EFFECTS OF DEFIBROTIDE IN PATIENTS WITH CHRONIC DEEP INSUFFICIENCY. THE PROVEDIS STUDY

Salvatore Novo, Gian Franco Gensini, D'Addato, Coccheri, Andreozzi

    Risultato della ricerca: Article

    14 Citazioni (Scopus)

    Abstract

    Aim. In the present study the effect of defibrotide, an antithrombotic and profibrinolytic agent, was investigated in patients with chronic venous insufficiency (CVI) due to deep vein obstruction and/or reflux (chronic deep vein insufficiency, CDVI).Methods. The study was a multicenter, randomized, double blind placebo controlled trial in which only patients with CDVI confirmed by ultrasound were enrolled. All patients were treated with adequate elastic compression and randomized to receive either oral defibrotide (800 mg/die) or matching placebo for 1 year. Patients with active or previous leg ulcer were excluded.Results. A total of 288 patients were randomized and 159 completed the study. At baseline ultrasound investigation, obstructive changes were found in 2/3 of all patients thus ascertaining a post-thrombotic syndrome (PTS). The primary endpoint, ankle circumpherence, was significantly reduced under defibrotide from day 120 throughout 360. Scores for pain and edema were improved. The number of episodes of superficial thrombophlebitis and deep vein thrombosis was significantly lower under defibrotide (n=2) than under placebo (n=10). The majority of these events occurred in the subset of patients with documented PTS.Conclusion. Treatment with defibrotide in addition to elastic compression in patients with objectively assessed CDVI, mostly due to PTS, resulted in clinical benefits and prevented thrombotic complications harmful to the limb conditions
    Lingua originaleEnglish
    pagine (da-a)100-107
    Numero di pagine8
    RivistaINTERNATIONAL ANGIOLOGY
    Volume23
    Stato di pubblicazionePublished - 2004

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    Veins
    Placebos
    Venous Insufficiency
    Thrombophlebitis
    Leg Ulcer
    Fibrinolytic Agents
    defibrotide
    Ankle
    Venous Thrombosis
    Edema
    Extremities
    Pain
    Therapeutics

    All Science Journal Classification (ASJC) codes

    • Cardiology and Cardiovascular Medicine

    Cita questo

    EFFECTS OF DEFIBROTIDE IN PATIENTS WITH CHRONIC DEEP INSUFFICIENCY. THE PROVEDIS STUDY. / Novo, Salvatore; Gensini, Gian Franco; D'Addato; Coccheri; Andreozzi.

    In: INTERNATIONAL ANGIOLOGY, Vol. 23, 2004, pag. 100-107.

    Risultato della ricerca: Article

    Novo, S, Gensini, GF, D'Addato, Coccheri & Andreozzi 2004, 'EFFECTS OF DEFIBROTIDE IN PATIENTS WITH CHRONIC DEEP INSUFFICIENCY. THE PROVEDIS STUDY', INTERNATIONAL ANGIOLOGY, vol. 23, pagg. 100-107.
    Novo, Salvatore ; Gensini, Gian Franco ; D'Addato ; Coccheri ; Andreozzi. / EFFECTS OF DEFIBROTIDE IN PATIENTS WITH CHRONIC DEEP INSUFFICIENCY. THE PROVEDIS STUDY. In: INTERNATIONAL ANGIOLOGY. 2004 ; Vol. 23. pagg. 100-107.
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    abstract = "Aim. In the present study the effect of defibrotide, an antithrombotic and profibrinolytic agent, was investigated in patients with chronic venous insufficiency (CVI) due to deep vein obstruction and/or reflux (chronic deep vein insufficiency, CDVI).Methods. The study was a multicenter, randomized, double blind placebo controlled trial in which only patients with CDVI confirmed by ultrasound were enrolled. All patients were treated with adequate elastic compression and randomized to receive either oral defibrotide (800 mg/die) or matching placebo for 1 year. Patients with active or previous leg ulcer were excluded.Results. A total of 288 patients were randomized and 159 completed the study. At baseline ultrasound investigation, obstructive changes were found in 2/3 of all patients thus ascertaining a post-thrombotic syndrome (PTS). The primary endpoint, ankle circumpherence, was significantly reduced under defibrotide from day 120 throughout 360. Scores for pain and edema were improved. The number of episodes of superficial thrombophlebitis and deep vein thrombosis was significantly lower under defibrotide (n=2) than under placebo (n=10). The majority of these events occurred in the subset of patients with documented PTS.Conclusion. Treatment with defibrotide in addition to elastic compression in patients with objectively assessed CDVI, mostly due to PTS, resulted in clinical benefits and prevented thrombotic complications harmful to the limb conditions",
    author = "Salvatore Novo and Gensini, {Gian Franco} and D'Addato and Coccheri and Andreozzi",
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    AU - Gensini, Gian Franco

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    AU - Coccheri, null

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    N2 - Aim. In the present study the effect of defibrotide, an antithrombotic and profibrinolytic agent, was investigated in patients with chronic venous insufficiency (CVI) due to deep vein obstruction and/or reflux (chronic deep vein insufficiency, CDVI).Methods. The study was a multicenter, randomized, double blind placebo controlled trial in which only patients with CDVI confirmed by ultrasound were enrolled. All patients were treated with adequate elastic compression and randomized to receive either oral defibrotide (800 mg/die) or matching placebo for 1 year. Patients with active or previous leg ulcer were excluded.Results. A total of 288 patients were randomized and 159 completed the study. At baseline ultrasound investigation, obstructive changes were found in 2/3 of all patients thus ascertaining a post-thrombotic syndrome (PTS). The primary endpoint, ankle circumpherence, was significantly reduced under defibrotide from day 120 throughout 360. Scores for pain and edema were improved. The number of episodes of superficial thrombophlebitis and deep vein thrombosis was significantly lower under defibrotide (n=2) than under placebo (n=10). The majority of these events occurred in the subset of patients with documented PTS.Conclusion. Treatment with defibrotide in addition to elastic compression in patients with objectively assessed CDVI, mostly due to PTS, resulted in clinical benefits and prevented thrombotic complications harmful to the limb conditions

    AB - Aim. In the present study the effect of defibrotide, an antithrombotic and profibrinolytic agent, was investigated in patients with chronic venous insufficiency (CVI) due to deep vein obstruction and/or reflux (chronic deep vein insufficiency, CDVI).Methods. The study was a multicenter, randomized, double blind placebo controlled trial in which only patients with CDVI confirmed by ultrasound were enrolled. All patients were treated with adequate elastic compression and randomized to receive either oral defibrotide (800 mg/die) or matching placebo for 1 year. Patients with active or previous leg ulcer were excluded.Results. A total of 288 patients were randomized and 159 completed the study. At baseline ultrasound investigation, obstructive changes were found in 2/3 of all patients thus ascertaining a post-thrombotic syndrome (PTS). The primary endpoint, ankle circumpherence, was significantly reduced under defibrotide from day 120 throughout 360. Scores for pain and edema were improved. The number of episodes of superficial thrombophlebitis and deep vein thrombosis was significantly lower under defibrotide (n=2) than under placebo (n=10). The majority of these events occurred in the subset of patients with documented PTS.Conclusion. Treatment with defibrotide in addition to elastic compression in patients with objectively assessed CDVI, mostly due to PTS, resulted in clinical benefits and prevented thrombotic complications harmful to the limb conditions

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