Inclisiran in a real-world single-center registry of patients with very high atherosclerotic cardiovascular risk

Abstract

Background

A mean relative 50 % reduction of LDL cholesterol (LDLc) levels was observed in randomized studies in patients treated with inclisiran, a small-interfering-RNA therapeutic agent that reduces hepatic synthesis of PCSK9. Less is known on real world and every-day practice patients.

Methods

Fifty consecutive patients with or at risk of atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) and treated with inclisiran according to Italian indications were enrolled in an observational study. LDLc levels were followed up.

Results

26 patients had an acute coronary syndrome (ACS), 11 FH; 46 % were on high-intensity statin therapy, 68 % on combination therapy statin/ezetimibe.

Mean LDLc level of the study population was 118 ± 12 mg/dl at baseline, 80 ± 18 mg/dl after 3 months, and 70 ± 15 mg/dl after 6 months (ANOVA p < 0.001). The use of inclisiran was associated with significantly reduced LDLc levels of 21 % at 1 month and 44 % at 6 months.

LDLc reduction in patients with ACS was statistically significant and comparable with chronic CS. Patients receiving a background combination therapy (statin/ezetimibe) showed a greater reduction in circulating LDLc levels than patients using inclisiran alone. No significant side effects or treatment drop out were observed during follow up. Rates of subjects with LDLc levels below 70 mg/dl (Italian Drug Agency target) increased from 0 % at baseline to 56 % at 6 months (p < 0.001).

Conclusions

In a real-world population 3–6 months of therapy with inclisiran provide consistent and effective reduction in LDLc levels without significant adverse side-effects.