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Sunday, July 27, 2014 9:27:07 PM
A very important point JELIS points out is the effect increasing "risk" has on outcomes studies. JELIS enrolled 18,645 patients. These patients were divided into primary or secondary interventions. Primary intervention is defined by patients not having a history of a serious CVD event. 14,981 JELIS patients fell into this group. Secondary intervention patients were those who had a history of a CVD event. 3664 JELIS patients had a positive history of a CVD event.
The reason for this division is that the risk of a patient having additional CVD events is much higher if a patient has had a previous one. In JELIS even though there 11,317 more patients in the primary group than the secondary, there were more CVD events 335 in the secondary group, than there were in the primary, only 231.
Remember in the JELIS secondary group there was a total of 355 events in 3664 patients...That was 197 events in control and 158 in the EPA group. This was stat sig for everything but mortality rates. The annual event rate for the statin only 2ndary group was only 2.3%. This is less that half the estimated event rate in the R-IT trial..(our patients are much sicker) also the JELIS secondary group was only 3664 patients which is about half the number in REDUCE-IT..JELIS ran for four and half years..We should be able to see much more in half that time..
":>) JL
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