MACE than for the broad or inclusive SMQ MACE. Again, this difference between
custom MACE and SMQ MACE is largely accounted for by including the term, ‘blood
creatine phosphokinase increase’ in the FDA’s definition for SMQ MACE. We do not
see evidence of a cardiovascular safety signal for Saxagliptin based on these analyses.
The risk ratios for primary MACE and acute CV events are summarized on the next slide.
death at the bottom of the slide. Consistent with our other analyses, we did not see
evidence for increased risk of death among Saxagliptin exposed patients. The risk ratios
for custom MACE and SMQ MACE are summarized on the next slide. When the results
for all three analytic methods for custom MACE and SMQ MACE are depicted together,
there is a consistent pattern for the upper bound with a 95% confidence interval for risk to
be well within the FDA defined criterion for approvability.
Drs. John Alexander and Ken Mahaffey at the Duke Clinical Research Institute to
perform a blinded review of the clinical data for all patients with SMQ MACE, primary
MACE in all deaths. They review case report forms, narratives and source documents
like discharge summaries and ECG’s without knowledge of treatment group assignment.
They independently identified 40 cases of MACE in this data set. The distribution of
I want to call your attention to the data for all-cause of death and CV
The estimates of the risk ratio were lower for the more selected custom
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consistent results for these Sponsor defined cardiovascular endpoints. The upper bound
of the 95% confidence intervals for the risk ratio for the pool analyses were below 1.1 for
The Cox hazard ratio, incidence rate ratio, and incidence ratio all gave
Again, well within the FDA criterion for approvability. We have asked