Real-World Efficacy and Safety of Inclisiran: A Single-Country, Multicenter, Observational Study (CHOLINET Registry)

Randomized trials1 showed that inclisiran effectively and safely reduces low-density lipoprotein cholesterol (LDL-C). Real-world studies reported a median LDL-C reduction (35.5%-38%), with higher reductions (42.2%2-45%3) in patients on statins. Recently, VICTORION-INITIATE4 (A Randomized, Multicenter, Open-label Trial Comparing the Effectiveness of an “Inclisiran First” Implementation Strategy to Usual Care on LDL Cholesterol [LDL-C] in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C [$70 mg/dL] Despite Receiving Maximally Tolerated Statin Therapy) reported significant 53% LDL-C reduction in patients treated with inclisiran vs usual care, underscoring the inertia of traditional approaches. Thus, to address the need for additional real-world data on LDL-C–lowering effects of inclisiran, we designed the CHOLINET (CHOLesterol Italian inclisiran NETwork; NCT06287177) registry, the largest single-country, real-world data set. [...]