[Sulodexide and micronized purified flavonoid fraction in the pharmacotherapy of varicose vein disease: a focus on vein-specific inflammation].

BACKGROUND

Varicose vein disease of the lower extremities is a common vascular disorder associated with endothelial dysfunction, chronic inflammation, and venous wall remodeling. A promising therapeutic approach is pharmacotherapy aimed at modulating vein-specific biomarkers, including E-selectin, MCP- 1, VEGF, MMP-2, and MMP-9.

OBJECTIVE

To evaluate the effects of micronized purified flavonoid fraction (MPFF), sulodexide, and their combination on key biomarker levels and quality of life in patients with VVDLE, depending on the clinical stage (C2-C6).

MATERIAL AND

METHODS

This prospective comparative study included 198 patients (68.2% female; mean age 43.0±8.72 years; BMI 22.0±2.9 kg/m ), allocated into four groups: compression therapy, MPFF 1000 mg/day, sulodexide 250 LSU twice daily, and MPFF plus sulodexide. Treatment duration was 2 months, with a follow-up period of 12 months. Biomarkers were assessed using the enzyme-linked immunosorbent assay method at visits V0, V2, and V3; quality of life was evaluated using the CIVIQ-20 and SF-36 questionnaires.

RESULTS

In C2-C3 patients, MPFF showed the greatest efficacy, with sustained reductions in E-selectin ( 25.4%), MCP-1 (-24.5%), and VEGF (-20.8%) (p<0.001), accompanied by quality-of-life improvement. In C4-C6, sulodexide achieved pronounced and prolonged MMP-9 reduction (-53.8% at 2 months; -24.9% at 12 months) and quality-of-life enhancement. The combination therapy in C4-C6 patients reduced all biomarkers by month 1 and maintained decreases in MMP-2 (-18.2%) and MMP-9 (-24.3%) at 12 months, with persistent CIVIQ-20 and SF-36 improvement. In C2-C3, combination therapy provided no additional benefit and was associated with a higher adverse event rate (28%).

CONCLUSION

Pharmacotherapy efficacy depends on the stage of VVDLE: MPFF is optimal at early stages, while sulodexide or its combination with MPFF is preferable for advanced disease. A personalized treatment approach enables maximal clinical and biochemical benefits with a comparable safety profile.