Background and importance Pharmacological therapy for hypercholesterolaemia aims to reduce circulating low density lipoprotein (LDL) concentrations. A new therapy for patients who fail to achieve the desired targets consists of monoclonal antibodies that selectively and irreversibly bind proprotein convertase subtilisin/kexin type 9 (PCSK9) to prevent its binding to the LDL receptor (LDL-R)/LDL complex on the surface of hepatocytes. Increased LDL-R liver levels result in serum reduction of LDL cholesterol.
Aim and objectives The aim of this study was to define the effectiveness of two inhibitors, alirocumab and evolocumab, using changes in lipid parameters and ratios of patients during therapy. Furthermore, an additional goal was calculation of the 10 year cardiovascular risk according to the Framingham Heart Study algorithm that includes age, sex, systolic pressure, smoking, diabetes, antihypertensive therapy, LDL, high density lipoprotein (HDL) and total cholesterol.
Material and methods The study was conducted from May 2017 to September 2018. The 120 enrolled patients had at least a 6 month re-evaluation. Data were extracted from the registers compiled and updated on the AIFA (Italian Drugs Agency) web monitoring platform. Patient data such as age, sex, smoking, diabetes, hypertension and adherence were extracted and processed using Microsoft Access. In the same way, lipid ratios were calculated, and factors and percentage cardiovascular risk at 10 years were calculated using the Framingham Heart Study algorithm.
Results Average age was 63 years and 68% were men. About 60% of 120 patients had arterial hypertension and 22% had diabetes mellitus. Concomitant therapy with statins (evolocumab–alirocumab) was present in 42% and 56% of patients, respectively, while intolerance was found in 52% and 47% of cases, respectively. Adherence to therapy was 100%. LDL and triglyceride concentrations decreased (LDL −60%) while HDL values remained constant over the study period. The percentage risk of a 10 year cardiovascular event was reduced from about 35% to 15% in 6 months and remained stable at 12 months.
Conclusion and relevance The results confirmed a reduction in LDL cholesterol levels. These drugs represent treatment for patients subject to therapeutic failure. Alirocumab and evolocumab are innovative drugs with high costs. Their use should be limited to patient categories who have no real feedback with conventional drugs used in hypercholesterolaemia.
References and/or acknowledgements No conflict of interest.
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