Use of Detravenol in treatment of chronic venous insufficiency of lower limbs

Ponomarev E.A.¹, Strepetov N.N.², Sotnikov I.E.², Vasiliev S.V.², Arnautov V.S.², Kasatkina I.S.², Bukhtenkov A.V.²

1) Department of Hospital Surgery, Volgograd State Medical University, Volgograd,
2) Limited Liability Company «Expert Legal Centre», Moscow, Russia

Objective. The purpose of this study was to prove that Detravenol is not inferior by clinical efficacy to Detralex^® in the course administration in patients presenting with chronic venous insufficiency of the lower extremities caused by lower limb varicose veins.

Patients and methods. Ours was a prospective randomized open-liable comparative trial aimed at determining efficacy and safety of the two drugs in parallel groups with active control. The trial enrolled a total of 106 patients with chronic venous insufficiency of the lower extremities secondary to lower limb varicose veins. The patients took the drug during 60 days twice daily.

The primary outcome measure of efficacy was reduction of the malleolar circumference upon completion of treatment as compared with the baseline values, with the secondary outcome measures being the dynamics of parameters according to the Venous Clinical Severity Score (VCSS), CIVIQ-2 quality of life questionnaire, and the findings of ultrasonographic duplex scanning.

Results. The obtained findings demonstrated efficacy of therapy with the use of Detravenol in treatment of patients with chronic venous insufficiency of the lower limbs. The 60-day therapy with the study drug resulted in decreased oedema of the lower extremities: the malleolar circumference reduced averagely by 4%, the composite index of the venous clinical severity score diminished averagely by 50%, and the subjective measure of quality of life increased. Patients taking the study drug demonstrated positive dynamics according to the findings of ultrasonographic duplex scanning, with no serious adverse events during the trial observed.

Conclusions. By the primary outcome measure of efficacy (reduction of the malleolar circumference) therapy using the investigational drug proved to be not inferior to therapy with the comparator drug. By the secondary outcome measures the compared therapies appeared equally effective. The study drug and the comparator were found to have a similar safety profile.

KEY WORDS: chronic venous insufficiency, varicose veins, clinical trial, hesperidin, diosmin.

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