Treatment Of Chronic Venous Disease Research Articles

The operation of Troyanov - Trendelenburg in the modern minimally invasive approach to the treatment of varicose disease with endovenous laser photocoagulation

Despite the widespread and active introduction of new minimally invasive technologies in clinical phlebology, the Troyanov - Trendelenburg operation today is an important step in the extensive complex of various methods of surgical treatment of varicose veins of the lower extremities. This intervention can be performed under local anesthesia with minimal trauma and excellent cosmetic results. The leading position in the treatment of chronic venous diseases currently takes endovenous laser photocoagulation, the implementation of which is being offered now even to patients with complicated and advanced forms of the disease. The combination of Troyanov - Trendelenburg operation and laser thermocoagulation can significantly reduce the risk of downward recanalization of the great saphenous vein, as well as eliminate side effects and complications that occur during traction of the vein. To eliminate technical errors in the course of ligation of great saphenous vein in the area of sapheno-femoral anastomosis under local infiltration anesthesia and to simplify the detection of the target vessel, especially in obese patients with severe subcutaneous fat, we have developed a method for performing Troyanov - Trendelenburg, which decreases the time of the surgical treatment of the mouth section is up to 10-15 min; the risk of possible complications is reduced. In addition, this treatment does not increase the bed-day and recovery periods. It was concluded that the use of a laser beam at the end of the working part of the fiber, previously carried out under ultrasound control directly into the area where the great saphenous vein falls into the deep system, as a visual guide, greatly facilitates the search for the main saphenous vein, especially in obese patients. The operation of Troyanov -Trendelenburg allows you to process all branches of the Delbe beam and eliminate the continued progression of thermally induced thrombosis proximal to the anastomosis, and therefore possible pulmonary thromboembolism from the large subcutaneous vein subjected to laser coagulation.

The Safety and Efficacy of the Use of Cyanoacrylate for the Treatment of Chronic Venous Disease Outside of the Conventional Operation Room

The Safety and Efficacy of the Use of Cyanoacrylate for the Treatment of Chronic Venous Disease Outside of the Conventional Operation Room

The Use of Micronized Purified Flavonoid Fraction for Postoperative Symptoms Regression After Endovenous Thermal Ablation. A Randomized Controlled Study

Introduction: Micronized purified flavonoid fraction (MPFF) is a venoactive agent with proven positive effects in the treatment of chronic venous disease. The aim of our study was to assess the use of MPFF for the post-operative symptoms relief after endovenous thermal ablation (EVTA) with phlebectomies. Methods: 120 patients undergoing EVTA (Laser 1470nm or Radiofrequency) of the greater saphenous vein with phlebectomies were randomized in two groups: group 1 (60 patients) receiving MPFF 500mg Bid 7 days before and 30 days after the procedure; and group 2 (60 patients) not receiving MPFF (Control group). Demographics (age, gender), intra-operative details such as (type of ablation, linear endovenous energy density, vein diameter and length of ablated vein), Clinical -Etiology- Anatomy- Pathophysiology (CEAP) clinical classification, 10-cm Visual Analog Scale (VAS) for pain, Venous Clinical Severity Score (VCSS) and Chronic Venous Insufficiency Quality-of-Life Questionnaire (CΙVIQ) were recorded. Follow up visits were performed at 7 days prior to ablation and 7 and 30 days post-ablation. Primary outcome was postoperative pain assessement using the VAS scale and CIVIQ pain score. Secondary outcomes included assessemnt of VCSS and CΙVIQ scores. Results: Patients' demographics, CEAP clinical classification and intra-operative details were not different between the two groups. Mean preoperative VAS and CIVIQ pain score were similar in both groups (5±1.9 and 8.7±3 in the group 1 vs. 5.4±1.7 and 9.4±3.4 in the group 2, respectively; p=0.7). At 30-day follow up an improvent of VAS and CIVIQ pain score was recorded in both groups (0.2±0.5 VAS pain score and 4.5±1.1 CIVIQ pain score in the group 1 vs 1.1±1.3 and 5±1 in the group 2, respectively), (p=0.03). The improvement of VAS and CIVIQ pain scores was higher in the group 1 in comparison to group 2 at 7 day and 30 day postoperatively in realtion to pre-operative status [at 7 days: VAS; group 1 from 5±1.9 to 1.5±1.5 vs. group 2 from 5.4±1.7 to 2.6±1.8 (p=00.4); CIVIQ; group 1 from 8.7±3 to 5±1.2 vs. group 2 from 9.4±3.4 to 5.8±1.8 (p=0.04); at 30 days: VAS; group 1 from 5±1.9 to 0.2±0.5 vs. group 2 from 5.4±1.7 to 1.1±1.3 (p=0.04); CIVIQ; group 1 from 8.7±3 to 4.5±1.1 vs. group 2 from9.4±3.4 to 5±1 (p=0.03)]. Both groups showed a significant improvement in all domains of CIVIQ and VCSS compared to preoperative assessment (p=0.02) at 30-days post-operatively, but there was no difference between the two groups in terms of improvement. Conclusion: Administration of MPFF agent in patients undergoing EVTA may improve postoperative pain. Larger studies are needed to confirm these findings. Disclosure: Nothing to disclose

