TY - JOUR
T1 - Inclisiran for the treatment of cardiovascular disease: The ORION clinical development program
AU - Stoekenbroek, Robert M.
AU - Kallend, David
AU - Wijngaard, Peter Lj
AU - Kastelein, John Jp
PY - 2018
Y1 - 2018
N2 - Inclisiran is a novel drug that inhibits PCSK9 synthesis specifically in the liver, harnessing the natural mechanism of RNAi. Phase I and II data show that inclisiran lowers low-density lipoprotein cholesterol levels on average by >50% with a duration of effect that enables twice-yearly dosing. Phases I, II and emerging Phase III data support inclisiran's safety, tolerability and risk-benefit profile. The ongoing ORION program includes Phase III trials that will provide robust evidence of inclisiran's safety and efficacy in individuals at high risk of atherosclerotic cardiovascular disease (ASCVD), including established ASCVD and familial hypercholesterolemia. In addition, the ORION-4 trial will assess the impact of inclisiran on cardiovascular outcomes in approximately 15,000 ASCVD subjects.
AB - Inclisiran is a novel drug that inhibits PCSK9 synthesis specifically in the liver, harnessing the natural mechanism of RNAi. Phase I and II data show that inclisiran lowers low-density lipoprotein cholesterol levels on average by >50% with a duration of effect that enables twice-yearly dosing. Phases I, II and emerging Phase III data support inclisiran's safety, tolerability and risk-benefit profile. The ongoing ORION program includes Phase III trials that will provide robust evidence of inclisiran's safety and efficacy in individuals at high risk of atherosclerotic cardiovascular disease (ASCVD), including established ASCVD and familial hypercholesterolemia. In addition, the ORION-4 trial will assess the impact of inclisiran on cardiovascular outcomes in approximately 15,000 ASCVD subjects.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85058153276&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/30375244
U2 - https://doi.org/10.2217/fca-2018-0067
DO - https://doi.org/10.2217/fca-2018-0067
M3 - Article
C2 - 30375244
SN - 1479-6678
VL - 14
SP - 433
EP - 442
JO - Future cardiology
JF - Future cardiology
IS - 6
ER -