There were 18,645 people in the JELIS trial.
Out of 18,654 people only 63 people were the TOTAL difference between EPA + Statin group and the Statin alone Control group. Just 63 people?
OVERALL - "We detected the primary endpoint in 262 patients in the EPA plus Statin group and 324 in control group (Statin alone)"
Out of the 9300+ people taking Statin alone --- 324 suffered major coronary events.
Out of the 9300+ people taking EPA + Statin --- 262 suffered major coronary events.
324 - 262 = 63 people out of 18,645 who EPA helped?
In patients with a history of coronary artery disease, 39 more people suffered events when taking Statin alone.
In patients with no history of coronary artery disease 23 more people suffered events when taking Statin alone.
Only 63 people TOTAL out of 18,654 people might have been helped by the EPA?
IS THIS SIGNIFICANT?
People keep complaining about JELIS and I am beginning to be swayed. Just google JELIS results and read. Clear as day 18,645 total participants. Of the patients suffering events 63 more people suffered events in the control group than in the EPA group.
FINDINGS: At mean follow-up of 4.6 years, we detected the primary endpoint in 262 (2.8%) patients in the EPA group and 324 (3.5%) in controls-a 19% relative reduction in major coronary events (p=0.011).
Unstable angina and non-fatal coronary events were also significantly reduced in the EPA group. Sudden cardiac death and coronary death did not differ between groups. In patients with a history of coronary artery disease who were given EPA treatment, major coronary events were reduced by 19% (secondary prevention subgroup: 158 [8.7%] in the EPA group vs 197 [10.7%] in the control group; p=0.048). In patients with no history of coronary artery disease, EPA treatment reduced major coronary events by 18%, but this finding was not significant (104 [1.4%] in the EPA group vs 127 [1.7%] in the control group; p=0.132).
Sentiment: Strong Buy
"EPA might have helped 63 people out of 18,645."
Wait just a minute....You just told us there was just 324 CVD events in the 9300 pt control group...it seems logical to conclude that in a control group of 18,600 there should be roughly 648 CVD events..This would seem to be the group at risk in this study..You can not say the remainder of the group was at risk, since nothing happened. So really EPA helped 63 people in the 324 risk group...we can conclude it would have helped those in the control group if they would have been lucky enough to be on it...So the actual figure is 126 pts out 648...or more than 20%...Not too bad...
Statistics are like a bikini...What the reveal is fascinating...What they conceal, more fascinating...
": ) JL
Sentiment: Strong Buy
Yes the numbers are sketchy. The 23 people who had no history of coronary artery disease is deemed statistically NOT SIGNIFICANT. The 39 people who had a history of coronary artery disease appear to meet statistically SIGNIFICANT range. With numbers like this, further studies are needed to help determine outcome benefits. This much is agreed by 100% of the research community.
Let's say 50,000,000 US adults could be on Vascepa and statin (actually estimates are higher), the number of lives spared a major cardio event would be 1,325,000. Over One million patients would be spared if REDUCE-IT matches the #s from JELIS Trigs over 150 and HDL below 40.
Are you aware of the requirements for people to be included in the JELIS trial??? 117mg/dL of total cholesterol or higher. That is it. Healthy people, healthy diets. If you look at the sub-group of patients who resemble REDUCE-IT, Trigs over 150mg/dL and HDL
Yup, it's called statistics, and significant findings were found in a relatively healthy population in an overall population that is among the healthiest on earth, the Japanese. The other thing about the findings was the graph showed a continuous and growing gap between Epadel + statin vs. placebo + statin. The sub-group showed a 53% improvement in reducing adverse heart events, (triglycerides 150 or above + HDL 40 or below), and the pattern was similar on a graph with reductions in adverse heart events accelerating over time. The REDUCE-IT population resembles the sub-group and actually is people far more in need of what Vascepa provides. V works doubly well in trials with 4G vs. 2G, while the JELIS study was only 1.8G. REDUCE-IT has statistically a tremendous chance of succeeding and fairly quickly. No other trial started with triglyceride reducers to show improvement in CHD had a JELIS to back their contentions.
Sentiment: Strong Buy
Remember that the JELIS study looked at a lower risk population than reduce-it is studying. Even so the absolute risk reduction of 0.7% (3.5-2.8) leads to a number of patients needed to treat (NNT) to prevent one event of 143. Not bad for a product that doesn't have much in the way of side effects.
All of this discussed in the thread plus potential results from Reduce-it is exactly why we have an advisory meeting coming IMO! Its not about ANCHOR data itself which is strong.
How all of this gets parsed politically in that meerting to come plays a role in whether ANCHOR gets approved quicker or slower! its not about whether it gets approved, but the timeline for approval in the vastly larger population of patients!