ETOXISCLEROL
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    ETOXISCLEROL

    Lauromacrogol 400

    Flebología

    Etoxisclerol® solución inyectable (lauromacrogol 400) es un agente esclerosante indicado para el tratamiento de venas varicosas y telangiectasias que se administra por vía endovenosa a nivel local, tanto en forma líquida como en microespuma.1 Etoxisclerol® solución inyectable 30 mg/ml también está indicado en el tratamiento esclerosante de hemorroides.1 La Guía Europea de Escleroterapia en Trastornos Venosos Crónicos incluye lauromacrogol 400 como fármaco esclerosante de primera línea.2

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    Información adicional

    Indicaciones

    Tratamiento esclerosante de venas varicosas y telangiectasias (se requieren diferentes concentraciones de Etoxisclerol solución inyectable, dependiendo del tamaño y severidad de las varices a tratar). En caso de duda se debe de elegir la dosis inferior.1

    Posología

    Se necesitan diferentes concentraciones de Etoxisclerol en función del tamaño de las venas varicosas a tratar. Si para el tratamiento se han determinado diferentes concentraciones, tiene que considerarse el diámetro de la vena y la situación individual del paciente. Debe escogerse la concentración más baja posible.1

    * venas perforantes o venas varicosas tributarias: hasta 2 ml por punción.
    ¥ vena safena menor: hasta 4 ml por punción / vena safena mayor: hasta 6 ml por punción.
    § En general: 2-8 ml por sesión.

    Forma de administración

    Todas las inyecciones deben administrarse por vía intravenosa; la posición de la aguja debe ser comprobada (por ejemplo, mediante una aspiración de sangre). Independientemente del modo de punción venosa (en un paciente de pie con sólo una cánula o en un paciente sentado con una jeringa lista para la inyección), las inyecciones se llevarán a cabo normalmente en una pierna en posición horizontal. Se recomiendan jeringas desechables de movimiento suave para la escleroterapia, así como agujas de diferentes diámetros, en función de la indicación. Para telangiectasias se usan agujas muy finas (ej. agujas de insulina). La punción se realiza tangencialmente y la inyección se administra lentamente. El esclerosante debe ser administrado por vía intravenosa en pequeñas alícuotas en múltiples puntos de la vena a tratar. En el tratamiento de las venas perforantes, se recomienda no inyectar directamente en la vena diana. El objetivo es lograr la destrucción óptima de la pared del vaso con la menor 3 concentración de esclerosante necesaria para un resultado clínico. Si la concentración es demasiado alta se puede producir necrosis u otras secuelas adversas. Dependiendo del grado y la extensión de las venas varicosas, se pueden requerir varias sesiones de tratamiento. Se deberá mantener una técnica estrictamente aséptica durante el manejo de Etoxisclerol.1

    Presentaciones

    Etoxisclerol 5mg/ml solución inyectable (CN: 688259.7)

    Etoxisclerol 20mg/ml solución inyectable (CN: 688242.9)

    Etoxisclerol 30mg/ml solución inyectable (CN: 688234.4)

     

    Referencias

    1 Agencia Española de Medicamentos y Productos Sanitarios. Centro de Información online de Medicamentos de la AEMPS. Ficha técnica ETOXICLEROL®  [sede web]. [Actualizado 2015; acceso noviembre 2015].
    2 Rabe E, Breu F, Cavezzi A, Smith PC, Frullini A, Gillet J, et al. European guidelines for sclerotherapy in chronic venous disorders. Phlebology. 2014 May 3;29(6):338-354.

    EASYFOAM KIT

    Fabricante: Chemische Fabrik Kreussler & Co. GmbH.

    Etoxisclerol Profesionales

     

    Etoxisclerol Pacientes

    Sclerotherapy of telangiectases and reticular veins: a double-blind, randomized, comparative clinical trial of polidocanol, sodium tetradecyl sulphate and isotonic saline (EASI study)

    OBJECTIVES: To assess the efficacy and safety of polidocanol (POL) in comparison to sodium tetradecyl sulphate (STS) and isotonic saline (placebo) for sclerotherapy of telangiectases or reticular veins by means of standardized digital imaging system, independent medical observers and detailed monitoring.

    METHODS: Of 316 randomized patients, 160 with telangiectases were randomly assigned to 0.5% POL, 1% STS or placebo, and 156 with reticular veins received 1% POL, 1% STS or placebo. Veins selected for injection were clearly visible telangiectases or reticular veins in a predefined treatment area (10x10 cm). Exact retrieval of the location was guaranteed by a newly established digital imaging system. Images were taken before first injection and 12 and 26 weeks after the last of three possible injection visits, and evaluated by the investigator and two blinded independent observers. The detailed safety monitoring included ultrasound screening for 'silent' deep vein thrombosis, electrocardiograms and clinical laboratory tests.

    RESULTS: POL demonstrated a statistically significant superiority versus placebo (P < 0.0001) for the primary criterion 'improvement of veins'. Significantly more patients were satisfied with POL at 12 or 26 weeks (84%, 88%) compared to STS (64%, 63%; P < 0.0001) and placebo (14%, 11%; P < 0.0001). POL was safe and well tolerated apart from expected local symptoms at the injection site.

