WebNov 24, 2024 · 3项研究都有相似的研究终点，在相同的给药方案中使用相同剂量的300 mg inclisiran钠（相当于284 mg inclisiran），并且具有相同的就诊时间表。 共有3660名参与者（分别来自ORION-9、-10 和-11的n=482、n=1561和n=1617接受了随机化。 WebNov 14, 2024 · The investigators conducted a patient-level, pooled analysis of ORION-9, ORION-10, and ORION-11, and included patients with heterozygous familial hypercholesterolemia, atherosclerotic CV disease (ASCVD), or ASCVD risk equivalent on maximally tolerated statin therapy, randomized 1:1 to receive 284 mg inclisiran or placebo …
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WebThe ORION-10 and the ORION-11 were two randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trials. The objectives of the ORION-10 and ORION-11 trials were to assess the efficacy, safety, and adverse-event profile of … WebApr 12, 2024 · The ORION-8 trial (NCT03814187) is the open-label, long-term extension of the ORION-9, ORION-10, ORION-11 and ORION-5 studies . This trial will evaluate the safety and efficacy of inclisiran in achieving lipid targets among 2991 patients with HeFH, HoFH, established ASCVD or ASCVD risk equivalents, followed up for 1080 days [ 25 ]. fly ash cladding
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Web• Two Phase 3 trials (ORION-10 and ORION-11) were reported in a single publication. In both trials, eligible patients had an elevated LDL-C despite receiving maximally tolerated statin doses ... ORION 9. 3 . Inclisiran 300 mg vs. placebo SQ HeFH (n=482) 18 months R, DB, PC, MC Inclisiran 300 mg SQ vs. placebo given on day 1, 90, 270 and 450 ... 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) … WebSep 4, 2024 · PARIS – A small interfering RNA drug, inclisiran, safely halved LDL cholesterol levels in more than 800 patients in a phase 3, multicenter study, in a big step toward this drug coming onto the market and offering an alternative way to harness the potent cholesterol-lowering power of PCSK9 inhibition. – A small interfering RNA drug, inclisiran fly ash catalyst