Sulodexide in the Treatment of Chronic Venous Insufficiency: Results of the All-Russian Multicenter ACVEDUCT Program

Abstract

Introduction: Pharmacotherapy is a mainstay of treatment for lower limb chronic venous disease (CVD) and its complications. However, therapeutic agents with evidence-based efficacy for the treatment of CVD are limited. Sulodexide (registered as Vessel Due F in Russia) has confirmed therapeutic efficacy in patients with moderately severe or late-stage CVD, but real-world evidence of its use in Russian patients with initial manifestations of chronic venous insufficiency (CVI) remains scarce.

Methods: Data concerning the use of sulodexide in Russian patients with CVD in routine clinical practice were collected and assessed within the framework of the ACVEDUCT program. This observational, prospective, non-controlled multicenter program included patients routinely prescribed sulodexide, as a solution for injections and/or soft capsules, by their physician in accordance with the registered Russian Federation instructions for use.

Results: In total, 2263 patients took part in the program. The majority of patients were diagnosed as having CEAP class C3 (38.4%) or class C4 (35.6%) CVD. Sulodexide was associated with decreased symptom severity in 56.4% of patients and a decreased number of symptoms in 42.8%. Thus, improvements were observed in 99.2% overall, with the drug effects being apparent as early as 15-20 days after starting treatment. The highest rate of CVD symptom regression was observed in patients aged 30-40 years. There was a significant positive correlation between sulodexide efficacy and treatment duration and the use of capsules during follow-up. A negative correlation was found between treatment efficacy and patient age at diagnosis, CEAP class, the total number of symptoms, and a combination of risk factors.

Conclusions: Sulodexide was an effective, safe, well-tolerated, and pathogenetically substantiated pharmacologic agent for the treatment of patients with lower limb CVD, and therefore should be recommended in patients with early-stage CVD. Patients with venous trophic ulcers require higher doses and prolonged administration of the drug.

Keywords: ACVEDUCT; CEAP class; Chronic venous disease; Chronic venous insufficiency; Efficacy; Observational program; Pharmacotherapy; Risk factors; Sulodexide, Vessel Due F.