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

European Heart Journal

Volumn 23, Issue 13, 2002, Pages 1057-1065

  Coccheri, Sergio ^a   Scondotto, G ^b   Agnelli, G ^c   Palazzini, E ^d   Zamboni, V ^d  

^a UNIVERSITY OF BOLOGNA   (Italy)

^b Day Hospital 'Mengoli' Bologna   (Italy)

^c UNIVERSITY OF PERUGIA   (Italy)

^d Medical Department   (Italy)

Author keywords

Claudication; Fibrinogen; Peripheral artery disease; Sulodexide

Indexed keywords

DERMATAN SULFATE; FIBRINOGEN; GLYCOSAMINOGLYCAN; HEPARIN DERIVATIVE; PLACEBO; SULODEXIDE; VESSEL DUE F;

ADULT; AGED; ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG FATALITY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EPIGASTRIC PAIN; ERYTHEMA; FAINTNESS; FEMALE; FIBRINOGEN BLOOD LEVEL; HEMATOMA; HUMAN; IMPOTENCE; INJECTION PAIN; INJECTION SITE; INTERMITTENT CLAUDICATION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PAIN; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; VEIN THROMBOSIS; VERTIGO; WALKING;

AGED; ANALYSIS OF VARIANCE; DOUBLE-BLIND METHOD; FEMALE; FIBRINOGEN; FIBRINOLYTIC AGENTS; GLYCOSAMINOGLYCANS; HUMANS; INTERMITTENT CLAUDICATION; ITALY; MALE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 0036660264     PISSN: 0195668X     EISSN: None     Source Type: Journal    
DOI: 10.1053/euhj.2001.3033     Document Type: Article

References (39)

