Rush University Medical Center, Chicago, IL, USA.
Am J Kidney Dis. 2011 Nov;58(5):729-36. doi: 10.1053/j.ajkd.2011.06.020. Epub 2011 Aug 26.
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.
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.
SETTING & PARTICIPANTS: 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.
The study drug was sulodexide, 200 mg/d.
OUTCOME & MEASUREMENTS: The primary end point was normoalbuminuria (ACR <20 mg/g and a decrease >25%) or 50% decrease in baseline ACR.
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.
We were unable to determine whether the administered sulodexide was absorbed from the gastrointestinal tract.
Sulodexide failed to decrease urine albumin excretion in patients with type 2 diabetic nephropathy and microalbuminuria.
舒洛地特是一种不均一的糖胺聚糖硫酸酯混合物，包含低分子量肝素（80%±8%）、高分子量肝素（5%±3%）和硫酸皮肤素（20%±8%），平均分子量为9 kDa。该药口服吸收，在所用剂量下无抗凝作用。小型初步研究一致表明，舒洛地特可降低糖尿病患者的白蛋白尿。
我们进行了一项多中心安慰剂对照双盲研究，以确定舒洛地特对 2 型糖尿病肾病患者尿白蛋白排泄的影响。
纳入 2 型糖尿病患者，男性尿白蛋白肌酐比（ACR）为 35-200 mg/g，女性为 45-200 mg/g，血清肌酐水平<1.5 mg/dL。血压目标为 130/80 mmHg。在随机分组前，需要至少 4 个月使用美国食品和药物管理局批准的最大剂量血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂。
研究药物为舒洛地特，200 mg/d。
主要终点为正常白蛋白尿（ACR<20 mg/g 且下降>25%）或 ACR 基线下降 50%。
在 1056 名随机分配的患者中，平均基线 ACR 为 107.8±83.7 mg/g，与舒洛地特组相比，安慰剂组主要终点的发生率分别为 16.5%和 18.4%；正常白蛋白尿分别为 7.9%和 6.1%；白蛋白尿减少 50%，分别为 15.4%和 17.6%。两组任何特定白蛋白尿变化的相对概率均相同。
我们无法确定胃肠道是否吸收了给予的舒洛地特。
舒洛地特未能降低 2 型糖尿病肾病伴微量白蛋白尿患者的尿白蛋白排泄。
