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analytic techniques to access the consistency of the results. We use methods developed

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by the FDA as well as our own methods for these analyses. We also employed blinded

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external review of MACE to confirm our results. We analyzed CV endpoints in the

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phase 2b/phase 3 pool population, in sub groups defined by increased risk for CV events,

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and in individual trials. While there are limitations to the retrospective applications of

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the FDA guidance to the Saxagliptin clinical database, the results of these analyses are

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consistent with the FDA criterion for excluding an unacceptable cardiovascular risk.

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for Saxagliptin. It has not escaped our attention that a cardioprotective effect of

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Saxagliptin is possible. Given the limitations of the current data, a cardioprotective effect

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can only be hypothesized at this time. However, we are currently planning studies to

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rigorously test the hypothesis cardioprotection.

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Saxagliptin and provide a rationale for approval of this product. There is epidemic

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growth in the prevalence of type 2 diabetes in the US and worldwide, many patients are

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not achieving treatment goals for glycemic control. Due to progression of this disease,

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monotherapy of type 2 diabetes often fails requiring most patients to require a

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combination therapy. Effective combinations often target complementary mechanisms of

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action to address the multiple metabolic defects of type 2 diabetes. There are safety and

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tolerability concerns for some existing agents.

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To summarize, we analyze multiple cardiovascular events using multiple

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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.

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Thus this external review was consistent with a lack of a CV safety signal for Saxagliptin.

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The major importance of these analyses is to exclude a CV safety signal

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