Amarin 101 changed in March,2012 the Outcome study--Reduce-IT.
From : Incidence of Cardiovascularazation
To: Composite endpoint of CV death,MI,Stroke,Coronary revacularization and hospitalization for unstable angina.
Various studies--Recent one in JAMA on Fish Oil (mostly Over the counter Fish Oil) andORIGIN study -6 years-in NE journal of medicine--showed no significant benefit.
JELIS study: For Epadel--90% pure EPA sold in Japan--showed
1) 19% relative reduction in major Coronary events
2) Unstable angina and non fatal coronary events were also significantly reduced.
JELIS study enrolled 18645 patients from 1996-95 and was completed in 2005.It was the largest scientific study in Japan.
VASCEPA or AMR101 are highly purified EPA--Vascepa is 96% pure vs.Epadel 90% pure EPA.
Marine Trial data showed significant lowering of LDL and C-RP
What is C-RP? It is is GOLDEN MARKER for Inflammation and Coronary artery disease according to Dr.Eric Topol,Chief of Cleveland Clinic Cardiology dept.-rated #1 in USA.
What you want to look for is the sub group in the Jelis Trial ----combination of high TG's and low HDL --- there I think there was a 53 % reduction in events
I was interviewed by the Reduce trial group re participating in the trial ---they want patients with diabetes of 50 % stenois in 2 coronary arteries ( now with stents ) ---they are intent on this trial deciding once and for all , if high doses's of purified EPA reduce Tg's will this reduce heart attacks and other such "events "
The "event " lines in Jelis started to diverge after 2 yrs ---so dosing for Reduce it ,began late 2011 , so by late 2013 they should see trends developing.
An important note on the Jelis trial ---comprised of 69% Japanese women --who were eating fish at least 5 times a week
You may be better informed about patients they are seeking.
They may see results in 2013--but would Dr.Bhatt prematurely release results? I don't think so--as his reputation would be at stake.
Remember KEY VICTORY is to have data to convince FDA--to add NEW LABELING to VASCEPA.
With this NEW labeling,VASCEPA sales will soar--like LIPITOR as TV ads /Internet ads will say" VASCEPA Reduced Major Coronary events."
Mtd, thanks for posting. I agree wholeheartedly. As others have noted on this board, the Jelis study was a relatively healthy population with fish a staple in diet and still showed favorable results. The Reduce-It study is in a high risk population already with heart disease or at high risk for heart disease. It likely will improve upon the Jelis findings. The inclusion criteria for the study using Vascepa:
Men and non-pregnant or sterile women ages 45 and older
On statin therapy for at least four weeks
Either having established Cardiovascular Disease or at high risk for Cardiovascular Disease
Sentiment: Strong Buy
I believe strongly that VASCEPA will prove to be far more effective in reducing coronary events than Epadel. But more importantly:
1) Fish oil sold in over the counter are USELESS-ineffective.
2) Lovaza is unproven to reduce Coronary events.
3) Marine trial data is the only evidence so far for VASCEPA or AMR101.
In 2015 or 2016--OUTCOME STUDY will provide Scientific PROOF for VASCEPA.
Dr.Bhatt is very hopeful .