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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