Re: What if RRR MACE is significant at 90% confidence?
in response to
by
posted on
Apr 24, 2018 11:13AM
I can't resist. I need to provide some criticism of that post.
"An average 8 percent rate is reported in our trial ongoing"
Yes, the past two presentations have claimed that "Projected primary MACE rate still 8.0 per 100 patient years on top of aggressive standard of care (low LDL) = strong unmet need"
"The targeted patients average 11-12 % in previous studies I believe"
The model patient population in the EXAMINE trial had ~11% event rate at 18 months. This is not the same as 11 events per 100 patient years. Just for the sake of simple math, let's call it 12%. 12% at 18 months. Divide by 1.5 years (to normalize to the 12 month or 1 year mark) and you are at 8%. 8% same as 8 per 100 patient years.
"So how do we get to 8% in our trial with half on Drug and half on Placebo? My bet is that its something like 11-12% event rate for the half on Placebo and 4-5% event rate for the other half on Drug. This would bring us to an 8% Average. The reduction in adverse events is large if this is close to being accurate. I may be all wrong on my opinion and welcome comments."
Lots of ways to get 8% average. The apabetalone/placebo split could be 8/8, 8.5/7.5, 9/7, 10/6, 11/5, so on and so on. There is nothing in the reported 8 per 100 patient year figure that tells us which of these is likely.
Just refiling your cup of joe with a health pour of reality. I'm still very optimistic for the trial, but you need to be careful about reading too much into what has been revealed to us so far.
BearDownAZ