Sulodexide fails to demonstrate renoprotection in overt type 2 diabetic nephropathy.
Sulodexide, a mixture of naturally occurring glycosaminoglycan polysaccharide components, has been reported to reduce albuminuria in patients with diabetes, but it is unknown whether it is renoprotective. This study reports the results from the randomized, double-blind, placebo-controlled, sulodexide macroalbuminuria (Sun-MACRO) trial, which evaluated the renoprotective effects of sulodexide in patients with type 2 diabetes, renal impairment, and significant proteinuria (>900 mg/d) already receiving maximal therapy with angiotensin II receptor blockers. The primary end point was a composite of a doubling of baseline serum creatinine, development of ESRD, or serum creatinine ≥6.0 mg/dl. We planned to enroll 2240 patients over approximately 24 months but terminated the study after enrolling 1248 patients. After 1029 person-years of follow-up, we did not detect any significant differences between sulodexide and placebo; the primary composite end point occurred in 26 and 30 patients in the sulodexide and placebo groups, respectively. Side effect profiles were similar for both groups. In conclusion, these data do not suggest a renoprotective benefit of sulodexide in patients with type 2 diabetes, renal impairment, and macroalbuminuria.
Melbourne Renal Research Group, 73-75 Pine Street, Reservoir, Melbourne, Victoria 3073, Australia. dmpackham@netspace.net.au
David K
DK
Packham
Rory
R
Wolfe
Anne T
AT
Reutens
Tomas
T
Berl
Hiddo Lambers
HL
Heerspink
Richard
R
Rohde
Sara
S
Ivory
Julia
J
Lewis
Itamar
I
Raz
Thomas B
TB
Wiegmann
Juliana C N
JC
Chan
Dick
D
de Zeeuw
Edmund J
EJ
Lewis
Robert C
RC
Atkins
D000368:Aged; D000419:Albuminuria / Q000188:drug therapy* / Q000209:etiology; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003928:Diabetic Nephropathies / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006025:Glycosaminoglycans / Q000627:therapeutic use*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017211:Treatment Failure
D006025:Glycosaminoglycans; D007004:Hypoglycemic Agents; C007858:glucuronyl glucosamine glycan sulfate