WebNov 16, 2024 · ORION-10. For ORION-10, Wright and colleagues randomized 1,561 patients with ASCVD and elevated LDL cholesterol (≥ 70 mg/dL) already on maximally tolerated statins to receive placebo or four injections of inclisiran over 18 months (days 1, 90, 270, and 450). Of note, 10% of patients were taking concomitant ezetimibe over the course of … 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 …
NICE guidance on inclisiran should be reconsidered The BMJ
WebMar 18, 2024 · The objectives of the ORION-10 and ORION-11 trials were to assess the efficacy, safety, and adverse-event profile of inclisiran over a period of 18 months in … WebNov 8, 2024 · ORION-11 was a pivotal Phase III, placebo-controlled, double-blind, randomized study to evaluate the efficacy, safety and tolerability of Leqvio 300 mg, equivalent to 284 mg of Leqvio, administered subcutaneously by a healthcare professional. nsh external
Pooled ORION Analysis Details Inclisiran Effect on LDL-C in …
WebJan 7, 2024 · Background: Inclisiran, an siRNA administered twice-yearly, significantly reduced LDL cholesterol (LDL-C) in Phase III trials. Whether lowering LDL-C with inclisiran translates into a lower risk of cardiovascular (CV) events is not yet established. Methods and results: Patient-level, pooled analysis of ORION-9, -10 and -11, included patients with … 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 … WebNov 16, 2024 · The ORION program is studying the efficacy and safety of inclisiran in patients with ASCVD and FH, with ORION-9, ORION-10 and ORION-11 comprising the pivotal Phase 3 LDL-C lowering studies. nsh family practice