Amarin Corp Plc (AMRN)

[north40000]

Perhaps you might find the results below for me, a real patient, more of interest:

My doctor has termed my lipid profile as "excellent," and my cardiovascular risk as "optimally suppressed." Now 80 years old, I have no walking or arthritis difficulties.

My DES, Dry Eye Syndrome, disappeared within a week of initial Vascepa dosing.

Below are the 2016 and 2017 lipid panel marker values for me. I have been prescribed Vascepa[an oral capsule containing 96%(1 gram) of an omega-3 fatty acid known as EPA, or icosapent ethyl], Off-label, since 4/1/2013. Family history of CVDs and T1 D are in my background.

Generic Zocor = 40 mg dose > 20 years. T1 diabetic since 1957, 60 years duration. I had taken 32 units HumulinN and 7 units of Humalog in morning, as well as 4 units of HumalogN at bedtime for many years---those dosages are now reduced by 25% as described below.
HbA1c = 6.5; FBG= 111 mg/dL [About the same in 2017]

Total cholesterol = 144 mg/dL [April 2017 value: 125 mg/dL]
LDL-C = 70 mg/dL [April 2017 value: 57 mg/dL]
TGCs = 63. " [April 2017 value: 60 mg/dL]
HDL = 61. "
VLDL = 13. "

C-reactive protein = 2.2 mg/dL [April 2017 value: 1.4 mg/dL]

APO B = 60 mg/dL;
Lp-PLA2 = 216, termed very slightly elevated;
EPA/AA Ratio = 1.3; [April 2017 value is 1.6]
Omega-6/Omega-3 ratio = 1.8; [omega-6/omega-3 ratio = 1.6, April 2017]
EPA = 7.0% ; [7.8%, April 2017]
AA = 5.3%; [4.7%, April 2017]
DHA = 2.1%;

Omega-3(EPA + DHA) Index = 9.1%, optimal > 3.2%{April 2017 Index value is 10%]

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Another item that may be of interest to you in light of my T1 diabetes history. Over the past 2 years, I have slowly reduced the amount of insulin I had taken daily for many years; now that reduction amounts to 25%[24 units of HumulinN and 5 units of Humalog with breakfast]. I have done so to avoid the more frequent hypoglycemic episodes I slowly, but surely, had begun to experience. The following excerpt from my letter to my PCP in April 2017, and April 2017 articles, may explain why(you may already be aware of the articles):

"You and I have wondered for some time, particularly the past 4 years or so, how my fasting blood sugar levels and HbA1c levels have remained so well maintained.

The following articles[note the longer one is authored by Chinese researchers] from this past week may present the reason...the 1st link is a summary of the 2nd link:

http://www.medicalnewstoday.com/articles/316756.php

http://www.jci.org/articles/view/87388?key=bbb2df2018c8c18d1e0b

https://www.researchgate.net/profile/Marta_Garcia-Contreras2/publication/305676844_Combination_high-dose_omega-3_fatty_acids_and_high-dose_cholecalciferol_in_new_onset_type_1_diabetes_a_potential_role_in_preservation_of_beta-cell_mass/links/5798cae008aed51475e87894.pdf


I recall from initial consultations with you, early in my 1st visits as a patient 20 years ago, you thought it was worthwhile to explore whether my pancreatic beta cells, islet cells, were still producing at least some natural insulin. Whatever blood test was performed came back with a totally negative answer to that hypothesis, as I recall.

I think it is time, in light of the wake-up call provided by the above articles, to again investigate that hypothesis, inasmuch as I have been taking the off-label prescription of 4 capsules/day of Vascepa[each capsule containing 1 gm EPA or icosapent ethyl] for the past 4 years. You will recall we have discussed my serious hypoglycemic episodes occurring over the past year or 2, even with reduced dosages[by 25%] of HumulinN and Humalog that I have been taking vis a vis the prescribed levels of each I had taken for years.

I would appreciate an opportunity to talk with you re the above, as well as what further investigation is needed now to determine status of islet cells. Do we have frozen blood available/preserved from past visits in the last 4 years to determine progress, if any, with time as the variable, of my islet cells? I am thinking particularly of blood draws in 2013[before any Vascepa to get a baseline] and each subsequent year, especially 2017.[The answer was no]

I may present a rare case....a "clinical trial" of one T1 Diabetic. Because the Reduce-it Phase 3 clinical trial being conducted by Amarin, the sponsor, remains randomized and double-blinded as to the company, but not the IDMC, we do not know whether T1 Diabetics have been enrolled in that trial. I do not think they are excluded."