OBJECTIVE: This multicenter, parallel group study was designed to determine if a single administration of  <=15  mL of pharmaceutical-grade @entity5324 endovenous microfoam (PEM, now approved in the United States as Varithena [ @entity5324 injectable foam], BTG International Ltd.) could alleviate symptoms and improve appearance of varicose veins in a typical population of @entity1 with moderate to very severe symptoms of superficial @entity1211 and visible varicosities of the great saphenous vein (GSV) system. METHODS: The primary endpoint was @entity1 -reported venous symptom improvement measured by change from baseline to Week 8 in 7-day average VVSymQ score. Co-secondary endpoints measured improvement in appearance of visible varicose veins from baseline to Week 8, as measured by the Independent Photography Review-Visible @entity6312 (IPR-V(3)) and @entity1 Self-assessment of Visible @entity6312 (PA-V(3)) scores. @entity1 were randomized to five groups: PEM 0.125% (control), 0.5%, 1%, 2%, or placebo. Adverse events (AEs) were recorded at each study visit. Tertiary endpoints measured duplex ultrasound response, changes in venous clinical severity score, and the modified @entity4096 Epidemiological and Economic Study-Quality of Life/Symptoms. RESULTS: At Week 8, VVSymQ scores for the pooled PEM group (0.5%  +  1%  +  2%; p  <  .0001) and individual dose concentrations (p  <  .001) were significantly superior to placebo. Mean changes from baseline to Week 8 in IPR-V3 and PA-V(3) scores were significantly greater for pooled PEM than for placebo (p  <  .0001). Most AEs were mild and resolved without sequelae. No @entity1151 were reported. CONCLUSIONS: This study demonstrated that a single administration of up to 15  mL of PEM is a safe, effective, and convenient treatment for the symptoms of superficial @entity1211 and the appearance of visible varicosities of the GSV system. Doses of 0.5%, 1%, and 2% PEM appear to have an acceptable risk-benefit ratio.

Treatment of Truncal Incompetence and @entity6312 with a Single Administration of a New XXXX Endovenous Microfoam Preparation Improves Symptoms and Appearance.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient', 'Patient'] @entity1151 :: ('MESH:D011655', 'Disease') :: ['pulmonary emboli'] @entity6312 :: ('MESH:D014648', 'Disease') :: ['Varicose Veins'] @entity4096 :: ('MESH:D014689', 'Disease') :: ['Venous Insufficiency'] @entity1211 :: ('MESH:D054556', 'Disease') :: ['venous incompetence'] @entity5324 :: ('MESH:C008976', 'Chemical') :: ['polidocanol']
@entity5324 :: (MESH:C008976,Chemical) :: ['Polidocanol']
