JUPITER and JELIS part 2
The JELIS study was done a large cohort (about 18,000) of mainly middle aged Japanese females on low dose statins...The study has drawn a certain amount of criticism because even though it matched a treated (1.8gmEPA/day group), against a placebo, the study was not blinded. The other problem critics of JELIS raise is that the statin levels use were too low...Since statins do decrease inflammations, the argument raised is the anti inflammatory action of EPA could have been duplicated by increasing the statin dose. The other criticism which was made by an AHA spokesperson is the study failed to show improved survival, even though it did decrease CVD by about 20%..
I am a big fan of JELIS despite the above criticisms..JELIS was done on a cohort which on the whole was much healthier than average Americans adjusted for sex and age..The JELIS cohort is among the longest living on the planet...Most of them belonged to the group which have elevated LDL cholesterol and no history of heart attacks..We know from the statins outcomes studies just how hard it is to improve their outcomes..The non blinded issue is raised because Angina was one of the most common events and it is somewhat subjective..Careful examination of the JELIS results shows that for all the events measured there was a fairly consistent 20% improvement in the treated group. There were two exceptions..one was in the "sudden death" group which showed equal numbers in treated and non treated..and in fatal AMIs which were twice the number in the placebo...
There were no categories where placebo did better than EPA..Sudden death is a waste basket diagnosis..could be arrhythmia, CVA, poisoning..or suicide...or an AMI...The problem with JELIS is the patients were too healthy and so few died...only 27 of the 18,000 had fatal heart attacks in the five years JELIS ran...If all 27 fatal AMIs occurred in the placebo group it still would have barely been significant...
REDUCE-IT has learned its lesson from JUPITER and JELIS...The REDUCE-IT patients are being selected for risk..eg prior CVD events which signify high inflammatory levels...Statins outcomes studies prior to JUPITER showed you can not treat a condition (elevated inflammation) in individuals where it does not exist..The key to showing improved outcomes is selecting patients with high inflammation and then successfully lowering them.
IMHO..REDUCE-IT will be successful beyond any of the current expectations...because it is designed to succeed...This will convert to tremendous value for AMRN
":>) JL
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