Replies to post #227539 on Amarin Corp Plc (AMRN)

[Whalatane]

Cmm. The primaries in R-It were the diabetics who had not had an “ event “ and also had 1 additional risk factor plus TG’s over 135 mg/ dL

There were no non diabetics primary prevention patients in R-It as far as I know

The discussion post Adcom was why wait till some one has an “ event “ or becomes diabetic . There is a risk to UNDER prescribing such a safe and effective med as Vascepa

Let’s move down the risk scale acknowledging the benefit may not be as great but will certainly be better than Ezetimibe or doing nothing
JMO
Kiwi

[Atom0aks]

Thus, I'm still unsure Amarin, presenters, FDA and panelists, were using the terms Primary prevention and Secondary prevention uniformly.

Primary and secondary prevention patients as defined by the REDUCE-IT study can be summarized as,

Primary: Patients with diabetes and risk factors for cardiovascular disease (i.e. prevention of cardiovascular disease)

Secondary: Patients with cardiovascular disease (i.e. prevention of additional cardiovascular disease)

As you pointed out, the REDUCE-IT definition of primary prevention patients is a very narrow definition of primary prevention and is a reason for the AdCom as shown by this discussion,

3. DISCUSSION: The applicant has proposed an indication for cardiovascular risk reduction in adult patients with triglyceride levels greater than 135 mg/dL and additional risk factors for cardiovascular disease (CVD), without regard for age, diabetes status, or adequacy of lowdensity lipoprotein (LDL-C) control. Please discuss the population – beyond the subset of patients with established CVD – for whom you believe the data from REDUCE-IT provide evidence of cardiovascular risk benefit, addressing the following factors:
• Age
• Diagnosis of diabetes
• Additional risk factors for CVD
• Plasma LDL-C concentration
• Plasma triglyceride concentration
• Intensity of statin therapy
• Any other factor you believe is important

Source: https://www.fda.gov/media/132472/download

The discussion that ensued over how to incorporate these populations into the label is probably why it sounded like these definitions were not being used uniformly.