title: Effect of sulodexide in patients with non-proliferative diabetic retinopathy: diabetic retinopathy sulodexide study (DRESS).
abstract: OBJECTIVE
  To evaluate the effectiveness of sulodexide for the treatment of hard exudates (HE) in non-proliferative diabetic retinopathy (NPDR).
  
  
  METHODS
  This was a randomized, placebo-controlled, multicenter trial involving 130 patients (65 for each group) who had mild-to-moderate NPDR with macular HE. Participants were given a daily dose of either 50 mg sulodexide or a matching dose of placebo orally for 12 months. Main outcome measure was an improvement in HE defined as a decrease in severity by at least two grades on a 10-grade severity scale. This was evaluated by fundus photography over 12-month period.
  
  
  RESULTS
  The sulodexide group showed significantly greater improvement in HE severity than that shown by the placebo group (39.0 % vs. 19.3 %; chi square, P = 0.005). Logistic regression analysis yielded an odds ratio of 2.790 (95 % confidence interval, 1.155-6.743; P = 0.023) for the effect of treatment once adjustments were made for demographic, prognostic and disease confounders. Intention to treat and per-protocol analysis yielded similar results. Sulodexide's safety was comparable to that of the placebo.
  
  
  CONCLUSIONS
  Oral sulodexide therapy over 12 months improved macular HE in patients with mild-to-moderate NPDR, without leading to detectable adverse events. The study protocol was registered on clinicaltrial.gov under identifier NCT01295775.
authors.affiliation: Department of Ophthalmology, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Ji Hun
authors.initials: JH
authors.lastname: Song
authors.forename: Hee Seung
authors.initials: HS
authors.lastname: Chin
authors.forename: Oh Woong
authors.initials: OW
authors.lastname: Kwon
authors.forename: Su Jin
authors.initials: SJ
authors.lastname: Lim
authors.forename: Ha Kyoung
authors.initials: HK
authors.lastname: Kim
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000627:therapeutic use; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D006025:Glycosaminoglycans / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D014792:Visual Acuity / Q000502:physiology
chemical_list: D000925:Anticoagulants; D006025:Glycosaminoglycans; C007858:glucuronyl glucosamine glycan sulfate
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