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4CPS-022 PCSK9 inhibitors: evaluation of effectiveness in our centre in relation to the official clinical endpoints

Background and importance Cardiovascular diseases are the main cause of mortality in developed countries. One of the main cardiovascular risk factors is high levels of low density lipoprotein cholesterol (LDL-c). However, for those categories of patients with severe hypercholesterolaemia, or patients who are intolerant to statins, there are limited therapeutic options. Currently, evolocumab and alirocumab, cholesterol lowering monoclonal antibodies, are used. Clinical studies show that their use, in addition to statins, is associated with a reduction in LDL-c of up to 50–60% compared with basal levels. Aim and objectives The aim of the study was to review the use of PCSK9 inhibitors in our centre evaluating effectiveness in relation to official clinical endpoints. Material and methods A retrospective cohort study was conducted in patients who began using proprotein convertase subtilsin-kexin type 9 (PCSK9) inhibitors between August 2017 and September 2019. The data were retrieved from the web based register of the Italian Medicines Agency, patient electronic medical records and the internal dispensation programme. All patients being treated with evolocumab and alirocumab were analysed from the first prescription to the first revaluation. The main variables collected were: gender, age, indication, LDL value before and after the first evaluation of treatment, and high density lipoprotein (HDL) and triglycerides values before and after the first evaluation. The collected data were analysed and evaluated through the SPSS programme. Results A total of 52 patients were analysed, 29 patients treated with evolucumab and 23 patients with alirocumab, of whom 62.00% were women. Medium age was 60.30±14.20 years and 50.00% had a family type disease, 15.00% a non-family type and 35.00% mixed dyslipidaemia. For patients treated with evolocumab, the mean LDL value before treatment was 189.90±57.62, HDL 51.63±19.79 and triglycerides 186.16±86.76. After treatment, the LDL value was 98.54±48.49 (Δ=91.35±36.96, ρ<0.000) a decrease of 51.89%. For patients treated with alirocumab, the median LDL value before treatment was 196.06±45.38, HDL 48.50±12.94 and triglycerides 164.28±71.19. After treatment, LDL was 84.00±39.53 (Δ=112.06±38.90, ρ<0.000), a decrease of 51.13%. Conclusion and relevance The data confirm the results of clinical studies: treatment with evolocumab and alirocumab achieve the primary endpoint of lowering LDL. A statistically significant reduction in HDL and triglycerides was not observed. References and/or acknowledgements No conflict of interest.