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

Background: Diabetic nephropathy is a multifactorial diabetic complication whose long-term consequences involve chronic renal insufficiency and increased rate of cardiovascular death. Besides oxidative stress, and hemodynamic changes, glycosaminoglycans (GAGs) are an additional component implicated in the onset of glomerular abnormalities. GAG replacement therapy was envisaged in the nineties for the treatment of diabetic nephropathy and sulodexide is the most extensively investigated GAG to reduce albuminuria in diabetic patients.

Methods: In this study we have evaluated the effect of a long-term course of oral sulodexide at a moderate dosage in the treatment of patients affected by diabetic nephropathy. Thirty patients with type 1 and 2 diabetes mellitus (DM) have been treated with 50 mg/ daily oral sulodexide for 12 months while thirty matched diabetic patients constituted the control group. All the patients attended monthly visits and controls of biochemical and metabolic parameters.

Results: At 12 months albuminuria was greatly reduced in patients treated with sulodexide and increased in the control group (260% and +29% vs baseline, respectively; p = 0.0001). The drug appeared active in both type 1 and type 2 diabetes and in both micro- and macroalbuminuric patients. No change in metabolic control and no systemic side effects were reported.

Conclusions: In our diabetic patients sulodexide therapy has been proven to greatly reduce albuminuria, and to have the potential to delay progression from incipient to overt nephropathy.