Replies to post #89546 on Amarin Corp Plc (AMRN)

[HDGabor]

y-

Yes, JELIS wasn't a double blinded trial ... but it wasn't a full open label.

we used an open interventional design, with blinded clinical endpoint assessment (PROBE design) to keep bias to a minimum.23 The PROBE design has the advantages of low costs and similarity to standard clinical practice, which should make the results easily applicable in routine medical care; however, we cannot exclude the possibility of bias in some of the physician-initiated endpoints, such as coronary revascularisation and hospital treatment for unstable angina. ... Local physicians monitored compliance with dietary advice and medication, and noted adverse events at every clinic visit. Clinical endpoints and severe adverse events reported by local physicians were checked by members of a regional organising committee in a blinded fashion. Then, an endpoints adjudication committee (see webappendix), consisting of three expert cardiologists and one expert neurologist, con? rmed them once a year without knowledge of the treatment allocation.

Best,
G

[jessellivermore]

yellow..

Perhaps you did not notice that my comments do not depend to any degree on the trial design, or even the results. As a matter of fact the trial was open label, blinded endpoint trial..

To me the most remarkable thing about JELIS; the thing that confers the greatest predictive value of JELIS to R-I. is The EPA levels are higher, and the CVD event rates lower, in the composite, active and Placebo arms of the secondary prevention group than in R-I...The facts are the event rates regardless of which arm or the total are so much lower in JELIS than a group of Americans with similar CVD health protocols. And all this with lousy LDL-C levels and low statin doses..

Years of passed since the JELIS results and so far the only the only plausible explanation for these low CVD rates are the high EPA levels in the JELIS population in both active and control arms...This hypothesis is supported by JELIS which confirmed the low EPA levels were associated with high CVD risk regardless of the patient being in the control or active arm...There is no way this result could have been fudged...

":>) JL