MACE Event rate,....

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Cabel

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MACE Event rate,....

posted on Feb 28, 2019 10:58AM

BearDownAZ,

Now that we know we are 230 as of mid Feb. Therefore if we say we had about 195 at the AGM (they said about 200).

So if we do 230 - 195 = 35 MACE events

From mid Sept to mid Feb or 5 months = 7 MACE events per month

If you divide that by 2200 patients (1200 taking RVX-208, 1200 taking placebo and of that 200 dropouts) you get an annual MACE event rate of .035% for the last 5 months.

That seems awfully low.

I understand that we probably have a better standard treatment than the EXAMINE trial, but we also have sicker patient population (ie less time since last MACE event, and other criteria)

In the EXAMINE trial we see:

In the trial, 5380 patients with established T2DM who had a recent acute coronary syndrome event (between 15 and 90 days) were randomized to treatment with either alogliptin or placebo. To better understand and describe the CV safety of alogliptin, we analyzed data from the EXAMINE trial to determine whether treatment with alogliptin affected recurrent and total CV events. Poisson regression analysis compared the total number of occurrences of CV death, MI, stroke, unstable angina, and coronary revascularization between all patients randomized to alogliptin vs placebo groups. Patients with recurrent CV events were older and more likely to have renal disease and history of heart failure. There were 1100 first CV events and an additional 666 recurrent events over a median of 18 months of follow-up. There were no significant differences with regard to total number of events in patients treated with alogliptin (n = 873) or placebo (n = 893; P = 0.52).

We see in the EXAMINE trail we had 5380 patients and alot more events (1766 in all),...

Even if we count just the 1100 first events we are much higher in the joint (placebo and treated events) MACE event rate than we are in our trial.

BearDownAZ,... please help me understand why out event rate is so low as compared to the EXAMINE trial,... even if all the events wee in the placebo group (which is unlikely) it would still be an extremely low event rate.

Please excuse all the math errors in my post as I really know very little about the science part.