Translation and Validation of the Swedish Venous Health Questionnaire in Patients with Venous Insufficiency

Introduction: When assessing the treatment of Chronic venous disease (CVD), both treatment outcomes and quality of life are recommended. In a recent study our group translated into Swedish and validated the first disease specific instrument for CVD in Sweden, VEnous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym-Swe). This 26-item instrument even though thorough is tedious in the clinical setting. The VVSymQ instrument is a five-item patient-reported outcome (PRO) that assesses symptoms most important to patients with varicose veins (VV), heaviness, achiness, swelling, throbbing and itching. The instrument is based on the symptom domain of the VEINES-QOL/Sym questionnaire and has been thoroughly validated in English and is used in the Vascular Quality Registry for Varicose veins with two added questions about activity and appearance.The aim of this study was to create a Swedish version of the seven-item VV questionnaire and validate it in a Swedish cohort of patients with venous disease. Methods: The original questionnaire was translated into Swedish and administered to 257 patients consecutively recruited with varying degrees of chronic venous disease. Patients from three private clinics were asked to complete both the VEINES-QOL/Sym-Swe and the VV questionnaire (VVQ) at the first consultation, 1 week later and 8 weeks after surgery. Results: In total 257 patients were included. The mean age was 58.1 ± 15.1 years (range 20 - 93) and 60% of the participants were female. The results showed excellent internal consistency for the VVQ (Cronbach's alpha (α) = 0.87). VEINES-QOL/Sym-Swe and the VVQ correlated well as regards to the item question on appearance as well as when the symptom domain from both questionnaires was compared, demonstrating good construct validity. When the preoperative and postoperative VVQ was compared in the specific domains of heaviness, achiness, throbbing, swelling, itching, appearance, and work impact, improvements were seen (total score change, 9.06 ± 6.17; n = 36; P < .001) from a mean preoperative VVQ score of 14.00 ± 7.18 to a mean postoperative VV questionnaire score of 4.94 ± 4.85.The C-class of the CEAP-classification had no significant correlation with the Swedish VVQ. Conclusion: The Swedish version of the short VV questionnaire is reliable and can be used for Swedish patients treated for varicose veins. Disclosure: Nothing to disclose

Effectiveness and safety of sulodexide in the treatment of venous diseases

This article presents a review of the literature assessing the effectiveness and safety of sulodexide in the prophylaxis of deep vein thrombosis and treatment of chronic venous disease. It was demonstrated that sulodexide is effective and safe in the prophylaxis of deep vein thrombosis and treatment of chronic venous insufficiency with ulcers. Sulodexide is characterized by low frequency of bleeding complications.

