ulcers with Sulodexide

The aim was to look at the effect of sulodexide in diabetic and non-diabetic patients with peripheral occlusive arterial disease (POAD), by verifying, through meta-analysis of Italian data, if the drug affects the clinical course of claudication or the main risk factors for POAD. Sulodexide increases the pain-free walking distance (benefit 36% vs controls, P 1). There was a marked effect in lowering triglycerides (overall -28%, P = 0.0015), fibrinogen (-13%, P < 0.0001) and plasma and serum viscosities, and in increasing high-density-lipoprotein cholesterol (24.4%, P = 0.0007). The medium-term administration of sulodexide has a therapeutic effect on claudication of diabetic and/or hyperlipidaemic patients suffering from POAD stages- and also counteracts several POAD risk factors. Long-term use of sulodexide appears to be well tolerated. The treatment has a low daily cost; therefore, it has a favourable cost-benefit ratio, in view of the high general costs associated with global POAD care, particularly in diabetic patients.

Meta-analysis of some results of clinical trials on sulodexide therapy in peripheral occlusive arterial disease.

In patients affected with peripheral obliterative arterial disease, the intravenous infusion of 50 mg buflomedil prevented ischaemia-dependent impairment of whole blood viscosity (WBV) and filterability (WBF) in the course of isotonic ischaemic exercise of an upper limb. The drug was also able to reduce the effects of ischaemia on some functional parameters of polymorphonuclear leukocytes (PMNs), such as superoxide anion generation induced by the formylated oligopeptide fMLP, and cytosolic free calcium level modifications in resting and fMLP-stimulated cells. An enhancement of ischaemia-dependent increase in adenosine plasma levels was also observed as associated with the effects of buflomedil. Treatment with the adenosine receptor antagonist theophylline was able to partially remove the effects of buflomedil. Thus, the possibility is suggested that some pharmacological properties of buflomedil could depend, at least in part, on an interference with the adenosine system.

Buflomedil prevents ischaemia-dependent changes in blood rheology and neutrophil reactivity. A possible adenosine-mediated mechanism

Effect of adenosine I.V. infusion on peripheral haemodynamics, haemorheology and platelet behaviour in man

Many vascular pathologies have been reported to follow a diurnal rhythm (AMI, angina, stroke, sudden cardiac death, pulmonary thromboembolism) with a peak in the early morning. Aim of the study was to evaluate the existence of a diurnal rhythm of platelet aggregability and blood rheology. The study was carried out in 12 subjects; blood withdrawings were performed every 3 hour for 24 hours and in each blood sample platelet aggregation (on PRP and on washed platelets) and haemorheological parameters (blood viscosity, blood filterability, haematocrit and fibrinogen) were measured. Moreover systolic and diastolic blood pressure was recorded by dynamiC monitoring. The results show that a circadian rhythm of the above mentioned parameters does exists. Even if our data do not prove a strict correlation between these parameters and the incidence of the vascular pathology, it could be interesting to keep in mind the existence of a temporal parallelism when starting preventive therapy.

Circadian variation of platelet aggregation and blood rheology

Rheological changes associated with neutrophil priming and activation during provoked ischaemia in man

Hemodynamic, hemorheologic and neurohumoral modifications induced by i.v. infusion of adenosine in man

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