InvestorsHub Logo

jessellivermore

07/28/14 7:07 AM

#31239 RE: Whalatane #31233

KIWI...

These trials and the stats are all about the numbers. Forget about whether or not there were more smokers among Japanese women than Eastern European males(something I find hard to believe); just look at the numbers. The calculated risk of CVD in R-IT is 5% annual in the statin only group. This number is calculated by actuaries and takes into account whether they are primary or secondary interventions, whether they are smokers, overweight, eat too much salt etc.

We know what the risk was in JELIS because we know how many events occurred. We know in the secondary intervention group the risk was 2.3% annual. The primary group was much lower. 2.3% is less than half of 5%.

Forget about more intensive care. The 5% estimated risk in the R-IT group is calculated with the understanding they are taking a full load of statins, and eating their veggies. The idea in R-IT is not to change the lifestyles of the trial participants, it's to add four grams of EPA/day and see if this makes a difference.

Please read the part of my post that says the CVD improvement in JELIS was significant except for mortality..The reason it was not significant is the death rate was too low. IMO if you double the cohort and double the risk; the case here, there is a substantial chance you will see a significant decrease in mortality in the EPA group.

Someone ask if there might be a reason to continue R-IT past the point of significant CVD reduction...One reason would be to achieve mortality significance if nesessay

Have a nice day....":>) JL

BioChica

07/28/14 10:02 AM

#31246 RE: Whalatane #31233

Reduce-It Exclusion Criteria:

Severe heart failure
Any life-threatening disease other than Cardiovascular Disease
Active severe liver disease
Hemoglobin A1c >10.0%
Poorly controlled hypertension
Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure
Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)
Known hypersensitivity to fish oil products
History of acute or chronic pancreatitis

Patients are excluded if using the following medications:
niacin >200 mg/day or fibrates;
any omega-3 fatty acid medications ;
dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
bile acid sequestrants