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


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.
Blouza
Samira
S
Institut National de Nutrition, Tunis, Tunisia. henda.jamoussi@rns.tn
Dakhli
Sabeur
S
Abid
Hafaoua
H
Aissaoui
Mohamed
M
Ardhaoui
Ilhem
I
Ben Abdallah
Nejib
N
Ben Brahim
Samir
S
Ben Ghorbel
Imed
I
Ben Salem
Nabila
N
Beji
Soumaya
S
Chamakhi
Said
S
Derbel
Adnene
A
Derouiche
Fethi
F
Djait
Faycal
F
Doghri
Taieb
T
Fourti
Yamina
Y
Gharbi
Faycel
F
Jellouli
Kamel
K
Jellazi
Nabil
N
Kamoun
Kamel
K
Khedher
Adel
A
Letaief
Amel
A
Limam
Ridha
R
Mekaouer
Awatef
A
Miledi
Riadh
R
Nagati
Khemaies
K
Naouar
Meriem
M
Sellem
Sami
S
Tarzi
Hichem
H
Turki
Selma
S
Zidi
Borni
B
Achour
Abdellatif
A
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000419:Albuminuria / Q000652:urine; D001794:Blood Pressure; D003928:Diabetic Nephropathies / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism; D005260:Female; D006025:Glycosaminoglycans / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
D006025:Glycosaminoglycans; C007858:glucuronyl glucosamine glycan sulfate