One year course of oral sulodexide in the management of diabetic nephropathy

Journal of Nephrology

Volumn 18, Issue 5, 2005, Pages 568-574

  Achour, Abdellatif ^a   Kacem, Maha ^a   Dibej, Kamel ^a   Skhiri, Habib ^a   Bouraoui, Samia ^a   El May, Mezri ^a  

^a Nephrology and Internal Medicine Service EPS F Bourguiba   (Tunisia)

Author keywords

AER; Albuminuria; Diabetes mellitus; Glycosaminoglycan; Nephropathy; Oral administration; Sulodexide; TGF beta; Vascular complication

Indexed keywords

SULODEXIDE; VESSEL DUE F;

ADULT; ARTICLE; CHEMICAL PARAMETERS; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETIC NEPHROPATHY; DISEASE COURSE; DRUG DOSE REGIMEN; DRUG TOLERABILITY; FEMALE; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; MALE; METABOLIC PARAMETERS; MICROALBUMINURIA; NON INSULIN DEPENDENT DIABETES MELLITUS; PROTEINURIA; SIDE EFFECT;

ADMINISTRATION, ORAL; ADULT; ALBUMINURIA; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; DIABETIC NEPHROPATHIES; FEMALE; GLYCOSAMINOGLYCANS; HUMANS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES;

EID: 29244469623     PISSN: 11218428     EISSN: 17246059     Source Type: Journal    
DOI: None     Document Type: Article

References (37)

