Efectividad y seguridad del tratamiento con iPCSK9 en vida realexperiencia de tres hospitales asturianos

  1. R. Rodríguez Escobedo 1
  2. S. González Martínez 2
  3. L. Díaz Naya 3
  4. L. Suárez Gutiérrez 4
  5. J.L. Fernández Morera 1
  6. M. Riestra Fernández 3
  7. C. Martínez Faedo 1
  8. F. Villazón González 1
  9. E.L. Menéndez Torre 1
  1. 1 Hospital Universitario Central de Asturias, Oviedo, Asturias, España
  2. 2 Hospital Vital Álvarez Buylla, Mieres, Asturias, España
  3. 3 Hospital Universitario de Cabueñes, Gijón, Asturias, España
  4. 4 Hospital Universitario San Agustín, Avilés, Asturias, España
Mostrar afiliaciones +
Revista:
Semergen: revista española de medicina de familia

ISSN: 1138-3593

Año de publicación: 2021

Número: 6

Páginas: 369-375

Tipo: Artículo

DOI: 10.1016/J.SEMERG.2021.03.008 DIALNET GOOGLE SCHOLAR

Otras publicaciones en: Semergen: revista española de medicina de familia

Resumen

Introducción El uso de inhibidores de la proproteína convertasa subtilisina/kexina tipo 9 (iPCSK9) es una opción de tratamiento para los pacientes con hipercolesterolemia familiar (HF) o en prevención secundaria que no alcanzan el objetivo de cLDL con otras medidas terapéuticas. El objetivo del estudio es valorar la efectividad y la seguridad de estos fármacos en vida real. Material y métodos Estudio descriptivo retrospectivo multicéntrico. Se han revisado todos los pacientes en tratamiento con iPCSK9 en tres centros hospitalarios de Asturias desde el inicio de su uso en 2016. Se han recogido los cambios en el perfil lipídico así como los efectos adversos relacionados con el uso de iPCSK9. Resultados Se obtuvieron datos de 98 pacientes, 75 de ellos afectos de HF y 23 no afectos. A los dos meses del inicio del tratamiento con iPCSK9 se aprecia una reducción del cLDL del 61% en pacientes afectos de HF y del 52% en no afectos. Esta reducción, estadísticamente significativa, se mantuvo estable durante el seguimiento. Se observó una disminución significativa del colesterol total, sin cambios significativos en cHDL y triglicéridos. El 96% de los pacientes no presentaron efectos adversos. Conclusiones Los iPCSK9 son fármacos seguros que consiguen reducciones marcadas en los valores de cLDL de una manera rápida y mantenida en el tiempo. Por lo tanto, suponen una alternativa para el control del cLDL en aquellos pacientes en los que no se alcanza el cLDL objetivo con otras medidas terapéuticas.

