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Friday, February 17, 2017 4:39:33 PM
Based on what JT has said in the past, I think it means that the composite rate is where they projected it to be at this point, given their assumed placebo event rate and assumed efficacy of V when they started the study. That doesn't prove that V is working as intended, but at least where we are now is consistent with V working as planned. The only ways to get to the composite rate where we are now that is consistent with projections that does not involve V working as intended is: 1) both groups are having fewer events than in past similar studies in similar populations on statins, or 2) V makes people worse and the placebo group is doing great. #1 seems unlikely given that the sample is apparently about 70% diabetic (someone posted that yesterday), has elevated Trigs, and 50% also have low HDL), and #2 would be inconsistent with all prior studies of EPA. I don't buy Pyr's thesis of a high % of dropouts in the placebo group - Moderate trig elevations as in R-it are not a treatment target for cardiologists, even if patients see them and discover their trigs have not lowered. There is also little incentive to drop out and start using V outside of the study because it is not yet a proven treatment. Why would they spend money on V when no one knows yet whether it does anything to reduce risk? My suspicion is that many of the study patients are using the planned study visits as free ongoing cardiac care and may no be seeing their regular cardiologists intensively during the study.
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