Efficacy And Safety Of Trombless Neo And Detralex In The Treatment Of Chronic Venous Diseases Are The Results Of An Open-Label, Comparative, Multicenter Randomized Prospective Study
Abstract
G.N. Gildeeva, A.V. Belostotsky, O.V. Gridnev, V.I. Yurkov.
Chronic venous diseases (CVD) of the lower limbs are an acute medical and social problem due to their widespread distribution among a significant part of the population, and patients rarely seek medical help in the early stages of the disease. Medication based on micronized purified flavo¬noid fraction (PMFF) play a leading role in the elimination of CVD symptoms of lo¬wer limbs. The article presents the results of a multi-center open randomized clinical study conducted in Russia on the efficacy and safety (phase III) of the generic drug Trombless® Neo (diosmin+hesperidin) in comparison with the reference product Detralex® with the participation of 130 patients with symptomatic CVD of lower limbs C2-C3 class of the CEAP classification. The results of the study indicate no less efficacy and comparable safety of Trombless® Neo in relation to changes (decrease) in the severity of CVD symptoms after a 60-day course of therapy.