A RANDOMIZED, CONTROLLED-STUDY OF SULODEXIDE THERAPY FOR THE TREATMENT OF DIABETIC NEPHROPATHY

Background. Glycosaminoglycans (GAGs) play an important role in the ph ysiopathology of diabetic nephropathy; they are essential for the main tenance of glomerular charge selectivity and their administration can reduce albuminuria in diabetic patients. Methods. Following a randomiz ed block design, controlled versus placebo, we investigated, in insuli n-dependent diabetic patients with micro- or macroalbuminuria, whether GAG therapy can influence an altered albumin excretion rate (AER). Th irty-six patients (18 micro- and 18 macroalbuminuric) were randomized to receive, during 5 days/week for 3 weeks either a daily dose of 600 lipoproteinlipase releasing units (LRU) of sulodexide by the i.m. rout e (9 micro- and 9 macroalbuminuric patients), or a matching i.m. place bo (9 micro-and 9 macroalbuminuric patients). All patients were follow ed-up for further 6 weeks. AER was evaluated before treatment, weekly during it and every 3 weeks during follow-up. Results. Seventeen of th e 18 sulodexide-treated patients showed a trend towards decrease in AE R, more evident and statistically significant in microalbuminurics (P < 0.01 after the first week). At the end of follow-up, AER was still s ignificantly reduced in microalbuminurics, while macroalbuminurics sho wed again increased values. Placebo-treated patients evidenced no AER variations during all the study period. No statistically significant d ifferences vs baseline, concerning blood pressure, haematological, hae matochemical, and coagulative tests, and urinalysis, were ever observe d, apart from a clear-cut decrease in blood cholesterol and triglyceri des at the end of treatment, in a subgroup of hyperlipidaemic, sulodex ide-treated subjects. No adverse events were registered.Conclusions. O ur results suggest that the GAG sulodexide exerts a positive activity in type I diabetic patients with micro-and macroalbuminuria, by reduci ng the abnormally high AER levels.