Newer, more stringent LDL targets in 90% of patients receiving lerodalcibep vs only 16% of those on placebo, despite concurrent treatment with a statin or statin plus ezetimibe.
The findings from the LIBerate-HR trial were presented at the American College of Cardiology (ACC) Scientific Session 2024.
The first goal is to get at least a 50% reduction in LDL-C, said Klug. The ACC, the American Heart Association, and the European Society of Cardiology recommended LDL-C of no more than 55 mg/dL as a goal for patients with CVD or who are at a very high risk for myocardial infarction or stroke and no more than 70 mg/dL for high-risk patients.
LIBerate-HR included 922 patients with CVD or at a high or very high risk for myocardial infarction or stroke at 66 centers in 11 countries. Over half (52%) fell into the at-risk category.
The mean age of participants was 64.5 years, 77% were White, and, notably, about 45% were women. Some 84% were taking a statin, 16.6% ezetimibe, a quarter had diabetes, and 10% had the more severe inherited familial hypercholesterolemia (FH).
Patients were randomly assigned to receive monthly 300-mg (1.2-mL) subcutaneous injections of lerodalcibep (n = 615) or placebo (n = 307) for 52 weeks.
The mean LDL-C at baseline was 116.9 mg/dL in the placebo group and 116.3 mg/dL in the treatment group.
The co-primary efficacy endpoints were the percent change from baseline in LDL-C at week 52 and the mean of weeks 50 and 52 (average of the peak and trough dose).
Compared with placebo, lerodalcibep reduced LDL-C by 56.19% at week 52 (P < .0001) and by 62.69% at mean week 50/52 (P < .0001). The absolute decreases were 60.6 mg/dL at week 52 and 74.5 mg/dL for mean week 50/52.
https://www.medscape.com/viewarticle/novel-pcsk9-inhibitor-reduced-ldl-50-2024a10007hi?src=
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