1. Kannel WB. The demographics of claudication and the ageing of the American population. Vasc Med 1996; 1: 60-4.
2. Criqui MH, Coughlin SS, Fronek A. Noninvasively diagnosed peripheral arterial disease as a predictor of mortality: results from a prospective study. Circulation 1985; 72: 768-73.
3. Fowkes FG, Housley E, Cawood EH, Macintyre CC, Ruckley CV, Prescott RJ. Edinburgh Artery Study: prevalence of asymptomatic and symptomatic peripheral arterial disease in the general population. Int J Epidemiol 1991; 20: 384-92.
4. Dormandy J, Mahir M, Ascady G et al. Fate of the patient with chronic leg ischaemia. A review article. J Cardiovasc Surg 1989; 30: 1925-31.
5. Aronow WS, Ahn C. Prevalence of coexistence of coronary artery disease, peripheral arterial disease, and atherothrombotic brain infarction in men and women ≥62 years of age. Am J Cardiol 1994; 74: 64-5.
6. Zheng ZJ, Sharrett AR, Chambless LE et al. Associations of ankle-brachial index with clinical coronary heart disease, stroke and preclinical carotid and popliteal atherosclerosis: the Atherosclerosis Risk in Communities (ARIC) study. Atherosclerosis 1997; 131: 115-25.
7. Criqui MH, Denenberg JO, Langer RD, Fronek A. The epidemiology of peripheral arterial disease: importance of identifying the population at risk. Vasc Med 1997; 2: 221-6.
8. Leng GC, Fowkes FG, Lee AJ, Dunbar J, Housley E, Ruckley CV. Use of ankle brachial pressure index to predict cardiovascular events and death: a cohort study. Br Med J 1996; 313: 1440-4.
9. Coccheri S, Palareti G, Fortunato G. Antithrombotic drugs in peripheral obliterative arterial diseases. Haemostasis 1994; 24: 118-27.
10. Janzon L, Bergqvist D, Boberg J et al. Prevention of myocardial infarction and stroke in patients with intermittent claudication; effects of ticlopidine. Results from STIMS, the Swedish Ticlopidine Multicentre Study. J Intern Med 1990; 227: 301-8.
11. CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet 1996; 16 (348): 1329-39.
12. Collaborative overview of randomised trials of antiplatelet therapy I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Antiplatelet Trialists' Collaboration. BMJ 1994; 308: 81-106.
13. Collaborative overview of randomised trials of antiplatelet therapy II. Maintenance of vascular graft or arterial patency by antiplatelet therapy. Antiplatelet Trialists' Collaboration. BMJ 1994; 308: 159-68.
14. Girolami B, Bernardi E, Prins MH et al. Antithrombotic drugs in the primary medical management of intermittent claudication: a meta-analysis. Thromb Haemost 1999; 81: 715-22.
15. Hood SC, Moher D, Barber GG. Management of intermittent claudication with pentoxifylline: meta-analysis of randomized controlled trials. CMAJ 1996; 155: 1053-9.
16. Reilly MP, Mohler ER. Cilostazol: treatment of intermittent claudication. Ann Pharmacother 2001; 35: 48-56.
17. Dawson DL, Cutler BS, Hiatt WR et al. A comparison of cilostazol and pentoxifylline for treating intermittent claudication. Am J Med 2000; 109: 523-30.
18. Violi F, Marubini E, Coccheri S, Nenci GG. Improvement of walking distance by defibrotide in patients with intermittent claudication - results of a randomized, placebo-controlled study (the DICLIS study). Thromb Haemost 2000; 83: 672-7.
19. Brevetti G, Diehm C, Lambert D. European multicenter study on propionyl-L-carnitine in intermittent claudication. J Am Coll Cardiol 1999; 34: 1618-24.
20. Balsano F, Coccheri S, Libretti A et al. Ticlopidine in the treatment of intermittent claudication: a 21-month double-blind trial. J Lab Clin Med 1989; 114: 84-91.
21. Palareti G, Poggi M, Torricelli P, Balestra V, Coccheri S. Long-term effects of ticlopidine on fibrinogen and haemorheology in patients with peripheral arterial disease. Thromb Res 1988; 52: 621-9.
22. Andreozzi GM, Signorelli S, Cacciaguerra G et al. Three-month therapy with calcium-heparin in comparison with ticlopidine in patients with peripheral arterial occlusive disease at Leriche-Fontaine IIb class. Angiology 1993; 44: 307-13.
23. Allegra C, Pollari G, Carioti B, Sardina M. Thrombin and platelet inhibition with low dose calcium heparin in comparison with ASA in patients with peripheral arterial disease at Leriche-Fontaine IIb class. Int J Clin Pharmacol 1994; 12: 646-51.
24. Palmieri G, Ambrosi G, Agrati AM, Ferraro G, Marcozzi S. A new low molecular weight heparin in the treatment of peripheral arterial disease. Int Angiol 1988; 7 (3 Suppl): 41-7.
25. Mannarino E, Pasqualini L, Innocente S et al. Efficacy of low-molecular-weight heparin in the management of intermittent claudication. Angiology 1991; 42: 1-7.
26. Calabro A, Piarulli F, Milan D, Rossi A, Coscetti G, Crepaldi G. Clinical assessment of low molecular weight heparin effects in peripheral vascular disease. Angiology 1993; 44: 188-95.
27. Frampton JE, Faulds D. Parnaparin. A review of its pharmacology, and clinical application in the prevention and treatment of thromboembolic and other vascular disorders. Drugs 1994; 47: 652-76.
28. Ofosu FA. Pharmacological actions of sulodexide. Semin Thromb Hemost 1998; 24: 127-38.
29. Harenberg J. Review of pharmacodynamics, pharmacokinetics, and therapeutic properties of sulodexide. Med Res Rev 1998; 18: 1-20.
30. Messa GL, La Placa G, Puccetti L et al. Pharmacodynamic effects of sulodexide on profibrinolytic and haemorrheological patterns. Clin Drug Invest 1995; 10: 165-71.
31. Agrati AM, Mauro M, Savasta C. A double-blind, cross-over, placebo-controlled study of the profibrinolytic and antithrombotic effects of oral sulodexide. Adv Ther 1992; 9: 147-55.
32. Mannarino E, Pasqualini L, Ciuffetti G. Effect of oral administration of sulodexide on fibrinolysis and plasma viscosity: a pilot study. Drug Invest 1992; 346-50.
33. Mauro M, Ferraro G, Palmieri G. Profibrinolytic and antithrombotic effects of sulodexide oral administration: a double-blind, cross-over, placebo-controlled study. Curr Ther Res 1992; 51: 342-50.
34. 131I-labelled fast-moving heparin after single intravenous and oral administration on man at different doses. Br J Clin Res 1992; 3: 161-78.
35. Fiore G, Baraldi A, Gambarotta C et al. Inhibition of plasminogen activator inhibitor (PAI-1) by sulodexide in post-thrombophlebitic patients. J Drug Devel 1991; 3: 173-8.
36. Ceriello A, Quatraro A, Ettorre M, Marchi E, Barbanti M, Giugliano D. Glucosaminoglycans administration decreases high fibrinogen plasma levels in diabetic patients. Diab Nutr Metab 1993; 6: 14.
37. Cospite M, Ferrara F, Cospite V, Palazzini E. Sulodexide and the microcirculatory component in microphlebopathies. Curr Med Res Opin 1992; 13: 56-60.
38. Gaddi A, Galetti C, Illuminati B, Nascetti S. Meta-analysis of some results of clinical trials on sulodexide therapy in Peripheral Occlusive Arterial Disease. J Intl Med Res 1996; 24: 389-406.
39. Condorelli M, Chiariello M, Dagianti A et al. IPO-V2: a prospective, multicenter, randomized, comparative clinical investigation of the effects of sulodexide in preventing cardiovascular accidents in the first year after acute myocardial infarction. J Am Coll Cardiol 1994; 23: 27-34.