title: Treatment of Truncal Incompetence and Varicose Veins with a Single Administration of a New Polidocanol Endovenous Microfoam Preparation Improves Symptoms and Appearance.
abstract: OBJECTIVE
  This multicenter, parallel group study was designed to determine if a single administration of ≤15 mL of pharmaceutical-grade polidocanol endovenous microfoam (PEM, now approved in the United States as Varithena [polidocanol injectable foam], BTG International Ltd.) could alleviate symptoms and improve appearance of varicose veins in a typical population of patients with moderate to very severe symptoms of superficial venous incompetence and visible varicosities of the great saphenous vein (GSV) system.
  
  
  METHODS
  The primary endpoint was patient-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 Varicose Veins (IPR-V(3)) and Patient Self-assessment of Visible Varicose Veins (PA-V(3)) scores. Patients 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 Venous Insufficiency 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 pulmonary emboli 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 venous incompetence 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.
authors.affiliation: Vein Clinics of America, Oakbrook, IL, USA.
authors.forename: J T
authors.initials: JT
authors.lastname: King
authors.affiliation: The Vein Clinic, San Diego, CA, USA.
authors.forename: M
authors.initials: M
authors.lastname: O'Byrne
authors.affiliation: Venous Institute of Buffalo, North Tonawanda, NY, USA.
authors.forename: M
authors.initials: M
authors.lastname: Vasquez
authors.affiliation: BTG International Ltd, Philadelphia, PA, USA. Electronic address: david.wright@btgplc.com.
authors.forename: D
authors.initials: D
authors.lastname: Wright
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D012501:Saphenous Vein / Q000000981:diagnostic imaging; D012597:Sclerosing Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D015911:Sclerotherapy / Q000009:adverse effects / Q000379:methods*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014481:United States; D014648:Varicose Veins / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D014689:Venous Insufficiency / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*
chemical_list: D012597:Sclerosing Solutions; D000077423:Polidocanol; D011092:Polyethylene Glycols
keywords: Polidocanol endovenous microfoam; Polidocanol injectable foam; Varicose veins