Table 1.
Characteristics of studies.
Study author | Country | Design | Subjects | Patients(n) S/C | Age (m, y) S/C | Male n, (%) | Intervention groups S/C | Follow-up | Outcomes |
---|---|---|---|---|---|---|---|---|---|
Andreozzi et al., 2015 | Italy | RCT | Patients with unprovoked proximal DVT or pulmonary embolism treated with anticoagulant therapy. Age ≥ 18 year | 307/308 | 55.7/55.9 | 175 (57%) | Sulodexide 500 LSU PO twice daily vs. Placebo | 24 months | 1. The primary efficacy outcome was recurrent DVT or pulmonary embolism. 2. Secondary efficacy outcomes included distal or superficial vein thrombosis and nonfatal or fatal MI, stroke, or acute ischemia of the lower limbs. 3. Safety outcome was major or clinically relevant nonmajor bleeding. |
Cirujeda and Granado, 2006 | Spain | RCT | Patients with proximal DVT of the lower limbs treated with anticoagulant therapy. Age ≥ 18 year | 75/75 | 67.7/66.1 | 92 (61.3%) | Sulodexide 300 LSU PO twice daily vs. Acenocoumarol 2 mg/day | 6 months | 1. The primary efficacy outcome was recurrent DVT or pulmonary embolism. 2. Safety outcome was possible hemorrhagic episodes |
Errichi et al., 2004 | Italy | RCT | Patients with DVT treated with anticoagulant therapy. | 202/203 | 53.2/52.2 | NR | Sulodexide 500 LSU PO twice daily vs. Placebo | 24 months | 1. The primary efficacy outcome was recurrent DVT or pulmonary embolism. 2. Secondary efficacy outcomes included distal or superficial vein thrombosis and nonfatal or fatal MI, stroke, or acute ischemia of the lower limbs. 3. Safety outcome was major or clinically relevant nonmajor bleeding. |
Luzzi et al., 2014 | Italy | PC | Patients with proximal DVT | 124/167 | 47.2/46.4 | 131 (45.0%) | Sulodexide 500 LSU PO twice daily vs. Placebo | 60 months | 1.The primary efficacy outcome was recurrent DVT or pulmonary embolism. 2.Safety outcome was possible hemorrhagic episodes |
S, sulodexide group; C, control group; PO, per os; NR, not reported.
DVT, deep vein thrombosis; LSU, lipoprotein lipase releasing units.
RCT, prospective randomized controlled trials; PC, prospective non-randomized controlled study.