CLEVIPREX
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    CLEVIPREX

    Clevidipino

    Hipertensión arterial perioperatoria

    Cleviprex es un antihipertensivo intravenoso indicado para el control rápido de la presión arterial  en el entorno perioperatorio. Clevidipino es un antagonista dihidropiridínico de los canales de calcio (ACA) de tipo L. Se caracteriza por un efecto de inicio y desaparición rápido, que permite reducir y mantener la presión arterial en un rango deseado de forma precisa y modulada.1

    Este medicamento está sujeto a seguimiento adicional, es prioritaria la notificación de sospechas de reacciones adversas asociadas a este medicamento.

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    Información adicional

    Indicaciones

    Cleviprex es una emulsión lipídica que contiene 0,5 mg/ml de butirato de Clevidipino, para la administración intravenosa. Cleviprex está indicado para la reducción rápida de la presión arterial en el entorno perioperatorio.1

    Posología

    Adultos/Pacientes de edad avanzada
    El clevidipino está indicado para el uso intravenoso. Ajuste la dosis del medicamento para alcanzar la reducción deseada de la presión arterial. Personalice la dosis en función de la presión arterial a obtener y la respuesta del paciente. Se deben monitorizar la presión arterial y frecuencia cardiaca de forma continua durante la perfusión, y posteriormente hasta que se estabilicen las constantes vitales. Los pacientes que reciben perfusiones prolongadas de clevidipino y que no han cambiado a otras terapias antihipertensoras, deben ser monitorizados durante al menos 8 horas tras finalizar la perfusión por la posibilidad de presentar una hipertensión de rebote.
    Dosis inicial : Inicie la perfusión intravenosa de clevidipino a 4 ml/h (2 mg/h); se puede duplicar la dosis cada 90 segundos. Continúe ajustando la dosis hasta alcanzar el intervalo diana deseado.
    Dosis de mantenimiento : La mayoría de los pacientes alcanzan la respuesta terapéutica deseada con dosis de 8 – 12 ml/h (4-6 mg/h).
    Dosis máxima : En los estudios clínicos, la mayoría de los pacientes recibieron tratamiento con dosis de 32 ml/h (16 mg/h) o inferiores. La dosis máxima recomendada es de 64 ml/h (32 mg/h). La experiencia clínica es limitada con dosis superiores a 64 ml/h (32 mg/h). Se recomienda no administrar más de 1000 ml de clevidipino para perfusión en el periodo inicial de 24 horas debido a la carga de lípidos asociada. La experiencia clínica es limitada con perfusiones de clevidipino que duren más de 72 horas con cualquier dosis.
    Transición a un antihipertensivo oral: Se debe suspender el clevidipino o reducir gradualmente la dosis mientras se establece la terapia oral adecuada. Al instaurar un antihipertensivo oral, se debe tener en cuenta el lapso de tiempo hasta que el antihipertensivo oral surta efecto. Continuar la monitorización de la presión arterial hasta alcanzar el efecto deseado. La suspensión de Cleviprex produce una reducción de los efectos antihipertensores en un plazo de 5 a 15 minutos.1

    Forma de administración

    Antes de usar Cleviprex, se debe invertir suavemente el vial para garantizar la uniformidad de la emulsión. No requiere dilución previa ni ajuste de dosis según peso, función renal o hepática. La administración puede realizarse con bomba de infusión volumétrica o de jeringa, a través de una vía central o periférica. El vial de Cleviprex es de un solo uso.1

    Seguridad

    Cleviprex está contraindicado en pacientes con hipersensibilidad al principio activo, a la soja, al aceite de soja refinado, a los productos de soja, al cacahuete, a los huevos o los productos derivados del huevo o a alguno de los excipientes. Clevidipino no se debe utilizar en pacientes con defectos en el metabolismo de los lípidos como hiperlipidemia patológica, nefrosis lipoide o pancreatitis aguda si se acompaña de hiperlipidemia.
    Toda la información sobre seguridad del producto puede ser consultada en la Ficha Técnica.1

    Presentaciones

    Cleviprex 0,5mg/ml emulsión inyectable 10 viales 50 ml (CN: 693620.7)

     

     

     

    Referencias

    Agencia Española de Medicamentos y Productos Sanitarios. Centro de Información online de Medicamentos de la AEMPS. Ficha técnica CLEVIPREX® [sede web]. [Actualizado 2015; acceso noviembre 2015].

