Protein Convertase Subtilisin/Kexin Type 9 Monoclonal Antibodies (PCSK9mab) in Clinical Practice at Secondary Care -...

Background and Aims Protein convertase subtilisin/Kexin type 9 monoclonal antibodies (PCSK9mab) are a novel addition to the therapeutic options for managing hyperlipidemia. Various guidelines have advocated the addition of these agents if the target low-density lipoprotein-cholesterol ( LDL-C) is not achieved by maximum lipid-lowering therapy. They have shown a robust and consistent reduction in LDL-C in clinical trials. However, the translation of these results in a real-world setting is limited and confined mainly to tertiary lipid centers. This service evaluation aimed to assess their efficacy in a real-world outpatient setting of secondary care centers. Methods Data was collected retrospectively from four hospitals in the North-West of England. Patients were required to attend a lipid clinic for follow-up investigations to continue with the prescription of PCSK9mab. Results A total of 175 patients were identified. Efficacy outcomes were measured in 169 patients. 6 discontinued the agent within 3 months of initiation and were excluded from the efficacy outcomes. 19.5% (n=33) had confirmed familial hypercholesterolemia. 61% (n=103) of the patients were intolerant to statins. 53.2% (n=90) of the patients have been prescribed Alirocumab. Mean LDL-C reduction was 50.6% at 6-month which was sustained at 48.9% at 12 months. There was no difference in % reduction of LDL-C between Alirocumab and Evolocumab. LDL-C reduction was more significant in patients who were on concomitant statins. 9.1% of patients experienced side effects, and 5.1% discontinued the PCSK9mab during treatment. Conclusion The efficacy of lipid reduction and the side effect profile of PCSK9mab from these secondary care services are similar to randomized clinical trials and real-world observational studies from tertiary lipid centers.