1. Nathan DM. Long-term complications of diabetes mellitus. N Engl J Med 1993; 328: 1676-85.
2. Borch-Johnsen K, Andersen PK, Deckert T. The effect of proteinuria on relative mortality in type 1 (insulin-dependent) diabetes mellitus. Diabetologia 1985; 28: 590-6.
3. Nelson RG, Pettitt DJ, Carraher MJ, Baird HR, Knowler WC. Effect of proteinuria on mortality in NIDDM. Diabetes 1988; 37: 1499-504.
4. Kaiser N, Sasson S, Feener EP, Boukobza-Vardi N, Higashi S, Moller DE, Davidheiser S, Przybylski RJ, King GL. Differential regulation of glucose transport and transporters by glucose in vascular endothelial and smooth muscle cells. Diabetes 1993; 42: 80-9.
5. Nishikawa T, Edelstein D, Du XL, Yamagishi S, Matsumura T, Kaneda Y, Yorek MA, Beebe D, Oates PJ, Hammes HP, Giardino I, Brownlee M. Normalizing mitochondrial superoxide production blocks three pathways of hyperglycaemic damage. Nature 2000; 404: 787-90.
6. Remuzzi G, Schieppati A, Ruggenenti P. Clinical practice. Nephropathy in patients with type 2 diabetes. N Engl J Med 2002; 346: 1145-51.
7. Nosadini R, Velussi M, Brocco E, Abaterusso C, Piarulli F, Morgia G, Satta A, Faedda R, Abhyankar A, Luthman H, Tonolo G. Altered transcapillary escape of albumin and microalbuminuria reflects two different pathogenic mechanisms. Diabetes 2005; 54: 228-33.
8. Benigni A, Gagliardini E, Tomasoni S, Abbate M, Ruggenenti P, Kalluri R, Remuzzi G. Selective impairment of gene expression and assembly of nephrin in human diabetic nephropathy. Kidney Int 2004; 65: 2193-200.
9. Ceol M, Gambaro G, Sauer U, Baggio B, Anglani F, Forino M, Facchin S, Bordin L, Weigert C, Nerlich A, Schleicher ED. Glycosaminoglycan therapy prevents TGF-beta1 overexpression and pathologic changes in renal tissue of long-term diabetic rats. J Am Soc Nephrol 2000; 11: 2324-36.
10. Gambaro G, Venturini AP, Noonan DM, Fries W, Re G, Garbisa S, Milanesi C, Pesarini A, Borsatti A, Marchi E, et al. Treatment with a glycosaminoglycan formulation ameliorates experimental diabetic nephropathy. Kidney Int 1994; 46: 797-806.
11. Chakrabarti S, Ma N, Sima AA. Reduced number of anionic sites is associated with glomerular basement membrane thickening in the diabetic BB-rat. Diabetologia 1989; 32: 826-8.
12. Tamsma JT, van den Born J, Bruijn JA, Assmann KJ, Weening JJ, Berden JH, Wieslander J, Schrama E, Hermans J, Veerkamp JH, et al. Expression of glomerular extracellular matrix components in human diabetic nephropathy: decrease of heparan sulphate in the glomerular basement membrane. Diabetologia 1994; 37: 313-20.
13. van den Born J, van den Heuvel LP, Bakker MA, Veerkamp JH, Assmann KJ, Berden JH. A monoclonal antibody against GBM heparan sulfate induces an acute selective proteinuria in rats. Kidney Int 1992; 41: 115-23.
14. Rosenzweig LJ, Kanwar YS. Removal of sulfated (heparan sulfate) or non sulfated (hyaluronic acid) glycosaminoglycans results in increased permeability of the glomerular basement membrane to 125I-bovine serum albumin. Lab Invest 1982; 47: 177-84.
15. Kahaly G, Hansen C, Otto E, Forster G, Beyer J, Hommel G. Diabetic microangiopathy and urinary glycosaminoglycans. Exp Clin Endocrinol Diabetes 1997; 105: 145-51.
16. Gambaro G, Cicerello E, Mastrosimone S, Lavagnini T, Baggio B. High urinary excretion of glycosaminoglycans: a possible marker of glomerular involvement in diabetes. Metabolism 1989; 38: 419-20.
17. Myrup B, Hansen PM, Jensen T, Kofoed-Enevoldsen A, Feldt-Rasmussen B, Gram J, Kluft C, Jespersen J, Deckert T. Effect of low-dose heparin on urinary albumin excretion in insulin-dependent diabetes mellitus. Lancet 1995; 345: 421-2.
18. Tamsma JT, van der Woude FJ, Lemkes HH. Effect of sulphated glycosaminoglycans on albuminuria in patients with overt diabetic (type 1) nephropathy. Nephrol Dial Transplant 1996; 11: 182-5.
19. van der Pijl JW, van der Woude FJ, Geelhoed-Duijvestijn PH, Frolich M, van der Meer FJ, Lemkes HH, van Es LA. Danaparoid sodium lowers proteinuria in diabetic nephropathy. J Am Soc Nephrol 1997; 8: 456-62.
20. Nielsen S, Schmitz A, Bacher T, Rehling M, Ingerslev J, Mogensen CE. Transcapillary escape rate and albuminuria in Type II diabetes. Effects of short-term treatment with low-molecular weight heparin. Diabetologia 1999; 42: 60-7.
21. Solini A, Carraro A, Barzon I, Crepaldi G. Therapy with glycosaminoglycans lower albumin excretion rate in non-insulin dependent diabetic patients with microalbuminuria. Diabetes, nutrition & metabolism 1994; 7: 304-7.
22. Dedov I, Shestakova M, Vorontzov A, Palazzini E. A randomized, controlled study of sulodexide therapy for the treatment of diabetic nephropathy. Nephrol Dial Transplant 1997; 12: 2295-300.
23. Poplawska A, Szelachowska M, Topolska J, Wysocka-Solowie B, Kinalska I. Effect of glycosaminoglycans on urinary albumin excretion in insulin-dependent diabetic patients with micro- or macroalbuminuria. Diabetes Res Clin Pract 1997; 38: 109-14.
24. Solini A, Vergnani L, Ricci F, Crepaldi G. Glycosaminoglycans delay the progression of nephropathy in NIDDM. Diabetes Care 1997; 20: 819-23.
25. Sorrenti G, Grimaldi M, Canova N, Palazzini E, Melchionda N. Glycosaminoglycans as a possible tool for micro- and macroalbuminuria in diabetic patients. A pilot study. J Int Med Res 1997; 25: 81-6.
26. Szelachowska M, Poplawska A, Topolska J, Kinalska I, Grimaldi M. A pilot study of the effect of the glycosaminoglycan sulodexide on microalbuminuria in type I diabetic patients. Curr Med Res Opin 1997; 13: 539-45.
27. Velussi M, Monte AD, Cernigoi AM, Dapas F. Glycosaminoglycans oral therapy reduces microalbuminuria, blood fibrinogen levels and limb arteriopathy clinical signs in patients with non-insulin dependent diabetes mellitus. Diabetes Nutr Metab 1996; 9: 53-8.
28. Gambaro G, Kinalska I, Oksa A, Pont'uch P, Hertlova M, Olsovsky J, Manitius J, Fedele D, Czekalski S, Perusicova J, Skrha J, Taton J, Grzeszczak W, Crepaldi G. Oral sulodexide reduces albuminuria in microalbuminuric and macroalbuminuric type 1 and type 2 diabetic patients: the Di.N.A.S. randomized trial. J Am Soc Nephrol 2002; 13: 1615-25.
29. Parving HH, Chaturvedi N, Viberti G, Mogensen CE. Does microalbuminuria predict diabetic nephropathy? Diabetes Care 2002; 25: 406-7.
30. Isomaa B, Almgren P, Tuomi T, Forsen B, Lahti K, Nissen M, Taskinen MR, Groop L. Cardiovascular morbidity and mortality associated with the metabolic syndrome. Diabetes Care 2001; 24: 683-9.
31. Weigert C, Brodbeck K, Haring HU, Gambaro G, Schleicher ED. Low-molecular-weight heparin prevents high glucose- and phorbol ester-induced TGF-beta 1 gene activation. Kidney Int 2001; 60: 935-43.
32. Coccheri S, Scondotto G, Agnelli G, Palazzini E, Zamboni V. Sulodexide in the treatment of intermittent claudication. Results of a randomized, double-blind, multicentre, placebo-controlled study. Eur Heart J 2002; 23: 1057-65.
33. Coccheri S, Scondotto G, Agnelli G, Aloisi D, Palazzini E, Zamboni V. Randomised, double blind, multicentre, placebo controlled study of sulodexide in the treatment of venous leg ulcers. Thromb Haemost 2002; 87: 947-52.
34. Hogan P, Dall T, Nikolov P. Economic costs of diabetes in the US in 2002. Diabetes Care 2003; 26: 917-32.
35. ERA/EDTA registry. Annual Report 2003, http://www.era-edtareg.org/files/annualreports/pdf/AnnRep2003.pdf.
36. Hostetter TH. Prevention of end-stage renal disease due to type 2 diabetes. N Engl J Med 2001; 345: 910-2.
37. Keryx Biopharmaceuticals. Keryx announces positive interim results from phase 2 clinical study for KRX-101 (sulodexide gelcaps) for the treatment of diabetic nephropathy. http://www.keryx.com May 2005; 5.