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factors of this population. Saxagliptin was well tolerated with monotherapy and in

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combination with other oral antihyperglycemic agents. This table provides a summary of

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adverse events based on an analysis of the placebo controlled pool population up to week

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24 including rescue therapy. The frequency of patients with adverse events treated with

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Saxagliptin 5 mgs was similar to placebo. 72.2% compared with 70.6%. There was no

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discernible difference in the clinical AE profile between the Saxagliptin 2.5 mgs and 5mg

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groups. Deaths and serious adverse events were infrequent and occurred at comparable

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frequencies between patients who received Saxagliptin and placebo.

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hypoglycemia, dermatologic safety, lymphocytes, and an overall summary of the

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general safety profile. Additional details of the Saxagliptin safety profile can be found in

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our briefing book. Our safety review will primarily focus on the cardiovascular profile

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with Saxagliptin, our initial assessments of CV safety reflected the concern with

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cardiovascular disease as the leading cause of morbidity and mortality in patients with

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type 2 diabetes. In addition, a comprehensive set of analyses were undertaken in light of

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recent final guidance from FDA on evaluating CV risk and will be presented later by Dr.

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Wolf.

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combination study with Metformin. AEs leading to discontinuation from study therapy

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were infrequent in all treatment groups and were reported in 2.2%, 3.3%, 3.9% and 1.8%

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of patients in the Saxagliptin 2.5 mg, 5 mg, 10 mg, and placebo groups, respectively. In

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contrast, as described in the briefing book, in the initial combination therapy study with

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Metformin, AEs leading to discontinuation were similar in each of the treatment groups,

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which contain Saxagliptin and in the Metformin monotherapy group.

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Dr. Wolf will also further describe the cardiovascular history and risk

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We also observed similar findings across treatment groups in our initial

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