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Inicio Clínica e Investigación en Arteriosclerosis (English Edition) Indications of PCSK9 inhibitors in clinical practice. Recommendations of the Spa...
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Vol. 31. Issue 3.
Pages 128-139 (May - June 2019)
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Vol. 31. Issue 3.
Pages 128-139 (May - June 2019)
Special article
DOI: 10.1016/j.artere.2019.06.001
Open Access
Indications of PCSK9 inhibitors in clinical practice. Recommendations of the Spanish Society of Arteriosclerosis (SEA), 2019
Indicaciones de los inhibidores de PCSK9 en la práctica clínica. Recomendaciones de la Sociedad Española de Arteriosclerosis (SEA), 2019
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Juan Francisco Ascasoa, Fernando Civeirab, Carlos Guijarroc, José López Mirandad, Luis Masanae, José María Mostazaf, Juan Pedro-Botetg, Xavier Pintóh,
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xpinto@bellvitgehospital.cat

Corresponding author.
, Pedro Valdivielsoi
a Hospital Clínico, Universidad de Valencia, CIBERDEM, Valencia, Spain
b Hospital Universitario Miguel Servet, IIS Aragón, CIBERCV, Universidad de Zaragoza, Zaragoza, Spain
c Hospital Universitario Fundación Alcorcón, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain
d Hospital Universitario Reina Sofía, IMIBIC, Universidad de Córdoba, CIBEROBN, Córdoba, Spain
e Hospital Universitario de Reus, Universidad Rovira y Virgili, IISPV, CIBERDEM, Reus, Tarragona, Spain
f Hospital Carlos III, Madrid, Spain
g Hospital del Mar, Universidad Autónoma de Barcelona, Barcelona, Spain
h Hospital Universitario de Bellvitge-Idibell, Universidad de Barcelona, CIBEROBN, Hospitalet de Llobregat, Barcelona, Spain
i Hospital Universitario Virgen de la Victoria, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain
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Tables (6)
Table 1. Current recommendations for the use of PCSK9i according to the main scientific societies of the United States of America, Europe and the Spanish Society of Arteriosclerosis.
Table 2. Risk factors for cardiovascular disease in subjects with familial hypercholesterolaemia on stable treatment with high-potency statins to be calculated for the indication of PCSK9i.
Table 3. Number of patients needed to treat (NNT) with PCSK9i for 5 years (assuming an additional LDL-C reduction of 60%) to prevent a major cardiovascular event (non-fatal AMI, non-fatal stroke or cardiovascular death) in patients already treated with statins, based on the estimated 10-year risk and the LDL-C level.37
Table 4. Real reduction of the absolute risk of major vascular events and the estimated number of patients needed to treat (NNT) at 5 years for the main subgroups of the FOURIER trial.
Table 5. ‘GRADE’ classification of the recommendations.
Table 6. Recommendations and level of evidence for the prescription of PCSK9i in relation to the patient's clinical situation and LDL-C levels.
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Abstract

A group of experts convened by the Spanish Society of Arteriosclerosis (SEA) has been in charge of updating the SEA document on the indications of PCSK9 inhibitors (PCSK9i) in clinical practice that was published in 2016. This update is justified by the fact that the data from clinical trials carried out on a large scale with PCSK9i have shown that in addition to their high potency to lower atherogenic cholesterol, they reduce the risk of atherosclerotic cardiovascular disease, both in patients with stable disease, and with recent disease, and with a high degree of security. This update provides the recommendations and level of evidence for the prescription of iPCSK9 in patients with homozygous and heterozygous familial hypercholesterolemia, with atherosclerotic cardiovascular disease, and in primary prevention in patients with very high cardiovascular risk. These recommendations have been established taking into account the concentration of LDL-C, the clinical situation of the patient, the additional risk factors and the cost-effectiveness of their use.

Keywords:
Proprotein convertase subtilisin kexin 9 inhibitors
Colesterol
Low density lipoprotein
Treatment
Clinical indications
Familial hypercholesterolemia
Cardiovascular disease
Consensus document
Number needed to treat
Resumen

Un grupo de expertos convocado por la Sociedad Española de Arteriosclerosis (SEA) se ha encargado de actualizar el documento de la SEA sobre las indicaciones de los inhibidores de PCSK9 (iPCSK9) en la práctica clínica publicadas en 2016. Esta actualización es necesaria porque en el periodo transcurrido hasta la actualidad se han publicado los resultados de los ensayos clínicos realizados a gran escala con iPCSK9 que demuestran que, además de su alta potencia para disminuir el colesterol aterogénico, disminuyen el riesgo de presentar episodios de enfermedad cardiovascular aterosclerótica en los pacientes con enfermedad tanto estable como reciente, y con un alto grado de seguridad. La presente actualización aporta las recomendaciones y el nivel de evidencia para la prescripción de los iPCSK9 en los pacientes con hipercolesterolemia familiar homo y heterocigota, con enfermedad cardiovascular aterosclerótica y en prevención primaria en los pacientes de muy alto riesgo cardiovascular. Dichas recomendaciones se han establecido teniendo en cuenta la concentración de c-LDL, la situación clínica del paciente, los condicionantes de riesgo adicionales y la relación coste-efectividad de su utilización.

Palabras clave:
Inhibidores de la proproteína convertasa subtilisina kexina 9
Colesterol
Lipoproteínas de baja densidad
Tratamiento
Indicaciones clínicas
Hipercolesterolemia familiar
Enfermedad cardiovascular
Documento de consenso
Número necesario a tratar

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