Treatment of Truncal Incompetence and Varicose Veins with a Single Administration of a New Polidocanol Endovenous Microfoam Preparation Improves Symptoms and Appearance
J T King, M O'Byrne, M Vasquez, D Wright, VANISH-1 Investigator Group, R Beyer, A Comerota, E Cummings, S Daugherty, K Deck, B Ferris, A Fleisher, A Jones, L Kabnick, J Laredo, S Murray, M O'Byrne, J Regan, M Rosenblatt, C Shortell, A Soffer, A Gasparis, G Munavally, E Sanchez, M Vasquez, J T King, M O'Byrne, M Vasquez, D Wright, VANISH-1 Investigator Group, R Beyer, A Comerota, E Cummings, S Daugherty, K Deck, B Ferris, A Fleisher, A Jones, L Kabnick, J Laredo, S Murray, M O'Byrne, J Regan, M Rosenblatt, C Shortell, A Soffer, A Gasparis, G Munavally, E Sanchez, M Vasquez
Abstract
Objective: This multicenter, parallel group study was designed to determine if a single administration of ≤15 mL of pharmaceutical-grade polidocanol endovenous microfoam (PEM, now approved in the United States as Varithena [polidocanol injectable foam], BTG International Ltd.) could alleviate symptoms and improve appearance of varicose veins in a typical population of patients with moderate to very severe symptoms of superficial venous incompetence and visible varicosities of the great saphenous vein (GSV) system.
Methods: The primary endpoint was patient-reported venous symptom improvement measured by change from baseline to Week 8 in 7-day average VVSymQ score. Co-secondary endpoints measured improvement in appearance of visible varicose veins from baseline to Week 8, as measured by the Independent Photography Review-Visible Varicose Veins (IPR-V(3)) and Patient Self-assessment of Visible Varicose Veins (PA-V(3)) scores. Patients were randomized to five groups: PEM 0.125% (control), 0.5%, 1%, 2%, or placebo. Adverse events (AEs) were recorded at each study visit. Tertiary endpoints measured duplex ultrasound response, changes in venous clinical severity score, and the modified Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms.
Results: At Week 8, VVSymQ scores for the pooled PEM group (0.5% + 1% + 2%; p < .0001) and individual dose concentrations (p < .001) were significantly superior to placebo. Mean changes from baseline to Week 8 in IPR-V3 and PA-V(3) scores were significantly greater for pooled PEM than for placebo (p < .0001). Most AEs were mild and resolved without sequelae. No pulmonary emboli were reported.
Conclusions: This study demonstrated that a single administration of up to 15 mL of PEM is a safe, effective, and convenient treatment for the symptoms of superficial venous incompetence and the appearance of visible varicosities of the GSV system. Doses of 0.5%, 1%, and 2% PEM appear to have an acceptable risk-benefit ratio.
Trial registration: ClinicalTrials.gov NCT01072877.
Keywords: Polidocanol endovenous microfoam; Polidocanol injectable foam; Varicose veins.
Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.
Source: PubMed