Treatment of chronic venous insufficiency of the lower extremities

The article discusses up-to-date concepts of the prevalence, pathogenesis and clinical manifestations of chronic venous diseases and chronic venous insufficiency of the lower extremities. It discusses the current views on the mechanism of action of various phlebotrophic drugs used in the symptomatic treatment of chronic venous diseases of the lower extremities and chronic venous insufficiency, updates data on the advantages of micronized purified flavonoid fraction for the treatment of all clinical classes of chronic venous diseases.

Aescusan: pharmacology, pharmacokinetics and therapeutic characteristics

The article is devoted to Aescusan, a well-studied preparation that is traditionally used in clinical practice for the treatment of chronic diseases of veins, hemorrhoids, postoperative and post-traumatic edema. The main active substance is aescin that is contained in horse chestnut seed extract - Aesculus hippocastanum. The paper presents data of a randomized controlled study demonstrating the efficacy of Aescusan in the treatment of chronic venous diseases and chronic venous edema along with the compression therapy. A number of in vitro and in vivo experimental studies provided convincing proof of efficacy of Aescusan. In particular, they proved the anti-edema, anti-inflammatory and venotonic effect of the preparation. Aescusan improves calcium ions entry into the smooth muscle cell channels in the vascular wall, which increases the venous vascular tone. The anti-inflammatory effect of Aescusan is associated with blockade of prostaglandin F2 (PGF2) release from the venous wall, 5-hydroxytryptamine (5-HT) and histamine antagonism, decreased catabolism of tissue mucopolysaccharides. Conclusion: Aescusan has a pluripotent effect on various pathogenetic mechanisms of chronic venous diseases. It is known for its good tolerability and ease of use, which makes it possible to use the preparation in patients with chronic venous diseases, hemorrhoids, and peripheral post-traumatic edema.

Possibilities of treatment of symptoms of chronic diseases of lower limbs veins

The review presents literature on the epidemiology of chronic venous diseases (CVD) and chronic venous insufficiency (CVI). The main approaches to the choice of conservative therapy for CVD and CVI are presented. The rationality of symptomatic treatment of this category of patients is justified. Data on clinical effects and mechanisms of their realization in the preparation of calcium dobesilate are given. The results of preclinical and clinical studies to assess the efficacy and safety of calcium dobesilate in relation to the symptomatic treatment of CVD and CVI are presented. On the basis of the analysis of literary sources the conclusion on expediency of wide application of calcium dobesilate in phlebological practice is presented.

Nédemax® Mese (Leucoselect®, Lymphaselect®, Bromelain) in the treatment of chronic venous disease: a multicenter, observational study

Nédemax® Mese (Leucoselect®, Lymphaselect®, Bromelain) in the treatment of chronic venous disease: a multicenter, observational study

Sulodexide counteracts endothelial dysfunction induced by metabolic or non-metabolic stresses through activation of the autophagic program.

Endothelial dysfunction (ED) predisposes to venous thrombosis (VT) and post-thrombotic syndrome (PTS), a long-term VT-related complication. Sulodexide (SDX) is a highly purified glycosaminoglycan with antithrombotic, pro-fibrinolytic and anti-inflammatory activity used in the treatment of chronic venous disease (CVD), including patients with PTS. SDX has recently obtained clinical evidence in the "extension therapy" after initial-standard anticoagulant treatment for the secondary prevention of recurrent deep vein thrombosis (DVT). Herein, we investigated how SDX counteracts ED. Human umbilical vein endothelial cells (HUVEC) were used. Metabolic and non metabolic-induced ED was induced by treating with methylglyoxal (MGO) or irradiation (IR), respectively. Bafilomycin A1 was used to inhibit autophagy. The production of reactive oxygen species (ROS), tetrazolium bromide (MTT) assay for cell viability, terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) assay for cell apoptosis, Real-time PCR and Western blot analysis for gene and protein expression were used. SDX protected HUVEC from MGO- or IR-induced apoptosis by counteracting the activation of the intrinsic and extrinsic caspase cascades. The cytoprotective effects of SDX resulted from a reduction in a) ROS production, b) neo-synthesis and release of pro-inflammatory cytokines (TNFα, IL1, IL6, IL8), c) DNA damage induced by MGO or IR. These effects were reduced when autophagy was inhibited. Data herein collected indicate the ability of SDX to counteract ED induced by metabolic or non-metabolic stresses by involving the intracellular autophagy pathway. Our experience significantly increases the knowledge of the mechanisms of action of SDX against ED and supports the use of SDX in the treatment of CVD, PTS and in the secondary prevention of recurrent DVT.

