Retrospective Observational Analysis in a Cohort Patients in Treatment with Alirocumab and Evolocumab: Focus on C-LDL Values

Salvatore Coppolino

Abstract


Hypercholesterolemia is the main risk factor for cardiovascular disease. Statins are the drugs of first choice, but many patients fail to reach the recommended levels of LDL cholesterol, or are intolerant. The PCSK9 inhibitor drugs (Alirocumab and Evolocumab) are anti-PCSK9 antibodies: represent a new pharmacological approach, and have been approved as an adjunct to Statins or in intolerant patients. The aim of the work was to carry out a retrospective analysis of a cohort of patients treated with anti-PCSK9 antibodies. The AIFA Therapeutic Plans were received by the Pharmacy from 01/01/2021 to 06/30/2023 by extrapolating data such as: sex, age, prescribed PCSK-9, adverse reactions, LDL cholesterol values before treatment and at the first re-evaluation. Out of 329 patients on treatment, 215 (65.3%) were treated with Evolocumab, 114 (34.7%) with Alirocumab. The 329 patients analyzed , have an average age of 64 years (minimum 30 - maximum 87). Our analysis has highlighted that in post-treatment patients the percentage change in LDL cholesterol values compared to baseline is equal to 59.8% in line with what was observed in the ODISSEY and FOURIER studies. PCSK9 inhibitors are state-of-the-art therapies and are well tolerated and effective in the management of the statin-intolerant patient, or as an adjunct to existing lipid-lowering therapies. Furthermore, statins increase serum PCSK9 levels; therefore, the best effect of these inhibitors is seen in combination with them


Keywords


Key words: hypercholesterolemia, Low Density Lipoprotein, PCSK-9, Hydroxymethylglutaryl-CoA Reductase Inhibitors, pharmacovigilance.

Full Text:

PDF

References


Pierno, S., Familial hypercholesterolemia. What it is and how to treat it. Sif Magazine 22 ottobre 2020

Available at: https://www.sifweb.org/sif-magazine/articolo/ipercolesterolemia-familiare-cos-e-e-come-trattarla-2020-10-22 Accessed on 09-27-2023.

Conte, C., Rousseau, V., Vert, C., Montastruc, F., Montastruc, JL., Durrieu, G., et al. Adverse drug reactions of statins in children and adolescents: a descriptive analysis from VigiBase, the WHO global database of individual case safety reports. Fundamental & Clinical Pharmacology. 2020; 34 (4): 518-520. https://doi.org/10.1111/fcp.12542

Jose, J., Statins and its hepatic effects: newer data, implications, and changing recommendations. J Pharm Bioallied Sci. 2016;8(1):23–8. https://doi.org/10.4103/0975-7406.171699

Update n. 15 of “PTORS” Available at:

https://pti.regione.sicilia.it/portal/page/portal/PIR_PORTALE/PIR_LaStrutturaRegionale/PIR_AssessoratoSalute/PIR_DipPianificazioneStrategica/PIR_Infoedocumenti/PIR_Avvisiecomunicazioni/PIR_AttivitaAreeeServizi/PIR_Servizio7/PIR_PTORS/Aggiornamento%20n.%2015%20del%20PTORS.pdf Accessed on 09-27-2023

Update n. 15 of “PTORS” Available at:

https://pti.regione.sicilia.it/portal/page/portal/PIR_PORTALE/PIR_LaStrutturaRegionale/PIR_AssessoratoSalute/PIR_DipPianificazioneStrategica/PIR_Infoedocumenti/PIR_Avvisiecomunicazioni/PIR_AttivitaAreeeServizi/PIR_Servizio7/PIR_PTORS/Aggiornamento%20%20n.19%20del%20PTORS.pdf Accessed on 09-27-2023

Determina AIFA n. 1771/2019 published in the Official Gazette n. 291 of 12-12-2019. Available at:

https://www.aifa.gov.it/documents/20142/961234/Determina_1771-2019_Repatha.pdf Accessed on 09-27-2023

Determine AIFA n. 434 e 435 of 30/06/2022. Avalaibles at:

https://www.aifa.gov.it/documents/20142/961234/Determina_434-2022_Praluent.pdf Accessed on 09-27-2023 https://www.aifa.gov.it/documents/20142/961234/Determina_435-2022_Repatha.pdf Accessed on 09-27-2023

Sabatine, M.S., Giugliano, R.P., Wiviott S.D., Raal, F.J. Blom, D.J., Robinson, J.et al. Efficacy and safety of Evolocumab in Reducing Lipids and Cardiovascular Events. N Engl J Med 2015; 372:1500-9. https://www.nejm.org/doi/full/10.1056/nejmoa1500858

Robinson, J.G., Farnier, M., Krempf, M., Bergeron, J. Luc, G., Averna, M.et al. Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events. N Engl J Med 2015; 372:1489-99. https://www.nejm.org/doi/full/10.1056/nejmoa1501031

Mach, F., Baigent, C., Catapano, A.L., Koskinas, C.K., Casula, M. Badimon L. et al 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. European Heart Journal (2019) 00, 178. https://dx.doi.org/10.1093/eurheartj/ehz455

Perrone Filardi, P., Paolillo, S., Trimarco, B., Controllo lipidico in pazienti ad elevato rischio cardiovascolare: focus sull’inibizione di PCSK9 Giornale Italiano di Cardiologia 2015;16 (1): 44-51. http://dx.doi.org/10.1714/1776.19250

Cicero, A.F., Tartagni, E., Ertek, S., Safety and tolerability of injectable lipid-lowering drugs: a review of available clinical data. Expert Opinion on Drug Safety 2014; 13: 1023-1030. https://doi.org/10.1517/14740338.2014.932348

Lipinski, M.J., Benedetto, U., Escarcega, R.O., Biondi Zoccai, G., Lhermusier T., Baker, N.C. et al. The impact of proprotein convertase subtilisin-kexin type 9 serine protease inhibitors on lipid levels and outcomes in patients with primary Hypercholesterolaemia: a network metanalysis. European Heart Journal 2016; 37: 536-545. https://doi.org/10.1093/eurheartj/ehv563

Ridker, P.M., Tardif, J.C., Amarenco, P., Duggan, W., Glynn R.J., Jukema, W.J.et al. Lipid-reduction variability and antidrug-antibody formation with bococizumab. The New England Journal of Medicine 2017; 376:1517-1526. https://www.nejm.org/doi/10.1056/NEJMoa1614062?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200www.ncbi.nlm.nih.gov

Deedwania, P., Murphy, S.A., Scheen, A., Bardariene, L., Pineda, A.L., Honarpour, N, et al Efficacy and Safety of PCSK9 Inhibition With Evolocumab in Reducing Cardiovascular Events in Patients With Metabolic Syndrome Receiving Statin Therapy JAMA Cardiol. 2021 Feb; 6(2): 139–147. https://doi.org/10.1001/jamacardio.2020.3151

Schwartz, G.G., Steg, P.G., Bhatt, D.L., Bittner V.A., Diaz R., Goodman S.G. et al. Clinical Efficacy and Safety of Alirocumab After Acute Coronary Syndrome According to Achieved Level of Low-Density Lipoprotein Cholesterol: A Propensity Score-Matched Analysis of the ODYSSEY OUTCOMES Trial. Circulation 2021 Mar 16;143(11):1109-1122. https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.049447




DOI: https://doi.org/10.15416/pcpr.v10i1.51899

Refbacks

  • There are currently no refbacks.


                                                                         
Pharmacology and Clinical Pharmacy Research is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License
 
                                                                      VIEW VISITOR STATS