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Message: Re: 188 Mace events?
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Mar 10, 2018 02:04PM

Nextblockbuster,

We've discussed this at length on this board already! It sounds to me like you are assuming that just because 2200 or more patients are enrolled that 13% of them should magically have already have experienced an adjudicated 3-point MACE event. 

1) Some patients started back in November 2015. Perhaps others started yesterday. The number of patients is meaningless without a time factor. Number of patients multiplied by time in trial gives you patient years.

2) Resverlogix (Clayton) recently confirmed that the average observed event rate is approximately 8 events per 100 patient years. However, we don't know what the placebo/apabetalone split is. Note: if this 8 events per 100 patient years is a true figure, then these are extremely sick patients. To my knowledge, none of the other CVOT trials in diabetes patients (including the SGLT2, GLP1-R agonists, DPP4 inhibitors, or the thiazolidinediones) approached this event rate with the exception of EXAMINE, which was also around 8% (for both placebo and alogliptin groups). If truly apabetalone is substantially reducing MACE, then this means that the placebo group is having an event rate in far excess of 8 per 100 patient years. 

3) Using the approximate event rate in #2 with estimates of the number of patient years, my estimate is that by end of Q1 we will be in the range of 165 to 216 events. The wide range is because our first enrollment update wasn't until September 2016, whereas enrollment started in November 2015. So lots of uncertainty there that creates a range of possibilities for patient years.

4) I get a similar range (175 to 200) for the end of Q1 if I extrapolate from the company provided enrollment numbers at key dates, combined with the event rates reported in the EXAMINE trial.

5) It takes time to officially adjudicate events. So even if x number of events have occurred, they won't be officially added to the tally until they are adjudicated.

 

 

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