Current Therapeutic Interventions in Lower Extremity Venous Insufficiency: a Comprehensive Review.

Chronic venous disease (CVD), although affecting up to 40% of the US population, is often underdiagnosed by healthcare professionals due to an incomplete understanding of the presenting symptoms. CVD is a common cause of lower extremity pain and discomfort, including aching, cramping, tingling, burning, swelling, heaviness, restlessness, and fatigue, and may lead to significant morbidity if left untreated. The negative impact of CVD on quality of life is well established and the optimization of management strategies is an important area of evolving research. Management of CVD has rapidly evolved over the last two decades with the development of minimally invasive endovenous ablative techniques, now the mainstay of treatment. We discuss the data supporting various methods of CVD treatment with an emphasis on the impact on patient comfort and quality of life. Both radiofrequency ablation (RFA) and endovenous laser therapy (EVLA) are excellent options for treatment of lower extremity venous disease, but RFA is associated with less post-procedure discomfort. Ultrasound-guided foam therapy is best reserved for the adjuvant setting or for patients ineligible for RFA or EVLA.

How Does Chronic Venous Disease Progress from the First Symptoms to the Advanced Stages? A Review.

Risk factors for the development of progression chronic venous disease (CVD) and varicose veins are widespread and include advanced age, excess body weight, sedentary lifestyles and occupations, family history, and pregnancy. Varicose veins and CVD are associated with venous hypertension, venous reflux, dysfunctional venous valves, and vein wall inflammation, though the precise etiologies are unclear. Once venous pathology develops, it can progress through a vicious cycle of inflammation and leukocyte recruitment that leads to further deterioration of vein walls and valves, increased hypertension, and release of additional proinflammatory mediators. Early treatment of symptomatic varicose veins and CVD as well as lifestyle changes can help break the inflammatory cycle and alleviate symptoms. Physicians and patients should be aware of the risk factors for CVD, the treatments and measures available to slow disease progression, and the serious consequences of allowing the disease to progress unchecked.Funding: Servier (France).

Clinical Effectiveness of Mechanochemical Ablation Versus Radiofrequency Ablation for Symptomatic Great or Small Saphenous Vein Reflux

