Efficacy and safety of alirocumab 300mg in real-world clinical practice: preliminary data from the ALINET Registry

Abstract Background/Introduction Alirocumab, a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), is widely used for lowering low-density lipoprotein cholesterol (LDL-C). Alirocumab 300mg, administered as a single injection every four weeks, has been recently introduced in clinical practice. Phase III clinical trials have demonstrated that alirocumab 300 mg provides sustained lipid-lowering effects and is well tolerated, making it a valuable option in cardiovascular (CV) risk management. However, data regarding the use of alirocumab 300mg in a real-world setting are limited. Purpose ALINET is an Italian multicenter prospective phase 4 registry, designed to assess efficacy, safety, adherence and persistence of alirocumab 300mg treatment. Aim of this analysis was to evaluate percentage change in LDL-C from baseline and the proportion of patients achieving LDL-C targets according to CV risk class. Methods The ALINET registry enrolled patients receiving alirocumab 300mg according to standard clinical practice. Clinical and demographic characteristics, concomitant therapies, blood chemistry, were recorded at the time of first prescription and at subsequent follow-ups. Results This preliminary analysis included 80 patients enrolled in the ALINET registry (66.3% male, mean age 62 years). Alirocumab 300mg was mainly prescribed in ambulatory setting (66.3%), during hospitalization for acute coronary syndrome (ACS, 26.2%), or during hospitalization for other causes (7.5%). Of these patients, 46.3% had hypertension, 8.8% had type 2 diabetes mellitus, 2.5% had familial hypercholesterolemia, and 28.8% had a previous ACS. Most patients (88.8%) were at very high CV risk. At the time of this analysis LDL-C values at first lipid control were available only for 28 patients. Among these, 53.6% were on statin and ezetimibe combination, 28.6% were on ezetimibe alone, and 17.9% were not receiving lipid-lowering therapy in addition to alirocumab 300mg. In this population, baseline median LDL-C was 128 mg/dL [IQR 74; 154] and decreased to 32 mg/dL [IQR 22; 51] at first lipid control at a median time of 123 days from first alirocumab 300mg prescription (p<0.001). Median LDL-C percentage reduction was 70 [IQR 56; 83]. Among 28 patients with first lipid control, 23 (82%) achieved LDL-C target according to CV risk class (p<0.001). Persistence with treatment in these patients was 100%. Conclusions This preliminary analysis from the ALINET registry demonstrates that alirocumab 300 mg provides significant LDL-C reduction, with 82% of patients achieving their LDL-C target based on CV risk classification. Further studies with larger sample sizes and longer follow-up are warranted to confirm these results and assess long-term outcomes.