News, literature and expert perspectives on PCSK9 inhibition
CME accredited Satellite Symposium held at ESC on August 26, 2017 in Barcelona focussed on 'PCSK9 inhibition & Cardiovascular Outcomes: Review of lipid targets and treatment strategies'
Data of the FOURIER and SPIRE trials called for an update of the 2016 ACC consensus paper on the role of non-statin therapies for LDL-C-lowering in the management of ASCVD risk.
EASD 2017 FOURIER sub-analysis shows that lowering LDL-C levels with evolocumab significantly and consistently reduced CV events also in patients with diabetes, without increasing the risk of new onset diabetes in non- or pre-diabetics.
ESC 2017 FOURIER trial data show that after 2.2 years of follow-up, very low LDL-c levels are still associated with further reduction of CV events, without an increase in safety events.
ESC 2017 A secondary analysis of the FOURIER analysis divided patients in five categories of achieved LDL-c after 4 weeks of evolocumab treatment. Patients with <0.5 mmol/L showed the lowest CV event rate.
ESC 2017 Safe and optimal treatment regimen identified for inclisiran, an siRNA against PCSK9, which is still effective after one year in the ORION-1 trial.
In the OSLER-1 and OSLER-2 open-label extension studies, treatment with evolocumab for the duration of 1 year had no apparent effect on glucose homeostasis, but led to a slight weight increase.
A large meta-analysis of nine studies confirmed association of PCSK9 loss-of-function variants with lower LDL-C levels and lower coronary heart disease risk, but not with stroke risk.
Anti-PCSK9 vaccination (AT04A) lowers LDL-c, atherosclerosis and inflammatory markers in mouse model for atherosclerosis. Phase I study into this vaccine has started
In a case-control study on HeFH patients treated with potent statins, the addition of a PCSK9 antibody resulted in a greater decrease of tendon xanthomas thickness after 3 years of treatment.
PCSK9 Expert Opinions Prof. Wouter Jukema summarizes the results from FOURIER and SPIRE into the message that PCSK9 inhibition works – even lower is even better; it is safe, and you cannot force biology – it takes a long time to get atherosclerosis, so it will also take some time to get rid of it.
PCSK9 Expert Opinions According to prof. Eric Bruckert, FOURIER is a landmark study that will change clinical practice, especially for patients with the highest risk.