Mechanochemical ablation (MOCA) is a nonthermal technology approved by the Food and Drug Administration for the delivery of sclerosing agents to treat symptomatic saphenous vein reflux. Although the technology is considered durable, its effectiveness compared with radiofrequency ablation (RFA) in the great saphenous vein (GSV) and small saphenous vein (SSV) is ill defined. Data were prospectively collected in the Center for Vein Restoration’s electronic medical record system (NexGen Healthcare Information System, Irvine, Calif) and retrospectively analyzed. Patients were divided into the following treatment categories and stratified by Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) class: MOCA GSV, MOCA SSV, RFA GSV, and RFA SSV. The revised Venous Clinical Severity Score (rVCSS) was used to determine chronic venous disease treatment effectiveness in patients who underwent RFA and MOCA only in the GSV or SSV distributions. Patients with multiple treatment modalities were excluded from the analysis. In addition, the 20-item Chronic Venous Insufficiency Questionnaire (CIVIQ-20) was used to assess quality of life before and after intervention at 1 month. All statistical analyses were performed using GraphPad Prism 7 (GraphPad Software Inc, La Jolla, Calif). Treatment outcomes were assessed using unpaired t-tests and two-way analysis of variance. From January 2015 to December 2017, there were 21,383 patients (34,014 limbs) who underwent thermal or MOCA procedures for chronic venous disease. The average age of the cohort was 57.1 ± 14.04 years, and 73% were female. Patients/limbs were divided into the following groups: MOCA GSV (342/545), MOCA SSV (41/62), RFA GSV (15,069/25,153), and RFA SSV (1450/2087). Preintervention and postintervention rVCSS and CIVIQ-20 data were analyzed at 1 month. All postintervention rVCSS outcomes for RFA in the GSV or SSV demonstrated significant improvement compared with preintervention scores regardless of CEAP class (P ≤ .001). Patients treated with MOCA demonstrated improvement in all CEAP classes accept for C5 MOCA GSV patients and C6 MOCA SSV patients (P ≤ .001). CIVIQ-20 scores at 1 month were similar regardless of treatment modality or treatment outcome. CIVIQ-20 scores ranged from 50 before intervention to 35 after intervention at 1 month. MOCA appears to be as effective as RFA in the GSV across CEAP classes. By rVCSS, MOCA may not be as effective as RFA in patients with C5 and C6 disease in the GSV and SSV distribution, respectively. However, patient-reported outcomes between treatment modalities are similar. MOCA in the SSV appears safe. Further assessment and long-term data are required.

Reference Data from the Vascular Laboratory and Application to Chronic Venous Disease Treatment

Several population studies have described the incidence and prevalence of chronic venous disease (CVD). This prospective study was designed to determine in detail the distribution of reflux and obstruction in all lower limb veins to provide reference data for the management of CVD patients. Consecutive patients presenting to a university vascular clinic and undergoing a duplex ultrasound examination were included in the study. Patients with C2 CVD class or higher regardless of symptoms or cosmetic concerns were evaluated. Every patient received a detailed history and physical examination by a vascular surgeon including all demographic information. All patients then had a bilateral lower extremity venous ultrasound examination for reflux and obstruction. The examination was performed in the standing position with the exception of iliac veins and inferior vena cava, which were assessed in the supine position. Location and extent of reflux, vein diameters, and presence of obstruction were recorded. Obstruction was characterized as partial or complete for each venous segment. History of objectively documented venous thrombosis and findings on ultrasound examination indicating previous thrombosis were noted. There were 491 patients who presented for evaluation. Excluded were 241 patients, of whom 49 had undergone previous treatment and 192 had only C0 or C1 disease bilaterally. The remaining 250 patients were 32.8% male and 67.2% female. The mean body mass index was 28.3 kg/m2 (range, 19.2-44 kg/m2); 55.2% identified as white, 11.2% as black/African American, 23.6% as Hispanic/Latino/Spanish origin, and 0.8% as American Indian/Alaska Native. Asymptomatic patients accounted for 17% of the cohort and symptomatic patients for 83%. Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) class was distributed as 43% C2, 28.8% C3, 15.2% C4, 7.6% C5, and 4.8% C6. In the superficial veins, 70.4% of patients had only unilateral disease; 29.6% had bilateral disease. Axial reflux was found in one vein 53.2% of the time; two veins, 27.6%; three veins, 4.8%; four veins, 4%; five veins, 0.8%; and six veins, 0.4%. Calculation of potential ablations was performed, excluding superficial reflux in 2.6% of limbs with small diameter, 5.6% with segmental reflux, 4.4% with tributary reflux, and 6.0% with nonsaphenous reflux that would receive adjunct procedures including microphlebectomy or ultrasound-guided foam sclerotherapy. These adjunct procedures would account for 18.6% of therapy, whereas 64.0% would be ablative therapy. Past deep venous thrombosis was found in 7.2%; 2.8% had concurrent superficial and deep venous thrombosis. From these data, we can assume that the average patient presenting with venous complaints would have symptomatic disease with great saphenous vein reflux and would require one or two ablations based on the prevalence of saphenous reflux in the population. Patients who had at least one saphenous vein with reflux would have an average of 1.6 ablations/patient.

