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| Turkish Society of Cardiology Young Cardiologists Bulletin Year: 7 Number: 1 / 2024 |
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Name of the Study: Efficacy and Safety of Lerodalcibep in Patients at Very High and High Risk for Cardiovascular Disease - LIBerate-HR Published in Congress: ACC 2024 Link: www.acc.org/clinical-trials/2024/04/05/04/34/liberate-hr Full text has not been published yet. Description:The goal of the trial was to evaluate lerodalcibep compared with placebo among patients with increased risk of cardiovascular disease (CVD). Lerodalcibep blocks pro-protein convertase subtilisin/kexin type 9 (PCSK9) binding to low-density lipoprotein (LDL)-receptors, thus preventing receptor degradation, which enhances LDL-C clearance and lowering of LDL-C levels. Study Design:The study was designed as a randomized, double-blind, placebo-controlled trial. Patients with established or at high risk for CVD were randomized to lerodalcibep 300 mg dose in 1.2 mL subcutaneous injection (n = 615) vs. placebo (n = 307). The study included 922 patients. The follow-up duration was 52 weeks, with a mean patient age of 65. Female patients accounted for 47%, and 45% had diabetes mellitus. Patients at established or high risk for CVD, over 18 years of age, and on stable statin therapy were included. patients Average LDL cholesterol level was 117 mg/dL. Results :The primary outcome, change in LDL-C at 52 weeks, was -56.3% in the lerodalcibep group vs. -0.14% in the placebo group (p < 0.001). Secondary outcomes of the study revealed significant findings. A notably higher percentage of patients achieved a ?50% reduction in LDL-C with lerodalcibep compared to placebo, with rates of 94% and 19%, respectively. Additionally, the incidence of ?1 adverse event leading to study drug withdrawal was slightly lower with lerodalcibep (4.2%) compared to placebo (4.6%). Furthermore, lerodalcibep demonstrated substantial reductions in apolipoprotein B and lipoprotein(a) levels at 52 weeks compared to placebo, with changes of -43% and -33%, respectively. Conclusions :These findings highlight the potential efficacy of lerodalcibep in improving lipid profiles and tolerability compared to placebo in patients with established or high risk for cardiovascular disease Interpretations :Among patients with established or at high risk for CVD on stable statin therapy, lerodalcibep improves lipid control. Lerodalcibep vs. placebo was associated with a significant reduction in LDL-C and a greater proportion of patients achieving ?50% reduction in LDL-C.
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