Referencias bibliográficas

  • Cholesterol Treatment Trialists’ (CTT) Collaboration Efficacy and safety of more intensive lowering of LDL cholesterol: A meta-analysis of data from 170,000 participants in 26 randomised trials Lancet., 376 (2010), pp. 1670-1681, 10.1016/S0140-6736(10)61350-5 Google Scholar
  • F. Mach, C. Baigent, A.L. Catapano, K.C. Koskinas, M. Casula, L. Badimon, et al. 2019 ESC/EAS guidelines for the management of dyslipidaemias: Lipid modification to reduce cardiovascular risk Eur Heart J., 41 (2020), pp. 111-188, 10.1093/eurheartj/ehz455 View PDFCrossRefView Record in ScopusGoogle Scholar
  • American Diabetes Association 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes—2020 Diabetes Care., 43 (2020), pp. S111-S134, 10.2337/dc20-S010 Google Scholar
  • M.R. Law Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: Systematic review and meta-analysis BMJ., 326 (2003), pp. 1423-1430, 10.1136/bmj.326.7404.1423 View PDFView Record in ScopusGoogle Scholar
  • T.A. Jacobson NLA Task Force on Statin Safety — 2014 update J Clin Lipidol., 8 (2014), pp. S1-S4, 10.1016/j.jacl.2014.03.003 ArticleDownload PDFView Record in ScopusGoogle Scholar
  • C.P. Cannon, M.A. Blazing, R.P. Giugliano, A. McCagg, J.A. White, P. Theroux, et al. Ezetimibe added to statin therapy after acute coronary syndromes N Engl J Med., 372 (2015), pp. 2387-2397, 10.1056/nejmoa1410489 View PDFCrossRefView Record in ScopusGoogle Scholar
  • E.M. Roth, M.H. Davidson PCSK9 inhibitors: Mechanism of action, efficacy, and safety Rev Cardiovasc Med., 19 (2018), pp. S31-S46 View Record in ScopusGoogle Scholar
  • B.A. Warden, S. Fazio, M.D. Shapiro The PCSK9 revolution: Current status, controversies, and future directions Trends Cardiovasc Med., 30 (2020), pp. 179-185, 10.1016/j.tcm.2019.05.007 ArticleDownload PDFView Record in ScopusGoogle Scholar
  • Schmidt, L.S. Pearce, J.T. Wilkins, J.P. Overington, A.D. Hingorani, J.P. Casas PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease Cochrane Database of Systematic Reviews. (2017), 10.1002/14651858.CD011748.pub2 Google Scholar
  • J.G. Robinson, M. Farnier, M. Krempf, J. Bergeron, G. Luc, M. Averna, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events N Engl J Med., 372 (2015), pp. 1489-1499, 10.1056/NEJMoa1501031 View PDFCrossRefView Record in ScopusGoogle Scholar
  • M.S. Sabatine, R.P. Giugliano, A.C. Keech, N. Honarpour, S.D. Wiviott, S.A. Murphy, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease N Engl J Med., 376 (2017), pp. 1713-1722, 10.1056/nejmoa1615664 View PDFCrossRefView Record in ScopusGoogle Scholar
  • Dictamen de la Comisión de Uso Racional de los Medicamentos y Productos Sanitarios (CURMP) sobre la inclusión en la guía farmacoterapéutica del SESPA de Alirocumab y Evolocumab para el tratamiento de la hipercolesterolemia. Dictamen 09/2017. Disponible en: https://www.astursalud.es/documents/31867/36150/INHIBIDORES+PCSK9+DICTAMEN+N%C3%82%C2%BA+9+2017.pdf/2a5d9aca-aff8-f72f-b539-53e501c73f61 Google Scholar
  • R.D. Santos, E.A. Stein, G.K. Hovingh, D.J. Blom, H. Soran, G.F. Watts, et al. Long-term evolocumab in patients with familial hypercholesterolemia J Am Coll Cardiol., 75 (2020), pp. 565-574, 10.1016/j.jacc.2019.12.020 ArticleDownload PDFView Record in ScopusGoogle Scholar
  • F.J. Raal, E.A. Stein, R. Dufour, T. Turner, F. Civeira, L. Burgess, et al. PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): A randomised, double-blind, placebo-controlled trial Lancet., 385 (2015), pp. 331-340, 10.1016/S0140-6736(14)61399-4 ArticleDownload PDFView Record in ScopusGoogle Scholar
  • H.N. Ginsberg, D.J. Rader, F.J. Raal, J.R. Guyton, M.T. Baccara-Dinet, C. Lorenzato, et al. Efficacy and safety of alirocumab in patients with heterozygous familial hypercholesterolemia and LDL-C of 160 mg/dl or higher Cardiovasc Drugs Ther., 30 (2016), pp. 473-483, 10.1007/s10557-016-6685-y View PDFCrossRefView Record in ScopusGoogle Scholar
  • L.S. Rallidis, I. Skoumas, E.N. Liberopoulos, C. Vlachopoulos, E. Kiouri, I. Koutagiar, et al. PCSK9 inhibitors in clinical practice: Novel directions and new experiences Hellenic J Cardiol., 61 (2020), pp. 241-245, 10.1016/j.hjc.2019.10.003 ArticleDownload PDFView Record in ScopusGoogle Scholar
  • R.P. Giugliano, N.R. Desai, P. Kohli, W.J. Rogers, R. Somaratne, F. Huang, et al. Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia (LAPLACE-TIMI 57): A randomised, placebo-controlled, dose-ranging, phase 2 study Lancet., 380 (2012), pp. 2007-2017, 10.1016/S0140-6736(12)61770-X ArticleDownload PDFView Record in ScopusGoogle Scholar
