Andrey V Chupin1, Sergey E Katorkin2, Ivan I Katelnitsky3, Oksana V Katelnitskaya3, Igor I Prostov3, Alexey S Petrikov4, Alexander P Koshevoi5, Larisa F Lyudkova6. 1. Federal Scientific Clinical Centre of the Federal Medical and Biological Agency of Russia, Moscow, Russia. achupin@rambler.ru. 2. Samara State Medical University of the RF Ministry of Public Health, Samara, Russia. 3. Rostov State Medical University of the RF Ministry of Public Health, Rostov, Russia. 4. Altai State Medical University of the RF Ministry of Public Health, Barnaul, Russia. 5. Clinic "SibMedCentre", Tomsk, Russia. 6. Krasnoyarsk Interregional Polyclinic No 1, Krasnoyarsk, Russia.
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.
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.
Entities:
Keywords:
ACVEDUCT; CEAP class; Chronic venous disease; Chronic venous insufficiency; Efficacy; Observational program; Pharmacotherapy; Risk factors; Sulodexide, Vessel Due F