Two phase 3 trials of inclisiran in patients with elevated ldl cholesterol
New England Journal of Medicine Mar 24, 2020
Ray KK, Wright RS, Kallend D, et al. - Since previous studies propose that inclisiran might provide sustained reductions in low-density lipoprotein (LDL) cholesterol levels with infrequent dosing, researchers tried to find out the utility and safety of inclisiran in individuals with elevated LDL cholesterol. This study included individuals with atherosclerotic cardiovascular disease (ORION-10 trial) and individuals with atherosclerotic cardiovascular disease or an atherosclerotic cardiovascular disease risk equivalent (ORION-11 trial) who had elevated LDL cholesterol levels despite receiving statin therapy at the maximum tolerated dose. Individuals were allocated randomly in a 1:1 ratio to receive either inclisiran (284 mg) or placebo, administered by subcutaneous injection on day 1, day 90, and every 6 months thereafter over a period of 540 days. A sum of 1,561 and 1,617 individuals who had undergone randomization in the ORION-10 and ORION-11 trials, respectively. The study found approximately 50% reductions in LDL with inclisiran, administered subcutaneously every 6 months. Compared with placebo, more injection-site adverse events occurred with inclisiran.
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