Nice post by G1945V on Stockhouse. In addition to the EXAMINE trial, which you all know I have obsessed about, Sarah advised G1945V of another cardiovascular outcomes trial that the company is/has used to influence BETonMACE design/expectations. In ALECARDIO, the investigators examined 3-point MACE events in subjects with type 2 diabetes and a recent ACS event treated with or without the PPAR alpha/PPAR gamma dual agonist aleglitazar.

At first glance, the patient population criteria of EXAMINE and ALECARDIO appear similar. However, the event rates in the two trials are quite different. Careful inspection of Figure 2 of the EXAMINE paper and Figure 2 of the ALECARDIO paper reveals that the 3-point event rates at a given time point in ALECARDIO were lower than observed in EXAMINE. For example, at 18 months about 11.5% of patients in EXAMINE had experienced a 3-point MACE event but in ALECARDIO only approximately 8% of patients had experienced a 3-point MACE event.

The data in Table 3 of EXAMINE and Table 2 of ALECARDIO is based upon the median follow up period. The median follow up period for EXAMINE was approximately 18 months, whereas it was 24 months for ALECARDIO. Although the table data for 3-point MACE incidence, as well as the incidence of the individual components, "appears" similar between the two trials, there is ~6 month difference in the point in time (duration on drug/follow up period) that the investigators are reporting. We can still see similarities in the breakdown of the cardio death, non-fatal MI and non-fatal stroke incidence in the two trials. Cardiovascular death occurs in 2.7% to 4.1% of patients, non-fatal MI occurs in 5.9% to 6.9% of patients, and non-fatal stroke occurs in 1.1% to 1.4% of patients.