Table 1.
Clinical trials testing antiproteinuric effects of sulodexide in diabetes patients
| Patients (n) | Mean age*, y | Type of patients | Baseline proteinuria* | Mean arterial pressure before treatment, mmHg | Dose | Duration of treatment | Main results | References |
|---|---|---|---|---|---|---|---|---|
| 54 | 32.1 | Type 1 DM | 24.5 g/d | <120.6–123.9 | 600 lipoprotein lipase-releasing units/day IM 5 days/week | 3 weeks | Significant reduction of albuminuria in 90% of patients, slower in macroalbuminuric patients | Dedov et al18 |
| 223 | 47.4 | Type 2 and type 1 DM | 38.9 g/d | 136.1 | 50 mg/d, 100 mg/d, or 200 mg/d PO | 4 months | Dose-dependent reduction in albumin excretion rate | Gambaro et al22 |
| 43 | 34.6 | Type 1 DM | 126.1 mg/d | N/A | 120 mg/d PO | 6 months | Reduction in albuminuria and NAG excretion, increase in renal vascular function | Sulikowska et al19 |
| 149 | 64.1 | Obese type 2 DM with proteinuria resistant to therapy with ACEI or ARBs | 124.8 mg/d | 130 | 200 or 400 mg/d PO in addition to ACEI or ARBs | 6 months | 23.3% and 33.3% of the patients respectively in the two sulodexide groups combined and in the 200 mg/d group achieved a significant reduction or normalization of albuminuria vs 15.4% of the patients in the control group (P=0.06 and P=0.07, respectively) | Heerspink et al21 |
| 62 | 60.3 | Type 2 DM | N/A | 134.4 | 600 lipoprotein lipase-releasing units/day IV 250 lipoprotein lipase-releasing units/day, PO | 3 weeks 5 weeks |
Significant decrease in urinary albumin excretion rate | Kang20 |
| 986 | 59.0 | Type 2 DM | 2.9 g/d* | 98–102 | 200 mg/d, PO | 26 weeks | Any change in albuminuria was identical in sulodexide group and control group | Lewis et al11 |
| 1,248 | 62.0 | Type 2 DM | N/A | 130.7 | 200 mg/d, PO | 18 months | Did not detect any significant differences between sulodexide and placebo | Packham et al12 |
| 75 | 45.5 | Type 2 DM | 2.03 g/d | N/A | 600 LSU IV 250 LSU PO | 20 days 40 days |
Albuminuria was reduced | Bu et al51 |
| 55 | 62.8 | Type 2 DM | 2.23 g/d | N/A | 600 LSU IV 250 LSU PO | 3 weeks 8 weeks |
24-hour urine protein, FIB, and β2-MG were decreased | Liu52 |
| 65 | 50.0 | Type 2 DM | 600.2 mg/d | 140 | 600 LSU IV 200 mg/d PO | 2 weeks 6 weeks |
Relieved albuminuria effectively | Xiong53 |
Note:
*
Data are expressed as the mean value, unless indicated otherwise.
Abbreviations: β2-MG, β2-microglobulin; ACEI, excluding angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; DM, diabetes mellitus; FIB, fibrinogen; IM, intramuscular; IV, intravenous; LSU, livestock unit; N/A, not available; NAG, N-acetyl-beta-D-glucosaminidase; PO, per os (orally); y, years; d, day.