A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of Varithena® (polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence. (April 2017)

• Record Type: Journal Article
• Authors: Gibson, Kathleen; Kabnick, Lowell
• Is Part Of: Phlebology. Volume 32:Number 3(2017)
• Page Start: 185
• Page End: 193
• Publication Date: 2017-04
• Subjects: Varicose veins -- polidocanol -- self report -- saphenous vein -- polidocanol injectable foam -- patient-reported outcomes -- patient-reported outcome measures -- great saphenous vein incompetence -- saphenofemoral incompetence; Veins -- Diseases -- Periodicals; 616.14
• DOI: 10.1177/0268355516635386
• Languages: English
• ISSNs: 0268-3555

Abstract

Objectives: A randomized, placebo-controlled, multicenter study was conducted to evaluate the safety and efficacy of polidocanol endovenous microfoam (1%, Varithena® [polidocanol injectable foam], BTG International Ltd.). Methods: Patients (n = 77) with symptomatic, visible varicose veins were randomized to treatment with either Varithena 1% or placebo. Results: Varithena provided greater mean changes from Baseline in patient-reported assessments of symptoms (e.g., heaviness, achiness, swelling, throbbing, itching [HASTI®] score 30.7 points vs 16.7 points, p = 0.0009, primary endpoint; and modified Venous Insufficiency Epidemiological and Economic Study-Quality-of-Life/Symptoms [m-VEINES-QOL/Sym; p < 0.001]), physician-assessed VCSS, and physician- and patient-assessed appearance compared with placebo. The HASTI score correlated highly with the modified-VEINES-QOL/Sym and Chronic Venous Insufficiency Questionnaire-2 scores (r = 0.7 to > 0.9, p ≤ 0.001). Adverse events included contusion, incision-site hematoma, and limb discomfort. Venous thrombus adverse events were reported as mild and generally resolved without sequelae. Conclusions: Varithena provided significantly greater symptom relief and improvement in leg appearance compared with placebo. Adverse events were generally mild and transient. (www.clinicaltrials.gov [NCT00758420]).