    Clevidipine effectively and rapidly controls blood pressure preoperatively in cardiac surgery patients: the results of the randomized, placebo-controlled efficacy study of clevidipine assessing its preoperative antihypertensive effect in cardiac surgery-1

    BACKGROUND: Clevidipine is an ultrashort-acting, third-generation IV dihydropyridine calcium channel blocker that exerts rapid and titratable arterial blood pressure reduction, with fast termination of effect due to metabolism by blood and tissue esterases. As an arterial-selective vasodilator, clevidipine reduces peripheral vascular resistance directly, without dilating the venous capacitance bed. In this randomized, double-blind, placebo-controlled multicenter trial we evaluated the efficacy and tolerability of clevidipine in treating preoperative hypertension.

    METHODS: One-hundred-fifty-two patients scheduled for cardiac surgery with current or recent hypertension were randomized to receive clevidipine or placebo preoperatively. One-hundred-five patients met postrandomization entrance criteria (systolic blood pressure [SBP] ≥160 mm Hg after inserting an arterial catheter) for reduction by ≥15% from baseline in SBP. The patients thus received infusions of clevidipine (0.4–8.0 μg · kg−1 · min−1) or 20% lipid emulsion (placebo) for at least 30 min. Treatment failure was defined as failure to reduce SBP by ≥15% from baseline or discontinuance of drug for any reason.

    RESULTS: Patients treated with clevidipine demonstrated a 92.5% rate of treatment success and a significantly lower rate of treatment failure (7.5%, 4 of 53) than patients receiving placebo (82.7%, 43 of 52; P < 0.0001). Clevidipine achieved target blood pressures (SBP reduced by ≥15%) at a median of 6.0 min (95% confidence interval 6–8 min). A modest increase in heart rate from baseline occurred during clevidipine administration. Adverse events for each treatment group were similar.

    CONCLUSIONS: Clevidipine was effective in rapidly decreasing blood pressure preoperatively to targeted blood pressure levels and was well tolerated in patients scheduled for cardiac surgery.

    Levy JH, Mancao MY, Gitter R, Kereiakes DJ, Grigore AM, Aronson S, Newman MF.
    Anesth Analg;105(4):918-25.
    10/2007
    Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial

    BACKGROUND: Acute postoperative hypertension is a well-known complication of cardiac surgery and is associated with postoperative morbidity. Clevidipine, an ultrashort-acting, third-generation dihydropyridine calcium channel blocker, exerts vascular-selective, arterial-specific vasodilation to decrease arterial blood pressure without negatively impacting cardiac function. In this double-blind, placebo-controlled trial, we examined the efficacy and safety of clevidipine in treating postoperative hypertension in cardiac surgery patients.

    METHODS: Two hundred six patients undergoing cardiac surgery were randomized preoperatively. Of these, 110 met postrandomization inclusion criteria for the study [systolic blood pressure (SBP) ≥140 mm Hg within 4 h of admission to a postoperative setting, and clinically assessed as needing SBP reduction by ≥15% from baseline]. Patients received an infusion of either clevidipine (0.4–8.0 μg kg−1 min−1) or 20% lipid emulsion (placebo) for 30 min to a maximum of 1 h unless treatment failure occurred sooner. The primary end point was the incidence of treatment failure, defined as the inability to decrease SBP by ≥15% from baseline, or the discontinuation of study treatment for any reason within the 30-min period after study drug initiation.

    RESULTS: Clevidipine-treated patients had a significantly lower incidence of treatment failure than placebo patients [8.2% (5 of 61) vs 79.6% (39 of 49), P < 0.0001]. Treatment success was achieved in 91.8% of clevidipine-treated patients. Median time to target SBP with clevidipine was 5.3 min (95% confidence interval, 4–7 min). No clinically significant increase in heart rate from baseline was observed. Adverse event rates were similar for both treatment groups.

    CONCLUSIONS: Clevidipine is effective and safe in the rapid treatment of acute postoperative hypertension after cardiac surgery.

