Real-world evidence shows that the majority of patients do not achieve their LDL-c target goals. Where do we fall short in the need for combination therapy?
The new therapeutic options for LDL-c lowering, bempedoic acid and inclisiran, are discussed by prof. Ballantyne. How do these drugs lower LDL-c and what are the findings in phase III programs?
The NHS has made an agreement on a population health management approach in those eligible for the PCSK9 siRNA inclisiran.
ESC 2021 This pooled, post-hoc analysis of ORION-9, -10, and -11 showed that inclisiran significantly reduced LDL-c compared placebo in patients with and without polyvascular disease.
EAS 2021 A pooled data analysis of ORION-9, 10 and 11 showed no changes in hematological and immunological biomarkers in patients with ASCVD or risk equivalent treated with inclisiran over a treatment period of 540 days.
This pooled patient-level analysis of three phase 3 trials (ORION-9, -10 and -11) shows that inclisiran reduces LDL-c on average by 50.7% compared to placebo in patients on maximally tolerated statin-therapy.
Experts in dialogue In this video, prof. Mach and prof. Stroes answer the question: How are we performing in Europe with regard to LDL-c goal attainment in very high risk patients?
Inclisiran has received approval from the European Commission (EC) for the treatment of adult patients with atherosclerotic CVD (ASCVD), ASCVD-risk equivalent and heterozygous FH.
Following the results from the ORION program, the CHMP of EMA has issued a positive opinion on inclisiran to reduce LDL-c in patients with hypercholesterolemia or mixed dyslipidemia.
EAS 2020 In a cohort of high-risk primary prevention individuals, 6-monthly injections with inclisiran reduced LDL-c and other atherogenic lipoproteins compared to placebo.
EAS 2020 A subanalysis of ORION-9 showed that lowering of LDL-c by inclisiran was similar across subgroups of genotypes in those with heterozygous FH.
Inclisiran, an siRNA against PCSK9, did not result in adverse effects on measures of inflammation, immune activation and platelets. No clinical immunogenicity AEs were observed.