Aim: To assess the impact of long-term Diosmin/Hesperidin use in the treatment of proximal deep vein thrombosis (DVT).
Methods: This study was a pilot randomized open-label study with blinded outcome assessor - enrolled patients with their first episodes of popliteal-femoral DVT confirmed by duplex ultrasound (DUS). All participants were randomized into two groups: 1.) control that received a standard treatment with oral Rivaroxaban, and 2.) experimental that required additional treatment with Diosmin/Hesperidin 450/50 mg twice a day. Both drugs were used for six months. Patients were followed-up for the whole treatment period with series DUS every two months in order to evaluate the degree of recanalization by popliteal (PV), superficial femoral (SFV), and common femoral (CFV) veins' compressibility. Thrombi extension was assessed by modified Marder score. At the end of the follow-up period, patients were assessed with Villalta and venous clinical severity scores. Post-thrombotic syndrome (PTS) was diagnosed in those who had ≥5 Villalta score.
Results: Sixty patients were randomized to the control and experimental groups (n=30 in each group). There were 40 men and 20 women with mean age of 56.3±13.4. Clinically unprovoked DVT was recognized in 65% of cases and left side localization in 45%. The median of Marder baseline scores were 15.0±4.8 and 11.1±4.3 in the experimental and control groups, respectively (p=0.002). After six months of treatment, the Marder score decreased to 0.8±1.6 and 2.8±3.5 in the main control groups, respectively (p=0.006). The generalized linear model repeated measures found a greater reduction in the Marder score (р <0.0001) and increased speed of recanalization on SFV (р <0.0001) with a non-significant tendency in the CFV (p=0.130) and PV (p=0.204) in the experimental group compared to the control one. Full recanalization of the PV at six months was observed in 24 patients (80%), who had received Diosmin/Hesperidin, and only in 17 persons (57%) of the control group (p=0.047).
The median of Villalta score in the group treated with Diosmin/Hesperidin was significantly lower compared to the control one (2.9±2.7 versus 5.8±3.0 [p <0.0001]). The same difference was found for VCSS score (2.3±1.9 versus 4.9±1.9 [p <0001]). According to the Villalta score, PTS was recognized in six patients (20%) and 17 patients (57%) in the experimental and control groups, respectively (p=0.004).
Conclusion: Long-term treatment with Diosmin/Hesperidin can increase the speed of deep vein recanalization and reduce the incidence of PTS diagnosed at six months in patients with proximal DVT treated with oral rivaroxaban.
Lobastov:Bayer: Honoraria, Speakers Bureau; Servier: Honoraria, Speakers Bureau. Schastlivtsev:Bayer: Honoraria, Speakers Bureau; Servier: Honoraria, Speakers Bureau. Barinov:Bayer: Honoraria, Speakers Bureau; Servier: Honoraria, Speakers Bureau.
Asterisk with author names denotes non-ASH members.