Improvement of walking distance by defibrotide in patients with intermittent claudication. Results of a randomized, placebo-controlled study (the DICLIS study)

Thrombosis and Haemostasis

Volumn 83, Issue 5, 2000, Pages 672-677

  Violi, F ^a   Marubini, E ^b   Coccheri, S ^b   Nenci, G G ^b  

^a POLICLINICO UMBERTO I   (Italy)

^b NONE

Author keywords

Fibrinolytic agents; Intermittent claudication; Polydeoxyribonucleotides

Indexed keywords

ANTICOAGULANT AGENT; DEFIBROTIDE; PLACEBO; PROSTACYCLIN;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; FIBRINOLYSIS; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HEADACHE; HUMAN; INTERMITTENT CLAUDICATION; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREADMILL; WALKING;

EID: 0034018994     PISSN: 03406245     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0037-1613890     Document Type: Article

References (24)

1. Coffman JD. Intermittent claudication: Be conservative. N Engl J Med 1991; 325: 577-8.
2. Criqui MH, Langer RD. Fronek A, Feigelson HS, Klauher MR, McCann TJ, Browner D. Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med 1992; 326: 381-6.
3. Weitz JI, Byrne J, Clagett P, Farkouh ME, Porter JM, Sackett DL, Strandness E, Taylor LM. Diagnosis and Treatment of Chronic Arterial Insufficiency of the Lower Extremities: A Critical Review. Circulation 1996; 94: 3026-49.
4. Berti F, Rossoni G, Niada R, Omini C, Pretolani M. Mandelli C. Beneficial Effects of Defibrotide against Myocardial Ischemia and Decline of B-Adrenoceptor Function in the Rabbit. Haemostasis 1986; 16 (Suppl 1): 13-7.
5. Niada R, Mantovani M, Prino G, Pescador R, Berti F, Omini C, Folco GC. Antithrombotic activity of a polydeoxyribonucleotidic substance extracted from mammalian organs: a possible link with prostacyclin. Thromb Res 1981; 23: 233-46.
6. 2 but not of platelet thromboxane formation by defibrotide in the platelet perfused heart. Naunyn Schmiedebergs Arch Pharmacol 1985; 331: 125-30.
7. Coccheri S, Biagi G, Legnani C. Bianchini B, Grauso F. Acute effects of Defibrotide, an experimental antithrombotic agent, on fibrinolysis and blood prostanoids in man. A placebo controlled study. Eur J Clin Pharmacol 1988; 35: 151-6.
8. Biagi G, Legnani C, Rodorigo G, Coccheri S. Modulation of arachidonate metabolite generation in human blood by oral defibrotide. Arzneimittelforschung 1991; 41: 511-5.
9. Costantini V, Luzi P, Boselli C, Bastiano ML, Bisacci R. Nenci GG. Effects of defibrotide on prostanoid synthesis and fibrinolytic activity in human veins. Eur J Intern Med 1989; 1: 115-20.
10. Mussoni L. Evolvi C, Donati MB. Activation of plasma and vascular fibrinolytic activity by a polydeoxyribonucleotidic substance, fraction P, in rats and rabbits. Thromb Haemost 1979; 42: 388.
11. Violi F, Ferro D. Alessandri C, Quintarelli C, Saliola M, Balsano F. Inhibition of tissue plasminogen activator inhibitor by defibrotide in atherosclerotic patients. Semin Thromb Hemost 1989; 15: 226-9.
12. Violi F, Ferro D, Saliola M, Quintarelli C, Basili S, Balsano F. Effect of oral defibrotide on tissue-plasminogen activator inhibitor balance. Eur J Clin Pharmacol 1992; 42: 379-83.
13. Richardson PG, Elias AD. Krishnan A, Wheeler C, Nath R, Hoppensteadt D, Kinchla NM, Neuberg D, Waller EK, Antin JH, Soiffer R, Vredenburgh J, Lill M, Woolfrey AE, Bearman SI. Iacobelli M, Fareed J, Guinan EC. Treatment of Severe Veno-Occlusive Disease With Defibrotide: Compassionate Use Results in Response Without Significant Toxicity in a High-Risk Population. Blood 1998; 92: 737-44.
14. Strano A, Fareed J, SabbàC, Albano O, Allegra C, Carlizza A, Binaghi F, Fronteddu F, Del Guercio R. Arpaia MR. Pinto A. Alletto G, Walenga JM, Hoppensteadt D, Nazzari M. Ferrari PA. A double-blind, multicenter, placebo controlled, dose comparison study of orally administered defibrotide: preliminary results in patients with peripheral arterial disease. Semin Thromb Hemost 1991; 17 (Suppl. 2): 228-34.
15. Fleiss JL. The parallel Group Design. In: Fleiss JL, editors. The design and analysis of clinical experiments. New York: John Wiley and Sons 1986: 46-51.
16. Diggle PJ. Liang KY. Zeger SL. editors. The analysis of longitudinal data. Oxford University Press, 1994.
17. Walter SD, Feinstein AR, Wells CK. Coding ordinal independent variables in multiple regression analyses. Am J Epidemiol 1987; 125: 319-23.
18. SAS Institute. SAS's user guidelines: basic version 5th edition. Cary NC: SAS Institute 1985.
19. Bagger JP, Helligsoe P, Randsbaek F, Kimose HH, Jensen BS. Effect of Verapamil in Intermittent Claudication. A Randomized, Double-Blind. Placebo-Controlled, Cross-over Study after Individual Dose-Response Assessment. Circulation 1997; 95: 411-5.
20. Brevetti G, Chiariello M, Ferulano G, Policicchio A, Nevola E, Rossini A. Attisano T, Ambrosio G, Siliprandi N, Angelini C. Increases in walking distance in patients with peripheral vascular disease treated with L-carnitine: a double-blind, cross-over study. Circulation 1988; 77: 767-73.
21. Hess H, Mietaschk A. Deichsel G. Drug-induced inhibition of platelet function delays progression of peripheral occlusive arterial disease: A prospective double-blind arteriographically controlled trial. Lancet 1985; 1: 415-9.
22. Goldhaber SZ, Manson JE, Stampfer MJ, LaMotte F. Rosner B, Buring JE Hennekens CH. Low-dose aspirin and subsequent peripheral arterial surgery in the Physicians' Health Study. Lancet 1992; 340: 153-5.
23. Balsano F, Coccheri S, Libretti A, Nenci GG, Catalano M, Fortunato G, Grasselli S, Violi F, Hellemans H, Vanhove P. Ticlopidine in the treatment of intermittent claudication: a 21 -months double-blind trial. J Lab Clin Med 1989; 115: 84-91.
24. Smith FB, Rumley A, Lee AJ, Leng GC, Fowkes FGR, Lowe GDO. Haemostatic factors and prediction of ischaemic heart disease and stroke in claudicants. Br J Haematol 1998; 100: 758-63.