title: Sulodexide for kidney protection in type 2 diabetes patients with microalbuminuria: a randomized controlled trial.
abstract: BACKGROUND
  Sulodexide, a heterogenous group of sulfated glycosaminoglycans, includes low-molecular-weight heparin (~80% ± 8%), high-molecular-weight heparin (~5% ± 3%), and dermatan (~20% ± 8%), with a mean molecular weight of ~9 kDa. The drug is absorbed orally and has no anticoagulant effect in the doses used. Small preliminary studies consistently showed sulodexide to be associated with decreased albuminuria in patients with diabetes.
  
  
  METHODS
  We conducted a multicenter placebo-controlled double-blinded study to determine the effect of sulodexide on urine albumin excretion in patients with type 2 diabetic nephropathy.
  
  
  METHODS
  Patients with type 2 diabetes and urine albumin-creatinine ratios (ACRs) of 35-200 mg/g in men and 45-200 mg/g in women were enrolled. Serum creatinine level was <1.5 mg/dL. Blood pressure goal was 130/80 mm Hg. A maximum US Food and Drug Administration-approved dose of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for a minimum of 4 months before randomization was required.
  
  
  METHODS
  The study drug was sulodexide, 200 mg/d.
  
  
  METHODS
  The primary end point was normoalbuminuria (ACR <20 mg/g and a decrease >25%) or 50% decrease in baseline ACR.
  
  
  RESULTS
  In 1,056 randomly assigned patients with a mean baseline ACR of 107.8 ± 83.7 mg/g, comparing the sulodexide versus placebo groups, the primary end point was achieved in 16.5% versus 18.4%; normoalbuminuria, in 7.9% versus 6.1%; and a 50% decrease in albuminuria, in 15.4% versus 17.6%. The relative probability of any given change in albuminuria was identical in both groups.
  
  
  CONCLUSIONS
  We were unable to determine whether the administered sulodexide was absorbed from the gastrointestinal tract.
  
  
  CONCLUSIONS
  Sulodexide failed to decrease urine albumin excretion in patients with type 2 diabetic nephropathy and microalbuminuria.
authors.affiliation: Rush University Medical Center, Chicago, IL, USA. csg@rush.edu
authors.forename: Edmund J
authors.initials: EJ
authors.lastname: Lewis
authors.forename: Julia B
authors.initials: JB
authors.lastname: Lewis
authors.forename: Tom
authors.initials: T
authors.lastname: Greene
authors.forename: Lawrence G
authors.initials: LG
authors.lastname: Hunsicker
authors.forename: Tomas
authors.initials: T
authors.lastname: Berl
authors.forename: Marc A
authors.initials: MA
authors.lastname: Pohl
authors.forename: Dick
authors.initials: D
authors.lastname: de Zeeuw
authors.forename: Hiddo Lambers
authors.initials: HL
authors.lastname: Heerspink
authors.forename: Richard D
authors.initials: RD
authors.lastname: Rohde
authors.forename: Robert C
authors.initials: RC
authors.lastname: Atkins
authors.forename: Anne T
authors.initials: AT
authors.lastname: Reutens
authors.forename: David K
authors.initials: DK
authors.lastname: Packham
authors.forename: Itamar
authors.initials: I
authors.lastname: Raz
mesh_terms: D000419:Albuminuria / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D003928:Diabetic Nephropathies / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006025:Glycosaminoglycans / Q000627:therapeutic use*; D006801:Humans; D007674:Kidney Diseases / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged
chemical_list: D006025:Glycosaminoglycans; C007858:glucuronyl glucosamine glycan sulfate