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- Title
Effects of sulodexide in patients with type 2 diabetes and persistent albuminuria.
- Authors
Hiddo Lambers Heerspink; Tom Greene; Julia B. Lewis; Itamar Raz; Richard D. Rohde; Lawrence G. Hunsicker; Sherwyn L. Schwartz; Stephen Aronoff; Murray A. Katz; Gilbert M. Eisner; James H. Mersey; Thomas B. Wiegmann; for the Collaborative Study Group
- Abstract
Background. Urinary albumin excretion frequently persists in diabetic patients who are treated with angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB). Sulodexide, a glycosaminoglycan mixture of 80% heparan sulfate and 20% dermatan sulfate, has been hypothesized to reduce persistent albuminuria. We have conducted a multi-center randomized double-blind pilot study in order to determine the effect of 6 months’ therapy with sulodexide on urinary albumin excretion and to address logistical issues for a full-scale trial. Methods. A total of 149 patients with type 2 diabetes and an albumin:creatinine ratio (ACR) between 20 and 300 mg/g were randomized with equal allocation to either placebo, 200 mg of sulodexide or 400 mg of sulodexide. The primary endpoint was the achievement, at 6 months, of either 3(1) return to normoalbuminuria (ACR Results. The primary efficacy endpoint was achieved in 25.3% of the patients in the two sulodexide groups combined versus 15.4% of the placebo-treated patients (P = 0.26). The primary endpoint was achieved in 33.3% (P = 0.075 for the comparison to placebo) in the sulodexide 200 mg group and 18.4% (P = 0.781) in the sulodexide 400 mg group. (No consistent patterns of side effects were observed. Conclusion. Based on the experience gained in this pilot study, one full-scale trial is currently being conducted to evaluate the effects of sulodexide on change in ACR in patients with persistent microalbuminuria, and a longer-term trial is underway to evaluate the effects of sulodexide on long-term renal disease progression in patients with overt proteinuria.
- Subjects
URINALYSIS; ALBUMINS; ANGIOTENSINS; DIABETES
- Publication
Nephrology Dialysis Transplantation, 2008, Vol 23, Issue 6, p1946
- ISSN
0931-0509
- Publication type
Article