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4CPS-031 The primary efficacy endpoint for alirocumab, reductions in low-density lipoprotein cholesterol
  1. J Polo García,
  2. J Preciado Goldaracena,
  3. N Larrea Goñi,
  4. R de la Riva Bohigas,
  5. JA Illodo Becerra,
  6. A Rodriguez Esquiroz,
  7. M Coma Punset,
  8. P Aldave Cobos,
  9. B Larrayoz Sola,
  10. M Sarobe Carricas
  1. Complejo Hospitalario de Navarra, Farmacia, Pamplona, Spain


Background Cholesterol levels in many patients with familial hypercholesterolaemia (HeFH) or dyslipidaemia are poorly controlled despite dietary changes and maximally tolerated statin therapy. Alirocumab, a monoclonal antibody that targets a specific protein, PCSK9, provides another option for patients who have not been able to lower their low-density lipoprotein cholesterol (LDL-C).

Purpose To analyse the use and outcomes of alirocumab treatment in patients with HeFH, or dyslipidaemia with high/very high cardiovascular (CDV) risk, as an adjunct to diet in a tertiary-level hospital.

Material and methods Retrospective, observational study of patients who started alirocumab treatment from September 2016 to September 2018. Variables: sex, age, diagnosis, dose modification, and serum levels of LDL-C. Inadequate control was defined as LDL-C greater than or equal to 70 mg/dL after 12 week of treatment.

Results Seventy-four patients, 64% men, mean age 58.6 years. All of them were high/very high CDV risk (stable or unstable coronary artery disease, ischaemic stroke, transient ischaemic attack or peripheral arterial disease). Eighty per cent presented baseline LDL-C levels higher than 150 mg/dL. Forty (54%) patients reached the targeted range for LDL-C. Thirty-four (46%) patients reached LDL-C levels>70. All of them started with 75 mg every 14 days. Only nine patients (27%) have increased the dose of praluent to 150 mg/14 days in the week 12.

Conclusion Dosage adjustments according to LDL-C levels should be followed closely to achieve better outcomes. The dose should be increased to 150 mg every 2 weeks at week 12 if LDL-C is greater or equal to 70 mg/dL at week 8. An adequate organisation and coordination between the different implicated medical services would be desirable, as the dates for monitoring LDL-C and the optimal monitoring interval are already established.

References and/or acknowledgements Alirocumab: EPAR – Summary for the public. EMA

No conflict of interest.

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