  • J.G. Robinson, B.S. Nedergaard, W.J. Rogers, J. Fialkow, J.M. Neutel, D. Ramstad, et al. Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: The LAPLACE-2 randomized clinical trial JAMA., 311 (2014), p. 1870, 10.1001/jama.2014.4030 View PDFCrossRefView Record in ScopusGoogle Scholar
  • M.J. Koren, M.S. Sabatine, R.P. Giugliano, G. Langslet, S.D. Wiviott, H. Kassahun, et al. Long-term low-density lipoprotein cholesterol–lowering efficacy, persistence, and safety of evolocumab in treatment of hypercholesterolemia: Results up to 4 years from the open-label OSLER-1 extension study JAMA Cardiol., 2 (2017), p. 598, 10.1001/jamacardio.2017.0747 View PDFCrossRefView Record in ScopusGoogle Scholar
  • M.J. Koren, M.S. Sabatine, R.P. Giugliano, G. Langslet, S.D. Wiviott, A. Ruzza, et al. Long-term efficacy and safety of evolocumab in patients with hypercholesterolemia J Am Coll Cardiol., 74 (2019), pp. 2132-2146, 10.1016/j.jacc.2008.1024 ArticleDownload PDFView Record in ScopusGoogle Scholar
  • D.J. Blom, T. Hala, M. Bolognese, M.J. Lillestol, P.D. Toth, L. Burgess, et al. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia N Engl J Med., 370 (2014), pp. 1809-1819, 10.1056/NEJMoa1316222 View Record in ScopusGoogle Scholar
  • E.A. Stein, R.P. Giugliano, M.J. Koren, F.J. Raal, E.M. Roth, R. Weiss, et al. Efficacy and safety of evolocumab (AMG 145), a fully human monoclonal antibody to PCSK9, in hyperlipidaemic patients on various background lipid therapies: Pooled analysis of 1359 patients in four phase 2 trials Eur Heart J., 35 (2014), pp. 2249-2259, 10.1093/eurheartj/ehu085 View PDFCrossRefView Record in ScopusGoogle Scholar
  • G.G. Schwartz, P.G. Steg, M. Szarek, D.L. Bhatt, V.A. Bittner, R. Diaz, et al. Alirocumab and cardiovascular outcomes after acute coronary syndrome N Engl J Med., 379 (2018), pp. 2097-2107, 10.1056/NEJMoa1801174 View PDFCrossRefView Record in ScopusGoogle Scholar
  • D.J. Blom, T. Hala, M. Bolognese, M.J. Lillestol, P.D. Toth, L. Burgess, et al. A 52-week placebo-controlled trial of evolocumab in hyperlipidemia N Engl J Med., 370 (2014), pp. 1809-1819, 10.1056/NEJMoa1316222 View Record in ScopusGoogle Scholar
  • D. Gaudet, J.L. López-Sendón, M. Averna, G. Bigot, M. Banach, A. Letierce, et al. Safety and efficacy of alirocumab in a real-life setting: The ODYSSEY APPRISE study Eur J Prev Cardiol. (2020), 10.1093/eurjpc/zwaa097 Google Scholar
  • P. Guedeney, S. Sorrentino, G. Giustino, C. Chapelle, S. Laporte, B.E. Claessen, et al. Indirect comparison of the efficacy and safety of alirocumab and evolocumab: A systematic review and network meta-analysis Eur Heart J Cardiovasc Pharmacother. (2020), 10.1093/ehjcvp/pvaa024 Google Scholar
  • D.J. Blom, C.S. Djedjos, M.L. Monsalvo, I. Bridges, S.M. Wasserman, R. Scott, et al. Effects of evolocumab on vitamin E and steroid hormone levels: Results from the 52-week, phase 3, double-blind, randomized, placebo-controlled DESCARTES study Circ Res., 117 (2015), pp. 731-741, 10.1161/CIRCRESAHA.115.307071 View PDFView Record in ScopusGoogle Scholar
  • B. Gencer, F. Mach, J. Guo, K. Im, A. Ruzza, H. Wang, et al. Cognition after lowering LDL-cholesterol with evolocumab J Am Coll Cardiol., 75 (2020), pp. 2283-2293, 10.1016/j.jacc.2003.039 ArticleDownload PDFView Record in ScopusGoogle Scholar
  • N.R. Desai, R.P. Giugliano, J. Zhou, P. Kohli, R. Somaratne, E. Hoffman, et al. AMG 145, a monoclonal antibody against PCSK9, facilitates achievement of national cholesterol education program-adult treatment panel III low-density lipoprotein cholesterol goals among high-risk patients: An analysis from the LAPLACE-TIMI 57 trial (LDL-C assessment with PCSK9 monoclonal antibody inhibition combined with statin therapy-thrombolysis in myocardial infarction 57) J Am Coll Cardiol., 63 (2014), pp. 430-433, 10.1016/j.jacc.2013.09.048 ArticleDownload PDFView Record in ScopusGoogle Scholar
  • J.F. Ascaso, F. Civeira, C. Guijarro, J. López Miranda, L. Masana, J.M. Mostaza, et al. Indicaciones de los inhibidores de PCSK9 en la práctica clínica. Recomendaciones de la Sociedad Española de Arteriosclerosis (SEA), 2019 Clin Investig Arterioscler., 31 (2019), pp. 128-139, 10.1016/j.arteri.2019.04.002 ArticleDownload PDFView Record in ScopusGoogle Scholar
Fuente de los datos: Dialnet