Replies to post #229959 on Amarin Corp Plc (AMRN)

[IgnoranceIsBliss]

Read the inclusion criteria.

Let's all read the inclusion criteria for secondary prevention:

Table 1a. Inclusion Criteria for Secondary Prevention Risk Category.
Defined as men and women ≥45 years of age with one or more of the following:
1. Documented coronary artery disease (CAD; one or more of the following primary criteria
must be satisfied):
• Documented multi vessel CAD (≥50% stenosis in at least two major epicardial
coronary arteries – with or without antecedent revascularization);
• Documented prior MI;
• Hospitalization for high-risk non-ST-segment elevation acute coronary syndrome
(NSTE-ACS) (with objective evidence of ischemia: ST-segment deviation or
biomarker positivity).
2. Documented cerebrovascular or carotid disease (one of the following primary 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).
3. Documented peripheral arterial disease (PAD; one or more of the following primary
criteria must be satisfied):
• Ankle-brachial index (ABI) <0.9 with symptoms of intermittent claudication;
• History of aorto-iliac or peripheral arterial intervention (catheter-based or
surgical).

[AVII77]

a. Documented multivessel CAD (≥50% stenosis in ≥2 major epicardial coronary arteries, with or without antecedent revascularization)

I stand corrected.

The ADCOM was (in part) about the generalizability of the results.

Generalizability beyond those enrolled.

The consensus was indicated population should reflect those enrolled.

Amarin asked for an indicated population beyond those enrolled (no mention of diabetes for example).

But you seem to think the indicated population should reflect only those subgroups who showed SS w/o an additional trial.

Would you prescribe to a woman who had high risk despite optimized statin therapy with residual high trigs? That subgroup wasn't SS. Say, perhaps someone like your mom.

Which non SS subgroups would you insist on seeing more data and which ones would you ignore?

Amarin seems to have taken it to one extreme (no diabetes requirement, no mention of statins) and you the other (if a subgroup is not SS it shouldn't be in the indicated population).

My opinion is that the indicated population should reflect those enrolled (unless there is evidence of divergent treatment effects like in LEADER where the primary prevention point estimate suggested harm).