Efficacy of low-dose oral sulodexide in the management of diabetic nephropathy.

Abstract

BACKGROUND:

Diabetic nephropathy (DN) is the single greatest cause of end-stage renal disease (ESRD). Without specific interventions, microalbuminuria (incipient nephropathy) gradually progresses to macroalbuminuria (overt nephropathy) within 10-15 years in about 80% of type 1 and 30% of type 2 diabetic patients, and to ESRD within further 20 years in about 75% and 20%, respectively. A primary alteration in DN consists of decreased concentration of glycosaminoglycans (GAGs) in the glomerular extracellular matrix. This evidence has prompted interest in using exogenous GAGs and specifically sulodexide in DN treatment.

PATIENTS AND METHODS:

In this uncontrolled multicenter study, diabetic patients with albumin excretion rate (AER) >or=30 mg/24 hours were treated with oral sulodexide 50 mg/day for 6 months, while receiving concomitant medication as required. Two hundred thirty-seven patients (54% males and 46% females, mean age 55 years, mean diabetes duration 11 years) were evaluated; 89% had type 2 and 11% type 1 diabetes mellitus, 67% microalbuminuria and 33% macroalbuminuria.

RESULTS:

AER was significantly and progressively reduced during sulodexide treatment (p<0.0001): geometric mean after 3 and 6 months was 63.7% (95% confidence interval [95% CI], 59.3%-68.4%) and 42.7% (95% CI, 37.8%-48.2%) of baseline, respectively. The reduction was similar in type 1 and type 2 diabetes and was slightly greater in macroalbuminuric than in microalbuminuric patients. Blood pressure was slightly lowered, while fasting glucose and glycosylated hemoglobin were moderately reduced. Adverse effects were observed in 5.5% of patients, including gastrointestinal in 3.8%.

CONCLUSIONS:

Sulodexide therapy was shown to reduce AER in patients with DN.

• Authors: Samira Blouza, Sabeur Dakhli, Hafaoua Abid, Mohamed Aissaoui, Ilhem Ardhaoui, Nejib Ben Abdallah, Samir Ben Brahim, Imed Ben Ghorbel, Nabila Ben Salem, Soumaya Beji, Said Chamakhi, Adnene Derbel, Fethi Derouiche, Faycal Djait, Taieb Doghri, Yamina Fourti, Faycel Gharbi, Kamel Jellouli, Nabil Jellazi, Kamel Kamoun, Adel Khedher, Amel Letaief, Ridha Limam, Awatef Mekaouer, Riadh Miledi, Khemaies Nagati, Meriem Naouar, Sami Sellem, Hichem Tarzi, Selma Turki, Borni Zidi, Abdellatif Achour, DAVET (Diabetic Albuminuria Vessel Tunisia Study Investigators)
• Journal: Journal of nephrology (J Nephrol) 2010 Jul-Aug Vol. 23 Issue 4 Pg. 415-24 ISSN: 1121-8428 [Print] Italy
• PMID: 20175052 (Publication Type: Journal Article, Multicenter Study)

Chemical References

• Glycosaminoglycans
• glucuronyl glucosamine glycan sulfate

Topics

• Administration, Oral
• Adult
• Aged
• Albuminuria (urine)
• Blood Pressure
• Diabetic Nephropathies (blood, drug therapy, metabolism)
• Female
• Glycosaminoglycans (administration & dosage, adverse effects)
• Humans
• Male
• Middle Aged
• Prospective Studies