Treatment of Truncal Incompetence and Varicose Veins with a Single Administration of a New Polidocanol Endovenous Microfoam Preparation Improves Symptoms and Appearance

Eur J Vasc Endovasc Surg. 2015 Dec;50(6):784-93. doi: 10.1016/j.ejvs.2015.06.111. Epub 2015 Sep 16.

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.

Trial registration: ClinicalTrials.gov NCT01072877.

Keywords: Polidocanol endovenous microfoam; Polidocanol injectable foam; Varicose veins.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Female
  • Humans
  • Injections, Intravenous
  • Male
  • Middle Aged
  • Patient Satisfaction
  • Polidocanol
  • Polyethylene Glycols / administration & dosage*
  • Polyethylene Glycols / adverse effects
  • Quality of Life
  • Saphenous Vein* / diagnostic imaging
  • Sclerosing Solutions / administration & dosage*
  • Sclerosing Solutions / adverse effects
  • Sclerotherapy / adverse effects
  • Sclerotherapy / methods*
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Ultrasonography, Doppler, Duplex
  • United States
  • Varicose Veins / diagnosis
  • Varicose Veins / physiopathology
  • Varicose Veins / therapy*
  • Venous Insufficiency / diagnosis
  • Venous Insufficiency / physiopathology
  • Venous Insufficiency / therapy*

Substances

  • Sclerosing Solutions
  • Polidocanol
  • Polyethylene Glycols

Associated data

  • ClinicalTrials.gov/NCT01072877