Table 2.
Clinical studies of mesoglycan in patients with chronic venous disease
| References | Study design | Patient type | N | Treatment | Study duration | Main outcomes |
|---|---|---|---|---|---|---|
| Aluigi et al. [70] | Prospective, OL, observational | Varicose veins associated with CVI and/or CVI | 202 | Mesoglycan 100 mg/day PO | 3 months | Significant reduction in CVD symptoms and edema severity vs baseline (p < 0.001) |
| La Marca et al. [74] | Prospective, randomized, OL | CVD with ulcer | 40 | Topical mesoglycan 1–2 vials/day (n = 20) vs plant stimulins (n = 20) | 60 days | Ulcer healing rate was 95% with mesoglycan vs 80% with plant stimulins |
| Arosio et al. [72] | Randomized, DB, placebo controlled | CVD—(C5-C6) | 183 | Mesoglycan 30 mg/day IM for 3 weeks then 100 mg/day PO (n = 92) or placebo (n = 91) | 24 weeks | Significantly higher rate of ulcer healing (p < 0.05) and earlier ulcer healing vs placebo (90 vs 136 days, respectively); significantly better HRQoL (SF-36) in patients with healed vs unhealed ulcers (p < 0.05) |
| Andreozzi, [71] | Retrospective | DVT | 83 | Mesoglycan 100 mg/day PO | 3 years | Low rate of DVT recurrence (cumulative rate of 14.3%) |
| (CEAP C3, C4 or C6) | 182 | 3 years | Significant reduction in severity of edema, pain, and disability vs baseline in C3 and C4 patients (p < 0.00001) | |||
| Allegra et al. [68] | Prospective, OL, observational | (CEAP C2, C3 or C4a) | 1483 | Mesoglycan 50 mg BID PO | 30 days | Significant improvement in HRQoL (SF-36) vs baseline (p < 0.001); significant reduction in CVD severity (edema, hyperpigmentation, or eczema) vs baseline (p < 0.0001) |
| Allegra et al. [69] | Prospective, OL, observational | (CEAP C2 or C3) | 1066 | Mesoglycan 50 mg BID PO | 2 months | Significant improvement in HRQoL (CIVIQ-20) vs baseline; significant reduction in edema vs baseline |
| Maresca et al. [75] | Prospective, OL, comparative | Women (CEAP C1 to C4) | 75 | Mesoglycan 50 mg BID (n = 37) or standard care (n = 38) | 90 days | Peak skin microcirculation on LDF significantly increased vs baseline with mesoglycan (p = 0.007) and vs standard care (p < 0.005) |
| Kontothanassis et al. [73] | Prospective, OL, observational | (CEAP C2 or worse) | 316 | Mesoglycan 50 mg BID PO | 2 months | Low rate of postoperative venous thrombosis (0.8%) |
BID twice daily, CEAP Clinical-Etiological-Anatomical-Pathological [classification system], CIVIQ-20 20-item Chronic Venous Insufficiency Quality of Life Questionnaire, CVD chronic venous disease, CVI chronic venous insufficiency, DB double blind, DVT deep vein thrombosis, HRQoL health-related quality of life, IM intramuscular, LDF laser Doppler flow, NR not reported, OL open label, PO orally, SF-36 Short Form 36