Significance of Symptoms

Significance of symptoms: Why patients choose treatment

  • Studies show that the general public largely perceives varicose veins as a cosmetic rather than a medical issue—and that nonspecialist physicians consider varicose vein symptoms to be minor 9-10
  • Research also shows that patients elect varicose vein treatment solely or primarily for symptom relief, and only secondarily for cosmetic reasons 4-6


Varithena® studies focused on symptom relief

In the clinical trials for Varithena®, the primary endpoint was improvement in varicose vein symptoms.*
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. 
  • To measure symptom relief, the VVSymQ® instrument was developed and thoroughly tested by BTG for reliability, sensitivity, and content validity, in accordance with FDA guidelines for the development of patient-reported outcomes (PRO) tools.8 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 5 most relevant varicose vein symptoms (HASTI™ Symptoms):
  • Heaviness
    Achiness
    Swelling
    Throbbing
    Itching
Clinical trial efficacy measures also included improvement in varicose vein appearance and physiological response to treatment.

*Primary endpoint: Improvement in symptoms as measured by change in VVSymQ® Score from baseline to Week 8.
Learn how your eligible
patients may fill their
Varithena® prescription
for $0 with the
Varithena® Co-pay 
 Assistance Program.

Contact your Territory
Sales Manager for more information.
Varithena Solutions Center™
1-855-971-VEIN (8346)
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INDICATIONS

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®.

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