    CONCLUSION: Sclerotherapy of telangiectases and reticular veins with detergent-like sclerosants such as polidocanol (POL) or sodium tetradecyl sulphate (STS) is a well-established technique. However, evidence from clinical trials comparing these substances with a non-active solution is sparse and does not live up to expectations of modern clinical trial concepts necessary for authorisation purposes. The presented multicentre EASI study fulfils these requirements and clearly demonstrates that Sclerotherapy of C1 veins with POL is highly effective and deserves the adjunct 'gold standard'.

    Rabe E, Schliephake D, Otto J, Breu FX, Pannier F.
    Phlebology. 2010 Jun;25(3):124-31.
    01/2010
    Efficacy and safety of great saphenous vein sclerotherapy using standardised polidocanol foam (ESAF): a randomised controlled multicentre clinical trial

    AIM: To assess the safety and efficacy of sclerotherapy of the great saphenous vein (GSV) comparing standardised polidocanol foam to liquid polidocanol in a randomised controlled trial (RCT).

    METHODS: A multicentre randomised controlled clinical trial was carried out in which saphenous trunks were treated by sclerotherapy. 106 patients with primary varicose veins due to an incompetent GSV were treated with either standardised 3% polidocanol foam or 3% liquid polidocanol. The primary efficacy criterion was elimination of reflux (<0.5 sec) measured 3 cm below the sapheno-femoral junction (SFJ) by duplex ultrasonography 3 months after the last injection.

    RESULTS: A significantly greater number of patients were successfully treated by foam sclerotherapy resulting in 69% elimination of reflux compared to 27% patients treated with liquid sclerosant. The secondary endpoints of vein occlusion, reflux time, refilling time and patient satisfaction also improved significantly more in the foam group. The mean number of treatment sessions was 1.3 in the foam group compared to 1.6 in the liquid group. Differences between study centres occurred with a mean of 96% reflux elimination in 6 centres versus 39% in 4 other centres. Centres with a high response rate injected a higher mean volume (4.3 vs. 3.6 ml) in the first session in a vein with a smaller diameter (7.5 mm vs. 8.4 mm). No difference in adverse drug reactions was observed between treatment groups.

    CONCLUSIONS: Standardised 3% polidocanol foam is more efficient and equally safe compared to 3% liquid polidocanol for treatment of GSV. In comparison to other studies a relatively small volume was injected into relatively large veins.

    Rabe E, Otto J, Schliephake D, Pannier F.
    Eur J Vasc Endovasc Surg. 2008 Feb;35(2):238-45.
    01/2008
    The French polidocanol study on long-term side effects: a survey covering 3,357 patient years

    BACKGROUND: AIMS Short- and mid-term side effects of sclerotherapy, in particular with polidocanol (lauromacrogol 400), have been previously described in our registry of 12,173 sessions. The objective of this follow-up registry was to evaluate the long-term incidence of adverse events with polidocanol.

    METHODS: The physicians involved in the initial French registry were contacted and asked to partake in the follow-up survey. Initially included patients were controlled at the latest possible date to determine whether a complication had occurred after the end of the initial survey.

    RESULTS: Data on 1,605 patients included in the French registry were reviewed with a maximum follow-up of 60 months, covering 3,357 patient years. Five (0.4%) adverse events were observed in patients treated with liquid polidocanol and 46 (1.1%) in patients treated with polidocanol foam. The most frequent side effects were visual disturbances (n=14), and the most severe were muscular vein thrombosis (n=8). The onset of side effects was mostly observed directly after sclerotherapy or in the 6 months after (84% in the first year). One deep vein thrombosis recurrence occurred in a patient with heterozygote Factor V Leiden after stopping anticoagulant treatment (foam sclerotherapy).

    CONCLUSIONS: Foam sclerotherapy is a recognized reference method in the treatment of varicose veins of all types. This study demonstrates that polidocanol is a safe sclerosing agent in the short and long term.

    Guex JJ, Schliephake DE, Otto J, Mako S, Allaert FA.
    Dermatol Surg. 2010 Jun;36 Suppl 2:993-1003.
    01/2010

    SEACV

    Sociedad Española de Angiología y Cirugía Vascular.

    Etoxisclerol Internacional

    Etoxisclerol® solución inyectable 30 mg/ml. Una opción de tratamiento en hemorroides de grado I, II.

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    2017

    VII Curso de Escleroterapia en Fleboestética y Patología Venosa del CEFyL

    CEFyL. Capítulo Español de Flebología y Linfología. SEACV. Sociedad Española de Angiología y Cirugía Vascular.

    Madrid
     

    10th Compact Sclerotherapy Training Course, 20 Mayo 2017

    German Society of Phlebology & Sclerotherapy working group of the German Society of Phlebology.

    Munich, Alemania
     

    XXXII Congreso SEME, 16-18 Febrero 2017

    SEME. Sociedad Española de Medicina Estética.

    Málaga
     

    2016

    9th Compact Sclerotherapy Training Course, 5 Noviembre 2016

    German Society of Phlebology & Sclerotherapy working group of the German Society of Phlebology.

    Munich, Alemania
     

    VI Curso de Escleroterapia en Fleboestética y Patología Venosa del CEFyL, 4 Noviembre 2016

    CEFyL. Capítulo Español de Flebología y Linfología. SEACV. Sociedad Española de Angiología y Cirugía Vascular.

    Madrid
     

    XXXI Congreso SEME, 18-20 Febrero 2016

    SEME. Sociedad Española de Medicina Estética.

    Málaga

    Noticias

    Última modificación: 16/02/2017