WebTrial Design — A randomized, phase 3, placebo-controlled, double blind, parallel assignment randomized clinical trial to evaluate the effect of 300 mg of Inclisiran sodium given as … WebORION-10 and ORION-11; § The diagnosis of familial hypercholesterolemia was based on genetic confirmation and/or established phenotypic Simon Broome criteria ASCVD, atherosclerotic cardiovascular disease; CV, cardiovascular; ITT, intent-to-treat; IQR, interquartile range; LDL-C, low-density lipoprotein cholesterol
Leqvio®* (inclisiran) reduced LDL-C in people who are ... - Novartis
WebDec 23, 2024 · Methods: In this post hoc analysis of the ORION-9, ORION-10, and ORION-11 trials, patients were randomized 1:1 to receive 284 mg inclisiran (300 mg inclisiran sodium) or placebo on day 1, day 90, and 6-monthly thereafter. WebNov 25, 2024 · The Phase 3 ORION-10 and ORION-11 trials randomized patients with established ASCVD (or risk-equivalents) with LDL-C >70 mg/dl despite maximally tolerated statins to inclisiran or placebo (1:1). Inclisiran sodium 300 mg was administered s.c. at baseline, three months later, then every six months. immediate correction lead
ORION-10 Phase III Trial Details - American Heart Association
WebMay 12, 2024 · Pooled analysis of ORION-9, ORION-10, and ORION-11: Mean percent change in LDL-C at 510 days: -51 in the inclisiran group compared with 4 in the placebo group (p < 0.0001). This was a time-averaged 52% reduction in LDL-C for inclisiran vs. placebo. At least one treatment-emergent adverse event: 78.0% with inclisiran vs. 77.3% with placebo WebMar 28, 2024 · The ORION-11 trial showed that twice yearly inclisiran injection reduced LDL-C by 50%. Description: The goal of the trial was to evaluate inclisiran compared with … WebMar 30, 2024 · The ORION trial program now includes new data pooled from ORION-9, -10, and -11 showing reduction in LDL-C of 51% when used in addition to other lipid-lowering therapies (LLT) over 17 months of treatment. A prespecified exploratory analysis using safety from the 3 trials also indicated fewer major adverse cardiovascular events (MACE) … immediate correction 意味