Replies to post #229957 on Amarin Corp Plc (AMRN)

[Cardiologymd]

She does have diabetes but she is secondary prevention because the trial included people with peripheral vascular disease. Read the inclusion criteria.

[Atom0aks]

When you look at the inclusion criteria you will see that 80% carotid stenosis is not sufficient to establish CVD in this trial.

So, for these discussions specific to the R-IT patient populations, you may think of your mom as secondary prevention, but in reality she is not even primary prevention.

Isn't 80% carotid stenosis greater than 70% stenosis as defined by the REDUCE-IT protocol (emphasis mine)?

CV Risk Category 1: defined as men and women ≥45 years of age with one or more of
the following:
o Documented coronary artery d isease (CAD; one or m ore of the following prim ary
criteria must be satisfied):
• Documented multi vessel CAD (one or more >50% ste nosis in tw o major
epicardial coronary arteries – with or without antecedent revascularization);
• Documented prior MI;
• Hospitalization for high-risk NSTE ACS (w ith objective ev idence of is chemia:
ST-segment deviation or biomarker positivity).
o Documented cerebrovascular or carotid disease (one of the following prim ary criteria
must be satisfied):
• Documented prior ischemic stroke;
• Symptomatic carotid artery disease with ≥50% carotid arterial stenosis;
• Asymptomatic carotid artery disease with ≥70% carotid arterial stenosis per
angiography or duplex ultrasound;
• History of carotid revascularization (catheter-based or surgical).
o Documented peripheral arterial disease (PAD; one or m ore of the following prim ary
criteria must be satisfied):
• Ankle-brachial index (ABI) <0.9 with symptoms of intermittent claudication;
• History of aorto-iliac or peripheral ar terial intervention (catheter-based or
surgical).

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1812792

[sts66]

Two different issues here - 1) what criteria did AMRN use to define the R-IT primary prevention group, and 2) what is the medical definition of primary and secondary prevention for CVD - they're not going to be the same, and I'd bet that AMRN's definition is much tighter than the medical one, as AMRN wanted very sick patients in that group.