A Clinical Experience on Sulodexide in the Treatment of Patients with Diabetic Nephropathy

Background: Diabetic nephropathy, characterized by albuminuria, is a severe complication of diabetes mellitus, leading cause of end-stage renal disease. The aim of the present study was to evaluate the efficacy and safety of sulodexide, alone or in combination with captopril, versus captopril alone in consecutive adult patients with diabetic nephropathy. Methods: Patients aged ≥ 18 years, with type 1 or type 2 diabetes mellitus and albumin excretion rate (AER) ≥ 30 mg/24 h, without severe renal insufficiency, cardiac or hepatic insufficiency, or haematuria, were enrolled. Patients were treated with captopril 25 mg twice daily, sulodexide 25 mg twice daily, or a combination of captopril 25 mg twice daily + sulodexide 25 mg twice daily for 6 months. The primary endpoint was the evaluation of AER. Secondary endpoints included evaluation of arterial blood pressure, fasting glucose, HbA1c, serum creatinine and uricemia and safety. Results: Globally, 123 patients were enrolled and treated with captopril alone (n=42), sulodexide alone (n=53) or sulodexide plus captopril (n=28). After adjustment for initial albuminuria, the AER reduction at T3 and T6 versus T0, although highly significant in all treatment groups, was higher in patients treated with the combination or with sulodexide alone than in patients given captopril alone (further decrease of 17.6% and 18.2% at T3 and of 29.3% and 19.8% at T6, respectively). In the whole population, serum creatinine and uric acid levels increased during the study, HbA1c and fasting glucose levels increased from T0 to T3 and remained stable thereafter, while blood pressure was constant throughout the study. Sulodexide was well tolerated. Conclusions: Long term administration of sulodexide 50 mg/day, both in monotherapy or in combination with captopril, is effective and well tolerated in reducing proteinuria in diabetic patients and can be considered a valid therapeutical option in order to prevent major complications and reduce morbidity and mortality in this population.