Clinical Trials of Varithena
Varithena safety and efficacy have been evaluated in 1,333 patients in 12 clinical trials.
Two Multi-Center Blinded Studies
Varithena was evaluated in two randomized, blinded, multi-center clinical trials, with the primary goal of improvement in varicose vein symptoms, supported by our indications. Clinical trial efficacy measures included improvement in both the appearance of varicose veins and physiological response to treatment.
- Data demonstrated efficacy and durability of Varithena treatment in the GSV.
- To measure symptom relief, the VVSymQ® instrument was developed and thoroughly tested for reliability, sensitivity and content validity, in accordance with FDA guidelines for the development of patient-reported outcomes tools.1 It is the first and only varicose vein symptom PRO tool to meet these requirements.
- Using the VVSymQ® electronic daily diary, study patients rated the severity of the five most relevant varicose vein symptoms (HASTI™ symptoms): heaviness, achiness, swelling, throbbing and itching.
Take-Aways from the Studies
Varithena provided clinically meaningful improvement* in symptoms and appearance in patients with incompetent GSV, accessory saphenous veins and visible varicosities of the GSV system. Improvement was measured by a patient global impression of change questionnaire at Week 8.
*Percent of patients who reported their symptoms (or appearance of varicose veins) had “moderately improved” or “much improved” compared with baseline.
- Compared to FDA cleared or approved indications for other varicose vein therapies; CEAP Grade C2-6.
Varithena® (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.
Important Safety Information
The use of Varithena® is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease. Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately.Varithena® can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis. The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis, and deep vein thrombosis.Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease and be trained in the administration of Varithena®.
See Full Prescribing Information for Varithena®