Noticias

Noticias

  • Título: BTG announces Varithena™ data demonstrating continued improvement at one year at the American Venous Forum Annual Meeting
  • Fecha: 21-02-2014

  • LONDON, Feb. 21, 2014 /PRNewswire/ -- Today at the 26th Annual Meeting of the American Venous Forum in New Orleans, LA, Dr. Kenneth Todd, an American College of Phlebology Committee Member from the Southeast Vein and Laser Center and a Principal Investigator for VANISH-2, presented one-year data from the VANISH-2 clinical trial, one of the two pivotal trials for Varithena™ (polidocanol injectable foam). Varithena™, which was developed by the specialist healthcare company BTG, received US approval from the FDA in November 2013 for the treatment of varicose veins caused by saphenofemoral junction (SFJ) incompetence. Commercial launch in the US is planned in the second quarter of this year.

    One-year results from VANISH-2, a study in which patients with symptomatic and visible varicose veins caused by saphenofemoral junction (SFJ) incompetence were treated with Varithena™, indicate that treatment with Varithena™ led to clinically meaningful and ongoing improvements in symptoms, as measured by the VVSymQ® score.

    The VVSymQ® electronic daily diary is the first and only patient-reported outcomes instrument that measures the burden of varicose vein symptoms developed in accordance with FDA guidelines. The VVSymQ® score measures the five most relevant symptoms to patients: heaviness, achiness, swelling, throbbing, and itching. VVSymQ® scores range from 0 to 25, where 0 represents no symptoms and 25 represents all 5 symptoms experienced all of the time.

    At baseline, 12% of patients treated with Varithena™ 1% reported a VVSymQ® score of 3 or less, whereas 84% of patients reported a VVSymQ® score of 3 or less at Year 1. The mean improvement in VVSymQ® score relative to baseline was 4.7 points at Week 8 and 6.2 points at Year 1.

    Continued improvement at Year 1 was also shown in:

    • Appearance, as measured by a blinded independent panel review of photographs (IPR-V3) and a patient-reported outcome instrument (PA-V3),
    • Disease severity, as measured by the Venous Clinical Severity Score (VCSS), and
    • Varicose vein-related quality of life, as measured by the Venous Insufficiency Epidemiological and Economic Study­−Quality of Life (VEINES-QOL) score.

    Serious adverse events reported in the long-term follow-up period were typical of those that would be expected of the patient population studied and were unrelated to treatment.

    'The one-year data from VANISH-2 are important because they show that clinically meaningful improvements in symptoms and appearance are sustained one year after treatment,' said Dr. Kenneth Todd, MD, 'On-going improvements as shown in the VANISH-2 analysis support the recent FDA approval of Varithena™, which offers a new treatment option for patients with varicose veins.'



  • Fuente: endovascular.es