[Sulodexide in treatment of chronic venous insufficiency. Results of the All-Russian multicenter programme ACVEDUCT]. / Sulodeksid v lechenii khronicheskoi venoznoi nedostatochnosti. Itogi Vserossiiskoi mul'titsentrovoi programmy ACVEDUCT.

INTRODUCTION: Pharmacotherapy occupies one of the leading places in comprehensive treatment of lower-limb chronic venous diseases (CVD) and their complications. At the same time, there are not so many therapeutic agents intended for treatment of CVD and possessing evidence-based efficacy. Sulodexide (registered in Russia as Vessel Due F) is a drug with a confirmed therapeutic effect in patients with a moderately severe course of chronic venous disease or its late stages. However, the experience of using it in Russia for treatment of patients presenting with initial manifestations of chronic venous insufficiency (CVI) is still scarce. PATIENTS AND METHODS: The data concerning the use of Vessel Due F in the routine practice of treating CVD in Russian patients were collected and assessed within the framework of the ACVEDUCT programme. This observational prospective non-controlled multicentre programme included patients routinely prescribed by their attending physician Vessel Due F as a solution for injections and/or soft capsules in accordance with the registered in the Russian Federation instruction for use. A total of 2,263 patients took part in the programme. RESULTS: The majority of the patients prescribed sulodexide were diagnosed as having CEAP class C3 (38.4%) and class C4 (35.6%) CVD. Treatment was accompanied and followed by a decrease in the symptoms' severity observed in 56.4% of patients and a decrease in the number of symptoms in 42.8% of patients (thus positive dynamics was totally noted in 99.2%), with the effect of taking the drug commencing to manifest itself in patients as early as on day 15-20 of treatment. The highest rate of regression of symptoms of CVD was observed in 30-to-40-year-old patients. A statistically significant positive correlation was revealed between efficacy and the duration of treatment, the use of capsules during the term of follow up, with a negative correlation revealed between efficacy of treatment and the patient's age at which the diagnosis had been made, the stage according the CEAP classification, the total number of symptoms, a combination of risk factors. CONCLUSIONS: Sulodexide proved to be an effective, safe, well-tolerated and pathogenetically substantiated pharmacological agent for treatment of patients presenting with lower-limb CVI and should therefore be recommended for patients at early stages of formation of CVD. Patients suffering from venous trophic ulcers require higher doses and prolonged administration of the drug.

[Multicentre observational study of Phlebodia 600 in treatment of patients with CEAP class C0-C3 chronic venous diseases]. / Mnogotsentrovoe nabliudatel'noe issledovanie primeneniia Flebodia 600 u bol'nykh c khronicheskimi zabolevaniiami ven klassov C0-C3 po CEAP.

The purpose of the study was to evaluate efficacy of Diosmin (Phlebodia 600, Innothera, France) in treatment of patients presenting with class C0s-C3 chronic venous diseases (CVD) according to the CEAP classification. Presented herein are the results of a prospective observational study aimed at assessing the outcomes of two-month administration of Phlebodia 600 (600 mg diosmin) in patients suffering from class C0s-C3 CVD according to the CEAP classification. The study comprised a total of 868 patients, including 175 (20.2%) men and 693 (79.8%) women. Of these, 866 patients completed the study according to the protocol. Amongst the 868 followed-up patients, 851 (98.0%) subjects strictly adhered to the physician's prescription and stopped taking the drug without violation of the regimen and dosing of diosmin. The main drug dosage regimen of diosmin was 1 tablet once a day in 851/868 (98.04%) patients. Satisfaction with treatment with diosmin was reported as 'excellent' by 46.7 % of patients (95% CI: 43.3-50.0) and by 49.4% of physicians (95%: CI 46.1-52.7), being rated as 'good' by 45.0% of patients (95 % CI: 41.7-48.4) patients and by 43.6% of physicians (95% CI: 40.3-47.0). The score for the quality of life of patients according to the CIVIQ-20 scale at the first follow-up visit amounted to 45.4±15.4 points (median 43.0 points). At the second follow-up visit, this parameter improved dramatically, dropping to the level of 35.6±11.5 points (median 33.0 points). By the third follow-up visit, the positive dynamics of the parameters preserved continued, averagely amounting to 28.9±8.7 points (median 26.0 points). A decrease in the circumference of the left and right crura (by 0.39±0.74 and by 0.36±0.75 cm, respectively) was observed at the second follow-up visit. The difference of the malleolar measurements between the first and third follow-up visits amounted to 7.2±9.4 mm and 6.6±9.7 mm for the right and left crus, respectively (p<0.001). The number of patients with a reported feeling of heaviness in the legs statistically significantly decreased from 97.6% at the stage of enrollment into the study to 73.0% after 2 months of therapy, that of those with painful sensations from 84.5 to 55.3%, those with complaints of swelling (oedemas) of the lower limbs from 83.9 to 56.8%, with complaints of convulsions from 71.2 to 35.7%, with complaints of sensation of tingling from 63.4 to 34.1%, respectively. Hence, a statistically significant improvement of the patients' condition was observed as early as 30 days after the beginning of treatment. By day 60, the positive effect of the carried out therapy continued to grow. Safety and good tolerance of the drug were noted, which was confirmed by low incidence of undesirable events and high adherence to treatment.