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Inclisiran offers substantial LDL-C reductions in ASCVD patients

Conference
ESC 2019
Trial
ORION-11

A twice yearly injection with inclisiran – a small-interfering RNA (siRNA) directed against proprotein convertase subtilisin/kexin type 9 [PCSK9] – was able to reduce low-density lipoprotein cholesterol (LDL-C) by 50% in patients with atherosclerotic cardiovascular disease (ASCVD). The treatment was well tolerated with no concerning safety signals.

A total of 1,617 patients, of whom 87.6% had established ASCVD and 12.4% had ASCVD risk-equivalents and elevated LDL-C despite treatment with maximally tolerated statins (with or without ezetimibe), were enrolled in the ORION-11 study. Mean age was 65 years; 28% was female and 35% of the cohort had diabetes. Mean baseline LDL-C was 112 mg/dl, and the vast majority of patients (95%) were treated with statins (95% on a high-intensity statin); approximately 7% were treated with ezetimibe. Patients were randomised to a subcutaneous inclisiran sodium 300 mg injection, a second injection after 3 months, and then injec...



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