Effect of danaparoid sodium on proteinuria, von Willebrand factor, and hard exudates in patients with diabetes mellitus type 2

In diabetic nephropathy, heparan sulfate glycosaminoglycan side chains are reduced in glomerular basement membranes proportionally to the degree of pr oteinuria. Recently, it was demonstrated that additional therapy with danap aroid sodium, a mixture of sulfated glycosaminoglycans with mainly heparan sulfate, lowered proteinuria in type 1 diabetes patients with diabetic neph ropathy. A randomized placebo-controlled parallel study was performed with 750 anti-Xa units of danaparoid sodium once daily in type 2 diabetes patien ts with severe proteinuria. The aim of the study was to evaluate the possib le effects of danaparoid sodium on proteinuria, endothelial dysfunction, an d hard exudates in the retina and to determine the safety/tolerability of t his drug. Twenty-two patients completed the study, and one patient had to s top prematurely after 6 wk of danaparoid sodium treatment be-cause of urtic aria at the injection sites. Apart from a small decrease of hemoglobin and minor skin hematomas at the injection site in five patients in the danaparo id sodium group, no other safety parameters showed any clinically or statis tically significant difference between and within groups. The relative chan ge in time of both the urinary albumin and protein excretion rate corrected for creatinine did not differ between both treatment arms (P = 0.2 and 0.4 9, respectively). No retinal complications or changes of hard exudates occu rred. von Willebrand factor was elevated in both groups, but was not influe nced by either treatment modality. Contrary to the beneficial effects that occurred in type I diabetes patients with diabetic nephropathy, treatment f or 8 wk with 750 anti-Xa units of danaparoid sodium gave no reduction of pr oteinuria, hard exudates, and von Willebrand factor.