begin by describing the CV risk profile in the phase 2b/phase 3 pool population. The
presence of type 2 diabetes in and of itself is a significant risk factor for future CV events
as noted in various epidemiologic studies. 80% of the patients in our pool phase 2b/phase
3 population had at least one of the four additional risk factors for cardiovascular events
that are listed on this slide.
MACE and primary MACE, is shown at the bottom of the slide. There were 40 patients
with custom MACE and 41 patients with primary MACE. There were 40 patients in the
overlap. In other words, custom MACE and primary MACE identified nearly identical
sets of patients differing by a single individual. This is important because the results for
primary MACE will be nearly identical to the results for custom MACE.
factors including male gender and duration of type 2 diabetes. Our statistical analysis
plan specified primary MACE as the primary endpoint for assessment of the
cardiovascular safety profile for Saxagliptin. Accordingly, the next few slides will focus
Next I will summarize the results of our analysis of CV events. I will
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SMQ MACE and acute CV events. However, there were clear differences in these two
populations as shown. Among the patients with SMQ MACE but not acute CV events, a
majority were accounted for by the single preferred term, a blood creatine phosphokinase
increase, which was in the FDAs definition of SMQ MACE.
cardiovascular disease upon entry to the phase 2b/phase 3 studies defined as a prior
history of myocardial infarction, heart failure, angina pectoris, coronary, carotid or
peripheral vascular disease or prior revascularization procedures.
The relationship of the two most narrowly defined endpoints, custom
There are 569 patients in our experience who had clinically evident