Amarin Corp Plc (AMRN)

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Question re definition of Primary vs Secondary prevention.

Are the two terms being used uniformly in the label discussion?

Is the "prevention" part of the definition a reference to CVD, alone, or is it a reference only to prevention of a MACE event?

From the protocol,

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).
OR
CV Risk Category 2: defined as patients with:
1. Diabetes mellitus (Type 1 or Type 2) requiring treatment with medication AND
2. Men and women ≥50 years of age AND
3. One of the following at Visit 1 (additional risk factor for CVD):
• Men ≥55 years of age and Women ≥65 years of age;
• Cigarette smoker or stopped smoking within 3 months before Visit 1;
• Hypertension (blood pressure ≥140 mmHg systolic OR ≥90 mmHg diastolic) or on antihypertensive medication;
• HDL-C ≤40 mg/dL for men or ≤50 mg/dL for women;
• hs-CRP >3.0 mg/L;
• Renal dysfunction: Creatinine clearance (CrCL) >30 and <60 mL/min;
• Retinopathy, defined as any of the fo llowing: non-proliferative retinopathy, preproliferative retinopathy, proliferative retinopathy, maculopathy, advanced diabetic eye disease or a history of photocoagulation;
• Micro- or macroalbuminuria. Microalbuminuria is defined as either a positive micral or other strip test, an albumin /creatinine ratio ≥2.5 mg/mmol or an albumin excretion r ate on tim ed collection ≥20 mg/min all on at least two successive occasions; macroalbuminuria, defined as albustix or other dipstick evidence of gross proteinuria, an album in/creatinine ratio ≥25 mg/mmol or an albumin excretion rate o n timed collection ≥200 mg/min all on at least two successive occasions;
• ABI <0.9 without sym ptoms of interm ittent claudication (p atients with ABI <0.9 with symptoms of intermittent claudication are counted under CV Risk Category 1).
Note: Patients with diabetes and vascular disease as defined above are eligible based on the vascular disease requirements and will be counted under CV Risk Category 1. Only patients with diabetes and no documented CV disease as defined above need at least one additional risk factor as listed, and will be counted under CV Risk Category 2.

Source: https://www.nejm.org/doi/suppl/10.1056/NEJMoa1812792/suppl_file/nejmoa1812792_protocol.pdf