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which you are hearing today, and Liraglutide, which you will hear about tomorrow. You

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may notice that presentations differ slightly, and that’s because FDA picked the subset of

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analysis that we feel best represents cardiovascular risk for each of the products.

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analyses and you will hear more about this from our statisticians over the course of the

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two days. First, FDA requested that results for these cardiovascular analyses be stratified

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by study. This preserves randomization and is particularly important when there is

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unequal randomization in a study. FDA also requested that an exact method be used for

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at least one analysis, and you will hear from the biostatisticians the value in using these

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techniques later today and tomorrow. As you can see FDA requested multiple analyses,

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two treatment periods, two endpoints, multiple comparators in some cases, various

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statistical methodologies. The goal of these multiple analyses was to look at the data in

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different ways to assist consistency of results.

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today and while they are hearing the discussions over the course of the day - The

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Saxagliptin and Liraglutide new drug applications were submitted to FDA prior to

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publication of the cardiovascular guidance. In fact, they were both submitted to FDA

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prior to the July 2008 advisory committee meeting. These programs were not

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prospectively designed for systematic measurement of cardiovascular risk.

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Cardiovascular event rates were low. There were no pre-specified definitions for major

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cardiovascular events of interest. For example, these programs didn’t say that for an

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Importantly, FDA used the same statistical approach for Saxagliptin,

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A few important considerations for the panel during their deliberations

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infarction is included is SMQ MACE but not in custom MACE. Whereas, myocardial

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infarction or silent myocardial infarction are included in both.

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A quick word on the statistical analysis for these cardiovascular safety

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