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

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]).

Keywords: Varicose veins; great saphenous vein incompetence; patient-reported outcome measures; patient-reported outcomes; polidocanol; polidocanol injectable foam; saphenofemoral incompetence; saphenous vein; self report.

Figure 1.

Patient disposition.

Figure 2.

Absolute value of mean change in score from Baseline at Week 8 for endpoints with a scale of 0–100.