analytic techniques to access the consistency of the results. We use methods developed
by the FDA as well as our own methods for these analyses. We also employed blinded
external review of MACE to confirm our results. We analyzed CV endpoints in the
phase 2b/phase 3 pool population, in sub groups defined by increased risk for CV events,
and in individual trials. While there are limitations to the retrospective applications of
the FDA guidance to the Saxagliptin clinical database, the results of these analyses are
consistent with the FDA criterion for excluding an unacceptable cardiovascular risk.
for Saxagliptin. It has not escaped our attention that a cardioprotective effect of
Saxagliptin is possible. Given the limitations of the current data, a cardioprotective effect
can only be hypothesized at this time. However, we are currently planning studies to
rigorously test the hypothesis cardioprotection.
Saxagliptin and provide a rationale for approval of this product. There is epidemic
growth in the prevalence of type 2 diabetes in the US and worldwide, many patients are
not achieving treatment goals for glycemic control. Due to progression of this disease,
monotherapy of type 2 diabetes often fails requiring most patients to require a
combination therapy. Effective combinations often target complementary mechanisms of
action to address the multiple metabolic defects of type 2 diabetes. There are safety and
tolerability concerns for some existing agents.
To summarize, we analyze multiple cardiovascular events using multiple
I would like to now provide some comments on the benefit risk profile for
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these cases by treatment group was very similar to the distribution for primary MACE.
Thus this external review was consistent with a lack of a CV safety signal for Saxagliptin.
The major importance of these analyses is to exclude a CV safety signal