The Seriousness of Chronic Venous Disease: A Review of Real-World Evidence.

Chronic venous disease (CVD) is a prevalent condition that tends to worsen with age. Patients initially seek treatment to relieve symptoms of leg pain, discomfort, heaviness and swelling, all of which impact their quality of life. As the disease increases in severity to include varicose veins, skin changes, and venous ulcer, the demand for treatment increases while the quality of life further diminishes. The prevalence of CVD is highest in Western countries where it already consumes up to 2% of healthcare budgets. With the aging of the global population, the prevalences of CVD and severe CVD are projected to increase substantially, foretelling unsustainably large increases in the healthcare resources and costs needed to treat CVD patients in the coming decades. Effective venoactive drug treatments and ablation procedures are available that provide symptom relief, improve quality of life, slow disease progression, and promote ulcer healing. In addition, venoactive drug treatments may be highly cost-effective. However, there is evidence that physician awareness of CVD is suboptimal and that many patients with CVD are not being treated or referred to specialists according to established guidelines. To decrease this treatment gap and prevent unnecessary disease progression, international guidelines are available to help physicians consider CVD treatment options and refer patients when warranted. Improved disease awareness and appropriate early treatment may help reduce the coming burden of CVD.Funding: Servier.

Determination of the longitudinal sensitivity of the AVVQ-Brazil Quality of Life Questionnaire to non-surgical treatment of chronic venous disease.

ABSTRACTBackgroundSensitivity determines the efficiency and quality of construction of an assessment measure, but studies of the subject are scarce in the literature.ObjectiveTo evaluate the longitudinal sensitivity of the AVVQ-Brazil to clinical changes after treatment for chronic venous disease (CVD).MethodsA longitudinal intervention study, with 112 chronic venous patients receiving elective treatment, assessed with CEAP, VAPS, AVVQ-Brazil, and VEINES-QOL/Sym at pre-treatment (baseline) and post-treatment (4 weeks). Differences in the scores for the scales at different times were evaluated using Student’s t test for paired samples and Wilcoxon’s z, which were also used to asses individuals by CEAP grade and assessment time. Effect size, confidence intervals, and partial η2 were used to determine the sensitivity of changes in scale scores over time. Correlations between changes in the scores of the same scales and between different scales were measured using Pearson coefficients, Spearman coefficients, and Kendall’s tau-b coefficient.ResultsThe mean age of the patients was 59.51 years. The majority were female (82.1%), with standing for prolonged periods (49.1%), had completed secondary (22.3%) or higher (25%) education, and had CEAP C2 (28.6%) or C6 (32.1%) clinical severity. The following results were observed: mean scale scores reduced from baseline to post-treatment, except for the Extent of Varicosities domain of the AVVQ-Brazil and the VEINES-QOL/Sym scales; sensitivity was low for the AVVQ-Brazil and its domains and for the VAPS, and was from low to high for the other scales; there were improvements or maintenance of CEAP grade after treatment; and moderate to excellent correlations between changes in scale scores over time.ConclusionsThe AVVQ-Brazil is sensitive to longitudinal clinical changes after treatment for CVD and is an important measure for assessment of QoL and of disease severity in Brazil.

Attempts at The Creation of a Prosthetic Venous Valve in The Treatment of Chronic Venous Disease

Attempts at The Creation of a Prosthetic Venous Valve in The Treatment of Chronic Venous Disease

Impact of chronic venous disease on quality of life: Results of vein alarm study.

