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microscopic evidence of cardiotoxicity and did not see evidence of adverse

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electrophysiologic or hemodynamic effects of Saxagliptin. In our phase 1 clinical

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program, we studied Saxagliptin at doses up to 80x the proposed usual clinical dose. We

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did not see an adverse effect on lipid parameters, blood pressure, heart rate, or QT

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interval. For another member of the DPP-4 class, currently approved for clinical use in

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the United States, published data indicated no meaningful differences in the incidence

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rates for cardiac related or ischemia related adverse experiences. Thus the data available

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to us prior to our analyses of the phase 2b, phase 3 clinical program did not suggest that

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CV risk would be associated with Saxagliptin.

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methods was to assess the consistency of our results given the retrospective nature of

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many of our assessments. We use endpoints and methods defined by both us and by the

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agency. I would now like to provide some context for our assessment of CV safety in the

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phase 2b/phase 3 clinical programs.

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in the Saxagliptin clinical program. While we analyze CV events defined by us and by

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the Agency it is important to know if the analyses of these events were based upon a

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common database and common analytic methods. For all pooled analyses we use

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In non-clinical studies performed on multiple species, we did not see

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I will now provide an overview of the methods used to analyze CV events

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our overview, we analyzed acute CV events prior to submitting the NDA for

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Saxagliptin. We also retrospectively applied FDA guidance on evaluating CV risks to the

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clinical data for Saxagliptin by assessing multiple additional types of CV events utilizing

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multiple analytic methods.

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The intent at using multiple types of CV events and multiple analytic

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