Table 2.
Large-scale, real-world studies of vasoactive drugs in patients with chronic venous disease
| Study, year | Design | Patients | n | Treatment | Follow-up | Key findings |
|---|---|---|---|---|---|---|
| Diosmin | ||||||
| STATUS study, 2020 [53] | Multicentre, prospective, observational | CEAP C1–C3 | 2013 | Diosmin 600 mg OD (98%) or BID (2%) | 2 months | Symptom improvement and high satisfaction with treatment |
| MPFF | ||||||
| RELIEF study, 2002 [51] | Multicentre (23 countries), prospective, observational | CEAP C0–C4 | 4527 | MPFF 1000 mg/day | 6 months |
Significant reduction in symptom severity Significant decrease in number of patients with C3 or C4 class CVD Significant improvement in QoL |
| DECIDE survey, 2011 [52] | Multicentre (1323 centres in France), prospective, observational | Symptoms of CVDa | 9954b |
MPFF 500 mg/day (89%) Other VAD (5%) No treatment (2%) No information (4%) |
63 days |
Significant decrease in number of symptoms with MPFF Significant improvement in symptoms by physician global impression score Significantly greater improvement in QoL with MPFF vs. other VADs |
| VEIN ACT Program, 2019 [48] | Multicentre (567 centres in Austria, Central America, Colombia, Romania, Russia, and Spain), prospective, observational | CEAP C0–C6 | 7397 | MPFF (93%), diosmin (6%) | 4 to > 12 weeks |
Number and severity of symptoms decreased with treatment 97% of patients reported symptom relief with treatment |
| VEIN STEP Program, 2022 [55] | Multicentre, (Morocco, China and Romaniac), prospective, observational | Symptomatic CVD (CEAP C0–C6) | 4718 | MPFF (74%), diosmin (20%) | 4 weeks | Treatment with VADs, primarily MPFF, was associated with an improvement in symptoms, signs and QoL in patients with CVD |
| Ruscus extract | ||||||
| Guex et al., 2008 [50] | Multicentre (149 centres in Argentina), prospective, observational | CEAP C0–C3 | 1036 | Ruscusd 150 mg TID | 12 weeks |
Significant improvements in QoL Significant reduction in oedema (ankle volume) Symptoms improved in 53.1–76.9% of patients |
| Sulodexide | ||||||
| ACVEDUCT Program, 2020 [49] | Multicentre (205 centres in Russia), prospective, observational | CEAP C1–C6 | 2263 | Sulodexide 600–1200 LSU/day as IV or IM injection and/or 250–1000 LSU/day as capsules | Mean 46.8 months | Significant reduction in the number and severity of symptoms with treatment |
BID twice daily, CEAP Clinical, Etiological, Anatomical, Pathological (score), CVD chronic venous disease, IM intramuscular, IV intravenous, LSU lipasaemic units or lipoprotein lipase-releasing units, MPFF micronized purified flavonoid fraction, OD once daily, QOL quality of life, TID thrice daily, VAD venoactive drug
aCEAP class not assessed in this study, but all patients were symptomatic and class C0–C3
bPatients with baseline and follow-up results (a total of 13,131 patients with CVD were enrolled and completed baseline assessments)
cThe VEIN STEP program is being conducted in nine countries, but only data from Morocco, China and Romania have been published to date
dEach capsule contained Ruscus 150 mg, hesperidin 150 mg, and ascorbic acid 100 mg; patients took 3 capsules per day