Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol

Analysis of 1561 and 1617 patients in ORION-10 and ORION-11 trials, respectively found that reductions in LDL cholesterol levels of ~50% were obtained with inclisiran, a small interfering RNA targeting hepatic PCSK9 synthesis, administered subcutaneously every 6 months.

SPS commentary:

Mean LDL cholesterol at baseline were 2.71±0.99 mmol/L and 2.73±1.01 mmol/L, respectively. In terms of the two primary end points, at day 510, inclisiran reduced LDL cholesterol levels by 52.3% in the ORION-10 trial and by 49.9% in the ORION-11 trial, with corresponding time-adjusted reductions of 53.8% and 49.2% (p<0.001 for all comparisons vs. placebo).


Data from the ORION 9 RCT (n=482) also published in the journal showed that patients on subcutaneous injections of inclisiran 300mg days 1, 90, 270, and 450 had significantly lower levels of LDL cholesterol vs. placebo, with an acceptable safety profile.


New England Journal of Medicine

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