    Singla N, Warltier DC, Gandhi SD, Lumb PD, Sladen RN, Aronson S, Newman MF, Corwin HL; ESCAPE-2 Study Group.
    Anesth Analg.;107(1):59-67.
    01/2008
    Clevidipine, an intravenous dihydropyridine calcium channel blocker, is safe and effective for the treatment of patients with acute severe hypertension

    STUDY OBJECTIVE: We assess the safety and efficacy of intravenous clevidipine for treating patients with acute severe increase in blood pressure by using prespecified, non-weight-based titration dosing, with continuous maintenance infusion for 18 hours or longer.

    METHODS: Prospective, open-label, single-arm evaluation of patients aged 18 years or older and presenting in the emergency department or ICU with severe hypertension (systolic blood pressure >180 mm Hg and/or diastolic blood pressure >115 mm Hg) and treated with clevidipine to achieve a predetermined, patient-specific systolic blood pressure target range. Clevidipine was initiated at 2 mg per hour and titrated as needed in doubling increments every 3 minutes to a maximum of 32 mg per hour, during 30 minutes, and then continued for a total duration of 18 to 96 hours.

    RESULTS: Study patients commonly presented with both acute hypertension and end-organ injury; 81% (102/126) had demonstrable end-organ injury at baseline. Within 30 minutes of starting clevidipine, 88.9% (104/117) of patients achieved target range. Median time to target range was 10.9 minutes. No concomitant intravenous antihypertensives were needed in 92.3% (108/117) of patients receiving 18 hours or more of clevidipine infusion. Clevidipine was well tolerated with successful transition to oral antihypertensive therapy after infusion to a defined blood pressure target in 91.3% (115/126) of patients.

    CONCLUSION: Clevidipine, dosed in a non-weight-based manner, was safe and effective in a cohort of patients with severe hypertension at a starting dose of 2 mg per hour, followed by simple titration during 18 hours or more of continuous infusion. Patients were effectively managed via simple blood pressure cuff monitoring throughout.

    Pollack CV, Varon J, Garrison NA, Ebrahimi R, Dunbar L, Peacock WF 4th.
    Ann Emerg Med;53:329-38.
    01/2009
    The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients

    BACKGROUND: Acute hypertension during cardiac surgery can be difficult to manage and may adversely affect patient outcomes. Clevidipine is a novel, rapidly acting dihydropyridine L-type calcium channel blocker with an ultrashort half-life that decreases arterial blood pressure (BP). The Evaluation of CLevidipine in the Perioperative Treatment of Hypertension Assessing Safety Events trial (ECLIPSE) was performed to compare the safety and efficacy of clevidipine (CLV) with nitroglycerin (NTG), sodium nitroprusside (SNP), and nicardipine (NIC) in the treatment of perioperative acute hypertension in patients undergoing cardiac surgery.

    METHODS: We analyzed data from three prospective, randomized, open-label, parallel comparison studies of CLV to NTG or SNP perioperatively, or NIC postoperatively in patients undergoing cardiac surgery at 61 medical centers. Of the 1964 patients enrolled, 1512 met postrandomization inclusion criteria of requiring acute treatment of hypertension based on clinical criteria. The patients were randomized 1:1 for each of the three parallel comparator treatment groups. The primary outcome was the incidence of death, myocardial infarction, stroke or renal dysfunction at 30 days. Adequacy and precision of BP control was evaluated and is reported as a secondary outcome.

    RESULTS: There was no difference in the incidence of myocardial infarction, stroke or renal dysfunction for CLV-treated patients compared with the other treatment groups. There was no difference in mortality rates between the CLV, NTG or NIC groups. Mortality was significantly higher, though, for SNP-treated patients compared with CLV-treated patients (P= 0.04). CLV was more effective compared with NTG (P = 0.0006) or SNP (P = 0.003) in maintaining BP within the prespecified BP range. CLV was equivalent to NIC in keeping patients within a prespecified BP range; however, when BP range was narrowed, CLV was associated with fewer BP excursions beyond these BP limits compared with NIC.

    CONCLUSIONS: CLV is a safe and effective treatment for acute hypertension in patients undergoing cardiac surgery.

    Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, Kereiakes DJ, Newman MF.
    Anesth Analg.;107(4):1110-21.
    01/2008

    SEDAR

    Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor.

    Cleviprex

    Instrucciones de uso, contraindicaciones, posología y forma de administración.

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    2017

    XXXIII Congreso Nacional de la SEDAR, 4-6 Mayo 2017

    SEDAR. Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor.

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    Última modificación: 06/02/2018