Chronic venous disease (CVD) affects millions of people and negatively impacting the patient's quality of life (QoL) and most of the patients are diagnosed with CVD in advanced stages. The impact of newly diagnosed CVD on QoL has not been evaluated by other studies in Romania. The aim of this study was to assess the QoL for adult patients newly diagnosed with CVD addressing to the General Practitioner's (GP) office in Romania between June to August 2016. Patients included in the study were adult, signing the inform consent form, newly diagnosed with CVD or patients diagnosed with CVD, without CVD treatment the past 6 months. Data on demographic distribution, risk factors, clinical profiles, CVD symptomatology, QoL parameters, as well as pharmacological management practice were collected. The study included 1,893 patients (79.08% females) with 50.4% of patients in the age group 51-70 years. The most frequent CVD symptoms reported, were heavy leg sensation (85.74%), swelling of the feet (77.28%) and pain (73.11%). The most frequent CVD signs were telangiectasia and reticular veins (79.19%), varicose veins (65.77%) and edema (53.35%). The clinical, aetiological, anatomical and pathophysiological (CEAP) classification placed most of the patients in C3 class (31.85%), followed by C2 class (28.00%), C1 class (21.02%) and C4a (8.87%). Most of the patients reported 'low' or 'moderate' intensity of the CVD symptoms. QoL was affected for most of the patients at 'a mild' or 'moderate' degree, being noticed as a significant negative impact on physical, psychological, and social functioning components of QoL, correlated with CEAP class (P<0.001). Data regarding correlation of CEAP class, CVD symptoms and impact on QoL identified a significant correlation between all analyzed components (P<0.001). Study results prove that CVD diagnosis was established with relative delay and CVD is negatively affecting patients' QoL. Additional research will be needed to identify the long-term impact of CVD on QoL of the affected patients and their families.

Pharmacotherapy of chronic vein diseases. New European guidelines

The 19th Annual Meeting of the European Venous Forum held in the city of Athens in 28-30 June 2018 presented the long-awaited updated guidelines for the diagnosis and treatment of chronic venous diseases (CVD), the full text of which can be found in the June issue of International Angiology Journal. This publication aims at acquainting practitioners with one of the key sections of the new European guidelines devoted to the pharmacotherapy of CVD.

Clinical efficacy of once-daily micronized purified flavonoid fraction 1000 mg tablet in patients with symptomatic chronic venous disease

Aim: To investigate the clinical efficacy of micronized purified flavonoid fraction (MPFF) 1000 mg given as a single 1000 mg tablet once daily in patients suffering from chronic venous disease (CVD) vs MPFF 500 mg twice daily.Methods: In an international, randomized, double-blind, parallel-group study, patients classified C0s to C4 according to Clinical Etiological Anatomic Pathophysiologic [CEAP] classification and with leg pain graded as superior to 4 cm on a 10-cm visual analog scale (VAS), were treated for 8 weeks with either MPFF 1000 mg once daily or MPFF 500 mg twice daily. The present post-hoc analysis focuses on the effect of treatment over time in patients randomized to the MPFF 1000 mg group. Leg pain was assessed at each follow-up visit by VAS. VAS scores over time were compared between each visit using paired Student t-tests.Results: In total, 87 patients out of 174 were randomized to the MPFF 1000 mg group. Mean age ± SD was 49.1 ± 12.2 years, most of the patients were female (81.6%), the main CEAP classes of the most affected leg were C1 (20.7%), C2 (39.1%), C3 (33.33%), and the mean duration of CVD was 14.6 ± 10.9 years. Patients with previous CVD treatment represent 27.6% of the patients. A MPFF 1000 mg tablet once daily was associated with a significant and continuous reduction in leg pain throughout the treatment period: –1.54 cm (±1.45) from baseline to week 2 (p < .01), –1.11 cm (±1.06) from week 2 to week 4 (p < .01), –1.57 cm (±1.05) from week 4 to week 8 (p < .01).Conclusions: The new MPFF 1000 mg dose regimen in once daily tablets was associated with a rapid and continuous reduction in leg pain throughout the 8-week treatment period.