Aims: To investigate the effectiveness and tolerability of adjunctive micronized purified flavonoid fraction (MPFF) in patients with chronic venous disease (CVD). Patients & methods: This observational study included adults (≥18 years) with clinical-etiology-anatomy-pathophysiology (CEAP) class C4 CVD for whom MPFF was indicated. Outcomes included changes in subcutaneous adipose thickness, venous clinical severity score, CVD symptoms (using a visual analogue scale) and tolerability. Results: Of 381 patients, 365 completed the study. After 6 months, subcutaneous adipose tissue thickness, venous clinical severity score and visual analogue scale scores significantly improved (all p < 0.001 vs baseline). No adverse drug reactions occurred. Conclusion: Adjunctive MPFF treatment improves skin and subcutaneous tissue conditions in CVD patients. Clinical Trial Registration: NCT04138576 (ClinicalTrials.gov).
Keywords: chronic venous disease; conservative treatment; flavonoid; micronized purified flavonoid fraction; real-world study; venoactive drugs.
Chronic venous disease (CVD) can cause a range of signs and symptoms that reduce patient quality of life. Micronized purified flavonoid fraction (MPFF) is a type of venoactive drug that is recommended in patients with early and advanced CVD. This study investigated the effectiveness and safety of MPFF when added to conservative treatment in patients with advanced CVD with long-term follow-up. After 6 months of MPFF, we observed significant improvements in the skin and subcutaneous tissue, symptoms and patient quality of life; no adverse drug reactions were reported. Therefore, MPFF-based conservative treatment can effectively and safely treat CVD.