Replies to post #262837 on Amarin Corp Plc (AMRN)

[mc1988]

Ignoring my claim about whether there exist at least one patient with triglycerides level >500 mg/dL, I find a bigger issue in Hayashi is that the judge relies on Hayashi's conclusion that is based on statistically non-significant values.

Specifically, on page 27 of the bench order https://www.courtlistener.com/recap/gov.uscourts.nvd.118340/gov.uscourts.nvd.118340.381.0_1.pdf the judge states:

Hayashi discloses that “[a]fter 8 weeks, patients treated with ethyl icosapentate showed significant reductions in . . . triglyceride (41%),” and reports reductions in LDL-C (7%) and apolipoprotein B (7%), which was not statistically significant. (Ex. 1532 at 5.) Hayashi therefore concludes that “[p]urified icosapentate (1800 mg/d for 8 weeks) decreased total cholesterol and triglyceride in patients with FCH (Table I),” and that “[n]o overt effects of icosapentate on plasma LDL-C and HDL-C were seen, although a decrease in LDL-C was noted (Table I).” (Id. at 7.)

The quoted parts are from Hayashi's "Discussion and Conclusion" section on page 28 https://sci-hub.tw/https://www.sciencedirect.com/science/article/pii/0011393X95850163

Purified icosapentate (1800 mgld for 8 weeks) decreased total cholesterol and triglyceride in patients with FCH (Table I). No overt effects of icosapentate on plasma LDL-C and HDL-C were seen, although a decrease in LDL-C was noted (Table I). Thus it would appear that icosapentate may have antiatherogenic effects on plasma lipid profiles, since high levels of both plasma total cholesterol and triglyceride have been shown to be coronary risk factors.18-21 Although the effects of fish oils on plasma LDL-C and HDL-C are complex,6 judging from the present study, purified icosapentate apparently has no deleterious effect on plasma LDL-C or HDL-C in patients with FCH.

When Hayashi says "although a decrease in LDL-C was noted (Table I)", he refers to Table I, copied below:


Note that the change is statistically NOT significant.

That said, Hayashi's claim that "purified icosapentate apparently has no deleterious effect on plasma LDL-C or HDL-C in patients with FCH" appears to be correct.

This post is probably not relevant for the legal case, but I thought I'd point that out in case it might matter. I'm primarily disappointed that of all the various studies related to effects of EPA, the defendant is able to convince the judge based on a cherry picked study.