General Information

Varithena (polidocanol injectable foam) is a sclerosant and causes fibrosis inside varicose veins, occluding the lumen of the vessel, and reducing the appearance of the varicosity.

Varithena is specifically indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein system above and below the knee.

Varithena is supplied as a foam for intravenous administration. Varithena should be used under ultrasound guidance only. Use up to 5 ml per injection and 15 ml per treatment session . Treatments sessions should be seperated by a minimum of 5 days.

Mechanism of Action

Varithena (polidocanol injectable foam) is a non-ionic surfactant sclerosing agent. The hydrophobic pole of the polidocanol molecule attaches to the lipid cell membrane of the venous endothelium, resulting in disruption of the osmotic barrier, destruction of the venous endothelium, and vasospasm. Following exposure to polidocanol, the interior surface of the vein becomes thrombogenic, which leads to thrombus formation and venous occlusion. The occluded vein is eventually replaced by fibrous connective tissue. Polidocanol is deactivated upon contact with blood, thus limiting the sclerosant action to the endothelium near the site of injection.

Clinical Trial Results

The FDA approval of Varithena was based on two randomized, blinded, multicenter clinical trials designed to assess the efficacy and safety of Varithena 0.5%, 1.0% and 2.0% (VANISH-1) and Varithena 0.5% and 1.0% (VANISH-2) compared with placebo in the treatment of both symptoms and appearance in patients with SFJ incompetence as evidenced by reflux of the GSV or major accessory veins. In both studies, a Varithena 0.125% treatment group was included as a control for blinding of the duplex ultrasound assessment. A total of 519 subjects were treated in both trials. For both clinical trials, the primary efficacy endpoint was improvement in patient symptoms, as measured by the change from baseline to Week 8 in the 7-day average electronic daily diary VVSymQ score. In VANISH-1, subjects treated with Varisolve 1.0% demonstrated a statistically significant improvement in symptoms compared with subjects who received placebo (p < 0.0001). The co-secondary endpoints were also reached: improvement in appearance in the Varisolve arm compared with the placebo arm, as measured by both a patient-reported outcome and by a blinded independent panel review of photographs (p < 0.0001 and p < 0.0001, respectively). In VANISH 2, results were similar, with both primary and secondary endpoints reached.